K182070 · BioHorizons Implant Systems, Inc. · DZE · Oct 10, 2018 · Dental
Device Facts
Record ID
K182070
Device Name
BioHorizons Tapered IM Implants
Applicant
BioHorizons Implant Systems, Inc.
Product Code
DZE · Dental
Decision Date
Oct 10, 2018
Decision
SESE
Submission Type
Special
Regulation
21 CFR 872.3640
Device Class
Class 2
Attributes
Real-World Evidence
Real-World Evidence
Submission
Device
Sponsor
RWD Sources
RWE Use Summary
Key Tags
K182070 · Oct 10, 2018
BioHorizons Tapered IM Implants
BioHorizons Implant Systems, Inc.
Published clinical literature (Nevins et al. 2008, Ricci et al. 2000)
The sponsor relies on published clinical literature to support the safety and effectiveness of the Laser-Lok surface technology, specifically regarding connective tissue attachment and bone response.
Literature review; Human histologic evidence; Bone response
Clinical Evidence
Study Design
Population
Comparator
Key Endpoints
Nevins et al. Human Histologic Evidence of a Connective Tissue Attachment to a Dental Implant; Human histologic study
Human subjects
Not applicable for this study
Connective tissue attachment to dental implant
Ricci et al. Bone Response to Laser Microtextured Surfaces; Clinical/Experimental study
—
Not applicable for this study
Bone response to laser microtextured surfaces
Indications for Use
BioHorizons Tapered IM Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.
Device Story
BioHorizons Tapered IM Implants are machined titanium alloy (ASTM F136) screw-form endosseous dental implants. Features include Resorbable Blast Texture (RBT) surface treatment and Laser-Lok micro-machined grooves on the collar to inhibit epithelial downgrowth and promote connective tissue attachment. Used by dental surgeons in the mandible or maxilla for tooth replacement or dental retention. Implants are provided sterile via gamma irradiation. Clinicians use the device as an artificial root structure; the output is the physical implant itself, which provides a foundation for prosthetic restoration. Clinical benefit includes restoration of chewing function and dental aesthetics.
Clinical Evidence
Bench testing only. Comparative dimensional assessment confirmed structural equivalence to predicates. Dynamic mechanical fatigue testing (ISO 14801) performed on worst-case implant-abutment assemblies, surviving 5 million cycles. Sterilization validated per ANSI/AAMI/ISO 11137-1. Endotoxin testing performed per ANSI/AAMI ST72, meeting USP <161> limits. No clinical data presented.
Indicated for use in the mandible or maxilla as an artificial root structure for single tooth replacement, fixed bridgework, or dental retention. May be restored immediately with a non-functional temporary prosthesis, or when splinted for multiple tooth replacement, or stabilized with an overdenture supported by multiple implants.
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.
Predicate Devices
BioHorizons Tapered Internal Plus Implants (K121787)
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October 10, 2018
BioHorizons Implant Systems, Inc. Michael Davis Director, Regulatory Affairs 2300 Riverchase Center Birmingham, Alabama 35244
Re: K182070
Trade/Device Name: BioHorizons Tapered IM Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: September 7, 2018 Received: September 11, 2018
Dear Michael Davis:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Andrew I. Steen -S
for Tina Kiang, Ph.D. Acting 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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| Indications for Use | Food and Drug Administration | | 510(K) Number (if known)<br>Device Mame | | | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|--|-------------------------------------------------------------------------------------------------------------------|--|--|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| See PRA Statement below | isquration Date: 06/30/2020 | | | | | | | |
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| | | | | | | | BioHorizons Tapered IM Implants | |
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| | | | | | | | Type of Use (Select one or poth, as applicable) | |
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| (D) Presscription Use (Part 21 CFR 801 Subpart D) | | | | | | | | |
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| of this information collection, including suggestions for reducing this purder, to: | | | | | | | | |
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| Delivery of Health and Human Services | | | | | | | | |
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| PRASStaff@gda.hhs.gov | | | | | | | | |
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## 510(k) Summarv 21 CFR 807.92
### Submitter's Name & Address
| Manufacturer: | BioHorizons Implant Systems, Inc.<br>2300 Riverchase Center<br>Birmingham, AL 35244<br>Phone (205) 967-7880<br>Fax (205) 870-0304 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Official contact: | Michael Davis, Director, Regulatory Affairs |
| Date prepared: | October 10, 2018 |
# Name of the Device
| Trade Name: | BioHorizons Tapered IM Implants |
|------------------------|---------------------------------|
| Common or Usual Name: | Screw-type dental implant |
| Classification Name: | Endosseous dental implant |
| Classification Number: | Class II (21 CFR 872.3640) |
### Predicate Devices
Primary Predicate Device:
- 1. K121787, BioHorizons Tapered Internal Plus Implants, September 5, 2012.
# Reference Predicate Devices:
- 1. K103691, BioHorizons Abutments for Zimmer, November 3, 2011.
- 2. K151621, BioHorizons CAD/CAM Abutments, January 13, 2016.
- 3. K071638. BioHorizons Tapered Internal Implant System, October 10, 2017.
- 4. K071161, Endosseous Dental Implant System, November 16, 2007.
### Device Description
The BioHorizons Tapered IM Implants are machined titanium, screw-form endosseous dental implants supplied in 7.0mm and 8.0mm diameters. Both implants include a 5.7mm prosthetic The implants are provided in 7.5mm, 9.0mm and 10.5mm lengths across both platform. diameters. Implant material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surqical Implant Applications.
The devices are further processed by roughening the threaded surface with Resorbable Blast Texture (RBT) media (hydroxylapatite) and by micro-machining grooves, known as Laser-Loke microchannels, on the implant collar. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10°, validated in compliance with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
### Indications for Use
BioHorizons Tapered IM Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.
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# Technological Characteristics
The fundamental scientific technology of the BioHorizons Tapered IM endosseous dental implant devices subject to this 510(k) is substantially equivalent to the primary predicate device. The threaded portion of the implants is RBT-blasted, and Laser-Lok microchannels are applied to the implant collar.
Laser-Lok is a surface feature in which patterns of micro-machined grooves are applied to the collar of a dental implant, providing a roughened surface to establish a physical, connective tissue attachment. This tissue connection:
- 1) is functionally oriented,
- 2) inhibits epithelial cell downgrowth, and
- 3) enables crestal bone adjacent to the implant to attach and be retained
The preceding claims are supported in the published literature by Nevins et al. Human Histologic Evidence of a Connective Tissue Attachment to a Dental Implant, International Journal of Periodontics & Restorative Dentistry 2008; 28:111-121 and Ricci et al. Bone Response to Laser Microtextured Surfaces, Bone Engineering 2000:382-392.
All materials, suppliers, processing, packaging and sterilization methods remain the same as for the primary predicate device, BioHorizons Tapered Internal Plus Implants (K121787). The Laser-Lok feature is substantially equivalent to that cleared for the BioHorizons Tapered Internal Plus Implants. The BioHorizons Tapered IM Implants are substantially equivalent to the features of the predicate implant devices because of the similarities in design, materials and intended use. Refer to Table 1, Summary Table of Substantial Equivalence, immediately following.
### Summary of Testing
A comparative dimensional assessment was performed comparing the worst-case subject Tapered IM implant d…
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