Zimmer 3.1mmD Dental Implants are designed for use in the anterior maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Zimmer 3.1mmD Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to minimally support the implant (minimum 1mm circumferential and 2mm apical). The Zimmer 3.1mmD Dental Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region. The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex are used for attachment of restorations requiring off-axis correction. The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex are designed to be used in edentulous or partially edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement. The 2.9mm Contour Abutment and the 2.9mm Contour Abutment, Straight Hex are used as a terminal or intermediate abutment for a cemented prosthesis. Abutment can be used for a single- or multiple-unit restoration. The 2.9mm Angled Contour Abutment and the 2.9mm Angled Contour Abutment, Straight Hex are designed to be used as a terminal or intermediate abutment for a cemented prosthesis where the angle needs to be offset by 17°. Abutment can be used for a single- or multiple-unit restoration. The 2.9mm Temporary Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The 2.9mm Temporary Abutment can be used for cement-retained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations. The Ball Abutment is used for retaining overdentures or partial dentures when resilience and facilitated oral hygiene are desired. The Healing Collar is used to assist in the forming of the soft tissue during healing before a final restoration is placed. The Healing Collar is for single use only. The Healing Screw is used to seal the implant internal connection and separate it from the soft tissue which is sutured over the implant during healing. The Retaining Screws are intended to be used for securing the temporary abutments, final abutments and impression transfers to the implant or implant analog. The long Retaining Screw is intended to be used with Temporary Abutments for fabrication of screw-retained provisional restorations and with Impression Transfers for direct impressions.
Device Story
Zimmer 3.1mmD Dental Implant System comprises titanium alloy endosseous implants, prosthetic abutments, and ancillary components (healing collars/screws). Implants feature tapered bodies with triple-lead threads and MTX surface treatment to facilitate osseointegration. System used by dental clinicians in clinical settings for tooth replacement. Implants placed in anterior maxilla/mandible; prosthetic components (angled, contour, temporary, ball abutments) attached via retaining screws to support fixed/removable restorations or overdentures. Device provides structural foundation for dental prosthetics; aids in soft tissue healing. Clinicians select components based on anatomical needs (e.g., off-axis correction, esthetic emergence). System supports immediate or delayed loading protocols. Benefits include restoration of masticatory function and esthetics for edentulous/partially edentulous patients.
Clinical Evidence
No clinical data. Substantial equivalence supported by non-clinical bench testing, including fatigue and compression testing per FDA guidance for root-form dental implants, and MRI safety/compatibility testing per ASTM F 2182.
Indicated for patients with missing teeth in the anterior maxilla or mandible requiring endosseous dental implants for single or multiple tooth replacement, including immediate loading or conventional healing. Contraindicated for use in the molar region; requires splinting in the pre-molar region.
Regulatory Classification
Identification
An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.
Special Controls
*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
*Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol of three stylized human profiles facing right. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2014
Zimmer Dental, Inc. Christina Boydston Quality Manager 1900 Aston Ave. Carlsbad. California 92008-7308
Re: K142082
> Trade/Device Name: Zimmer 3.1mmD Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 28, 2014 Received: July 31, 2014
Dear Ms. Boydston,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any
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Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Susan Runno DDS, MA
Erin I. Keith, M.S Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/2 description: The image shows the logo for Zimmer Dental. The logo features a large, light blue letter Z in a circular shape. Below the letter Z, the word "zimmer" is written in a smaller, sans-serif font, and below that, the word "dental" is written in an even smaller font.
# Indications for Use
K142082 510(k) Number (if known):
Device Name: Zimmer 3.1mmD Dental Implant System
Indications For Use:
Zimmer 3.1mmD Dental Implants are designed for use in the anterior maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Zimmer 3.1mmD Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to minimally support the implant (minimum 1mm circumferential and 2mm apical). The Zimmer 3.1mmD Dental Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.
The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex are used for attachment of restorations requiring off-axis correction. The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex are designed to be used in edentulous or partially edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement.
The 2.9mm Contour Abutment and the 2.9mm Contour Abutment, Straight Hex are used as a terminal or intermediate abutment for a cemented prosthesis. Abutment can be used for a singleor multiple-unit restoration. The 2.9mm Angled Contour Abutment and the 2.9mm Angled Contour Abutment, Straight Hex are designed to be used as a terminal or intermediate abutment for a cemented prosthesis where the angle needs to be offset by 17°. Abutment can be used for a single- or multiple-unit restoration.
The 2.9mm Temporary Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The 2.9mm Temporary Abutment can be used for cementretained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations.
The Ball Abutment is used for retaining overdentures or partial dentures when resilience and facilitated oral hygiene are desired.
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The Healing Collar is used to assist in the forming of the soft tissue during healing before a final restoration is placed. The Healing Collar is for single use only.
The Healing Screw is used to seal the implant internal connection and separate it from the soft tissue which is sutured over the implant during healing.
The Retaining Screws are intended to be used for securing the temporary abutments, final abutments and impression transfers to the implant or implant analog. The long Retaining Screw is intended to be used with Temporary Abutments for fabrication of screw-retained provisional restorations and with Impression Transfers for direct impressions.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Page 17 of 997
Zimmer Dental 900 Aston Avenue arlsbad, CA 92008 60.929.4300 (ph) 60.431.7811 (fax)
# Traditional 510(k) PRE-MARKET NOTIFICATION 510(k)
# 510(k) SUMMARY (21CFR807.92(a))
### Submitter's Information: 1.
| Name: | Zimmer Dental Inc. |
|----------------|--------------------|
| Address: | 1900 Aston Ave. |
| | Carlsbad, CA 92008 |
| Phone: | 760-929-4150 |
| Contact: | Christina Boydston |
| Date Prepared: | July 28, 2014 |
- 2. Device Name:
Trade Name: Regulation Number: Classification Code: Device Classification Name:
Trade Name: Regulation Number: Classification Code: Device Classification Name:
Trade Name: Regulation Number: Classification Code: Device Classification Name:
Trade Name: Regulation Number: Classification Code: Device Classification Name:
Trade Name: Regulation Number: Classification Code: Device Classification Name:
Trade Name: Regulation Number: Classification Code: Device Classification Name: Zimmer 3.1mmD Dental Implant 872.3640 DZE Implant, Endosseous, Root-Form
2.9mm Angled Abutment 872.3630 NHA Abutment, Implant, Dental, Endosseous
2.9mm Angled Abutment, Straight Hex 872.3630 NHA Abutment, Implant, Dental, Endosseous
2.9mm Contour Abutment 872.3630 NHA Abutment, Implant, Dental, Endosseous
2.9mm Contour Abutment, Straight Hex 872.3630 NHA Abutment, Implant, Dental, Endosseous
2.9mm Temporary Abutment 872.3630 NHA Abutment, Implant, Dental, Endosseous
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Trade Name: Regulation Number: Classification Code: Device Classification Name:
Trade Name: Regulation Number: Classification Code: Device Classification Name:
Trade Name: Regulation Number: Classification Code: Device Classification Name:
#### 3. Predicate Device(s):
Predicate Device No. 1 Trade Name: 510(k):
Regulation Number: Classification Code: Device Classification Name:
Predicate Device No. 2 Trade Name: 510(k): Regulation Number: Classification Code: Device Classification Name:
Predicate Device No. 3 Trade Name: 510(k): Regulation Number: Classification Code: Device Classification Name:
Predicate Device No. 4 Trade Name: 510(k): Regulation Number: Classification Code: Device Classification Name: 2.9mm Ball Abutment 872.3630 NHA Abutment, Implant, Dental, Endosseous
2.9mm Healing Collar 872.3630 NHA Abutment, Implant, Dental, Endosseous
2.9mm Healing Screw 872.3630 NHA Abutment, Implant, Dental, Endosseous
Tapered Screw-Vent Implant K011028, K013227, K061410, K072589, K101977, K111889 872.3640 DZE Implant, Endosseous, Root-Form
Screw-Vent Dental Implant K011028, K013227, K061410 872.3640 DZE Implant, Endosseous, Root-Form
Ospol Dental Implant System K070184 872.3640 DZE Implant, Endosseous, Root-Form
Zimmer Dental Inc. 20° Angled Abutment K011028 872.3630 NHA Implant, Endosseous, Root-Form
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Predicate Device No. 5 Trade Name: 510(k): Regulation Number: Classification Code: Device Classification Name:
Predicate Device No. 6 Trade Name: 510(k): Regulation Number: Classification Code: Device Classification Name:
Predicate Device No. 7 Trade Name: 510(k): Regulation Number: Classification Code: Device Classification Name:
Predicate Device No. 8 Trade Name: 510(k): Regulation Number: Classification Code: Device Classification Name:
Predicate Device No. 9 Trade Name: 510(k): Regulation Number: Classification Code: Device Classification Name: Zimmer Dental Inc. 3.5mm Hex-Lock Abutment K052600 872.3630 NHA Implant, Endosseous, Root-Form
Zimmer Dental Inc. Temporary Plastic Abutment K092377 872.3630 NHA Implant, Endosseous, Root-Form
Zimmer Dental Inc. Screw-Vent Ball Abutment K011028 872.3630 NHA Implant, Endosseous, Root-Form
Zimmer Dental TSV Healing Collars K11852 872.3630 NHA Implant, Endosseous, Root-Form
Zimmer Dental Surgical Cover Screw K011028 872.3630 NHA Implant, Endosseous, Root-Form
### 4. Device Description:
The Zimmer 3.1mmD Dental Implant System consists of 3.1mm threaded endosseous dental implants, as well as prosthetic components, and ancillary components for placement and restoration of these implants. The prosthetic components include 2.9mm Angled Abutment, 2.9mm Angled Abutment, Straight Hex, 2.9mm Contour Abutment, 2.9mm Contour Abutment, Straight Hex , 2.9mm Temporary Abutment, and 2.9mm Ball Abutment. The 2.9mm Angled, 2.9mm Contour, and 2.9mm Temporary Abutments are made to
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support single or multiple unit restorations. The 2.9mm Ball Abutments are made to support overdentures. The ancillary components for the Zimmer 3.1mmD Dental Implant System include 2.9mm Healing Collars and 2.9mm Healing Screws which are used during the healing process.
Zimmer 3.1mmD Dental Implant is an endosseous dental implant composed of titanium alloy. The implant body is designed for ease of implantation and with greater surface area for osseointegration. The implant surface is treated to facilitate osseointegration. In addition, the implant body is tapered with triple-lead threads. The Zimmer Dental 3.1mmD Dental Implant is currently offered in 3.1mm diameter in lengths of 8, 10, 11.5, 13, and 16mm. They include two different texturing configurations: full texture to the top of the implant and texture to 0.5mm from the top of the implant. In addition, both texturing configurations of the implant have coronal grooves on the collar to within 0.64mm of the top of the implant similar to the predicate #1: Tapered Screw-Vent Implant Dental Implant. The implant-abutment interface platform diameter will be offered in a size of 2.9mm. The new device will feature MTX surface equivalent to existing Zimmer Dental implants.
The Abutments, Healing Collars, and Healing Screw are titanium alloy devices that are made to mate with the Zimmer 3.1mmD Dental Implant, which is also made of titanium alloy. The abutments are designed for use as a terminal or intermediate abutment prostheses.
### ನ. Indications for Use:
Zimmer 3.1mmD Dental Implants are designed for use in the anterior maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Zimmer 3.1mmD Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to minimally support the implant (minimum 1mm circumferential and 2mm apical). The Zimmer 3.1mmD Dental Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.
The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex and are used for attachment of restorations requiring off-axis correction. The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex are designed to be used in edentulous or partially edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement.
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The 2.9mm Contour Abutment and the 2.9mm Contour Abutment, Straight Hex are used as a terminal or intermediate abutment for a cemented prosthesis. Abutment can be used for a single- or multiple-unit restoration. The 2.9mm Angled Contour Abutment and the 2.9mm Angled Contour Abutment, Straight Hex are designed to be used as a terminal or intermediate abutment for a cemented prosthesis where the angle needs to be offset by 17°. Abutment can be used for a single- or multiple-unit restoration.
The 2.9mm Temporary Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The 2.9mm Temporary Abutment can be used for cement-retained or screw-retained provisional restorations. The abutments can be used for single-unit and multiunit restorations.
The Ball Abutment is used for retaining overdentures or partial dentures when resilience and facilitated oral hygiene are desired.
The Healing Collar is used to assist in the forming of the soft tissue during healing before a final restoration is placed. The Healing Collar is for single use only.
The Healing Screw is used to seal the implant internal connection and separate it from the soft tissue which is sutured over the implant during healing.
The Retaining Screws are intended to be used for securing the temporary abutments, final abutments and impression transfers to the implant or implant analog. The long Retaining Screw is intended to be used with Temporary Abutments for fabrication of screw-retained provisional restorations and with Impression Transfers for direct impressions.
### Device Comparison:
Zimmer Dental believes the new devices presented in the Zimmer 3.1mmD Dental Implant System to be substantially equivalent to their respective predicate. Furthermore, Zimmer Dental believes the Zimmer 3.1mmD Dental Implant system to be substantially equivalent to the previously cleared Tapered Screw Vent and Screw Vent Implant Systems originally cleared in K011028, K013227, K061410, K072589, K101977, and K111889. The new Zimmer 3.1mmD Dental Implant System is substantially equivalent to predicates devices relative to material, general design features, as well as design and manufacturing process. The differences are the implant/abutment interface, platform sizes and the implant diameter which are similar to predicate device 2 and predicate device 3.
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### 6. Technological Characteristics
# Table 1: General Implant Device Comparison
| | New Device 1 | Predicate 1 | Predicate 2 | Predicate 3 |
|----------------------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-------------------------------------------------|
| Feature | Zimmer 3.1mmD<br>Implant | Tapered Screw-Vent<br>Implant | Screw-Vent<br>Dental Implant | Ospol Dental<br>Implant System |
| Implant<br>Interface | Internal Hex<br>Conical Connection | Internal Hex | Internal Hex | Conical<br>Connection |
| Lengths | 8mm, 10mm,<br>11.5mm, 13mm,<br>16mm | 8mm, 10mm, 11.5mm,<br>13mm, 16mm | 8mm, 10mm,<br>13mm, 16mm | 8.0mm, 10mm,<br>12mm 15.0mm |
| Diameters | 3.1mm | 3.7 mm, 4.1 mm,<br>4.7mm, 6.0mm | 3.3mm,<br>3.7mm, 4.7mm | 4.0mm |
| Material | Titanium 6Al-4V<br>ELI | Titanium 6Al-4V ELI | Titanium 6Al-<br>4V ELI | Commercially<br>Pure Titanium |
| Collars | Machined surface<br>and texture, with<br>grooves<br>or<br>Texture to the top<br>with grooves | Machined Surface and<br>Texture<br>or<br>Machined surface and<br>texture, with grooves<br>or<br>Texture to the top with<br>grooves | Machined<br>Surface and<br>Texture | Ospol Surface<br>Texturing<br>(Oxidized + Ca+2) |
| Thread Pattern | Triple lead threads | Triple lead threads | Single Lead | Single Lead |
| Surface<br>Characteristics | MTX Surface | MTX Surface and MP-<br>1 HA | MTX Surface<br>and MP-1 HA | Ospol Surface<br>Texturing<br>(Oxidized + Ca+2) |
## Table 2: General Prosthetic Device Comparison
| Feature | New Device 2 | Predicate 4 |
|-------------------------------|----------------------------------------------------------------|--------------------------------------------------------------|
| | 2.9mm Angled Abutment | Zimmer Dental Inc. 20° Angled Abutment |
| Implant/Abutment<br>Interface | Internal Hex, Friction fit<br>Conical Connection, Friction fit | Internal Hex, Friction fit |
| Abutment Angles | 20° | 20° |
| Platform Diameter | 2.9mm | 3.5mm, 4.5mm, 5.7mm |
| Material | Titanium 6Al-4V ELI | Titanium 6Al-4V ELI |
| Method of Attachment | Retaining screw | Retaining screw |
| Feature | New Device 3<br>2.9mm Angled Abutment,<br>Straight Hex | Predicate4<br>Zimmer Dental Inc. 20° Angled Abutment |
| Implant/Abutment<br>Interface | Straight Internal Hex<br>Conical Connection, Friction fit | Internal Hex, Friction fit |
| Abutment Angles | 20° | 20° |
| Platform Diameter | 2.9mm | 3.5mm, 4.5mm, 5.7mm |
| Material | Titanium 6Al-4V ELI | Titanium 6Al-4V ELI |
| Method of Attachment | Retaining screw | Retaining screw |
| Feature | New Device 4<br>2.9mm Contour Abutment | Predicate 5<br>Zimmer Dental Inc. 3.5mm Hex-Lock<br>Abutment |
| Implant/Abutment<br>Interface | Internal Hex, Friction fit<br>Conical Connection, Friction fit | Internal Hex, Friction fit |
| Abutment Angles | Straight 17° | Straight 17° |
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| Platform Diameter | 2.9mm | 3.5mm, 4.5mm, 5.7mm | |
|-------------------------------|-----------------------------------------------------------|-----------------------------------------------------|------------------------------------------------------------|
| Material | Titanium 6Al-4V ELI | Titanium 6Al-4V ELI | |
| Method of Attachment | Retaining screw | Retaining screw | |
| | <b>New Device 5</b> | | <b>Predicate 5</b> |
| Feature | 2.9mm Contour Abutment,<br>Straight Hex | | Zimmer Dental Inc. 3.5mm Hex-Lock<br>Abutment |
| Implant/Abutment<br>Interface | Straight Internal Hex<br>Conical Connection, Friction fit | | Internal Hex, Friction fit |
| Abutment Angles | Straight, 17° | Straight, 17° | |
| Platform Diameter | 2.9mm | 3.5mm, 4.5mm, 5.7mm | |
| Material | Titanium 6Al-4V ELI | Titanium 6Al-4V ELI | |
| Method of Attachment | Retaining screw | Retaining screw | |
| | <b>New Device 6</b> | <b>Predicate 6</b> | <b>Predicate 5</b> |
| Feature | 2.9mm Temporary Abutment | Zimmer Dental Inc.<br>Temporary Plastic<br>Abutment | Zimmer Dental Inc.<br>3.5mm Hex-Lock<br>Abutment, Straight |
| Implant/Abutment<br>Interface | Straight Internal Hex<br>Conical Connection, Friction fit | Internal hex | Internal hex,<br>Friction fit |
| Abutment Angles | Straight | Straight, 17° | Straight |
| Platform Diameter | 2.9mm | 3.5mm, 4.5mm,<br>5.7mm | 3.5mm, 4.5mm,<br>5.7mm |
| Material | Titanium 6Al-4V ELI | PEEK-<br>CLASSIX™ | Titanium 6Al-4V ELI |
| Method of Attachment | Retaining screw | Retaining screw | Retaining screw |
| | <b>New Device 7</b> | | <b>Predicate 7</b> |
| Feature | 2.9mm Ball Abutment | | Zimmer Dental Inc. Screw Vent Ball<br>Abutment |
| Implant/Abutment<br>Interface | Internal Threading | Internal Threading | |
| Platform Diameter | 2.9mm | 3.5mm, 4.5mm, 5.7mm | |
| Material | Titanium 6Al-4V ELI | Titanium 6Al-4V ELI | |
| Method of Attachment | Ball abutment threads into<br>implant | | Ball abutment threads into implant |
Table 3: General Ancillary Device Comparison
| Feature | New Device 8<br>2.9mm Healing Collars | Predicate 8<br>Zimmer Dental TSV Healing<br>Collars |
|-------------------------------|---------------------------------------|-----------------------------------------------------|
| Implant/Abutment<br>Interface | Internal Threading | Internal Threading |
| Platform Diameter | 2.9mm | 3.5mm, 4.5mm, 5.7mm |
| Material | Titanium 6Al-4V ELI | Titanium 6Al-4V ELI |
| Method of Attachment | Healing collar threads into implant | Healing collar threads into implant |
| Feature | New Device 9<br>2.9mm Healing Screw | Predicate 9<br>Surgical Cover Screw, Titanium |
| Implant/Abutment<br>Interface | Internal Threading | Internal Threading |
| Platform Diameter | 2.9mm | 3.5mm, 4.5mm, 5.7mm |
| Material | Titanium 6Al-4V ELI | Titanium 6Al-4V ELI |
| Method of Attachment | Healing screw threads into implant | Healing screw threads into implant |
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### 7. Non-Clinical Testing:
Non-clinical test data was used to support the decision of substantial equivalence. Non-clinical testing consisted of performance of fatigue and compression testing in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments. The testing indicates that the new devices are strong enough to withstand the anticipated forces and demonstrated improvements over the predicate device(s).
Additionally, Zimmer Dental implant systems were evaluated for interactions with magnetic fields during Magnetic Resonance Imaging (MRI) in accordance with the FDA Guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment and ASTM F 2182: Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants during Magnetic Resonance Imaging. This was done to determine the presence of the dental implant or abutment poses no additional restrictions on MRI beyond those that would otherwise occur for the patient.
### 8. Clinical Testing:
No clinical testing was performed. Non-clinical testing was used to support the decision of substantial equivalence.
- Conclusion: 9.
Based on our analysis, the devices are substantially equivalent to their predicates.
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
