Who is the manufacturer of ATLANTIS Abutment for CONELOG implant?

Dentsply Sirona filed the 510(k) submission for ATLANTIS Abutment for CONELOG implant (K161030).

What is the FDA product code for ATLANTIS Abutment for CONELOG implant?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for ATLANTIS Abutment for CONELOG implant?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ATLANTIS Abutment for CONELOG implant?

ATLANTIS™ Abutment for NobelActive 3.0 (K151039); Osseospeed™ Profile EV (K130999); CONELOG Implant System (K113779).

Who can help prepare an FDA 510(k) submission like ATLANTIS Abutment for CONELOG implant?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ATLANTIS Abutment for CONELOG implant

K161030 · Dentsply Sirona · NHA · Aug 26, 2016 · Dental

Device Facts

Record ID	K161030
Device Name	ATLANTIS Abutment for CONELOG implant
Applicant	Dentsply Sirona
Product Code	NHA · Dental
Decision Date	Aug 26, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The ATLANTIS™ Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the ATLANTIS Abutment to the endosseous implant. The ATLANTIS™ Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTIS Crown Abutment to the endosseous implant. The ATLANTIS™ Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment screw is intended to secure the ATLANTIS Conus Abutment to the endosseous implant.

Device Story

Patient-specific endosseous dental implant abutments; fabricated via CAD/CAM technology at Dentsply sites based on clinician prescription. Inputs: clinician-provided anatomical/restorative data. Device transforms inputs into custom-designed titanium alloy abutments (straight or up to 30° angulation). Used in dental clinics by dentists/specialists to support crowns, bridges, or overdentures. Output: physical abutment secured to implant via screw; serves as substructure for final restoration or as final restoration itself (Crown Abutment). Benefits: provides patient-specific prosthetic interface for dental implants, restoring function and aesthetics in edentulous patients.

Clinical Evidence

Bench testing only. Evidence includes mechanical design analysis, dimensional analysis, and static/dynamic compression-bending testing per ISO 14801. Compatibility analysis confirms fit with CONELOG implant platforms (3.3, 3.8, 4.3, 5.0 mm). No clinical data provided.

Technological Characteristics

Materials: Titanium alloy (ASTM F136). Design: Patient-specific CAD/CAM fabricated abutments. Interface: Internal conical connection with indexing (three grooves). Dimensions: 3.3-13 mm diameter, 4-15 mm height, 0-30° angulation. Connectivity: None. Sterilization: Same cycle as predicate.

Indications for Use

Indicated for partially or completely edentulous patients requiring prosthetic support via endosseous dental implants. Supports single or multiple tooth prostheses (cemented, screw-retained, or friction-fit) in the mandible or maxilla.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). 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.)

Predicate Devices

ATLANTIS™ Abutment for NobelActive 3.0 (K151039)
Osseospeed™ Profile EV (K130999)
CONELOG Implant System (K113779)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image. The logo is simple and recognizable, conveying the department's authority and purpose. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 26, 2016 Dentsply Sirona Ms. Helen Lewis Director Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404 Re: K161030 Trade/Device Name: ATLANTISTM Abutment for CONELOG Implant Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 27, 2016 Received: July 29, 2016 Dear Ms. Lewis: 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. {1}------------------------------------------------ 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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, Tina Kiang - 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K161030 Device Name ATLANTISTM Abutment for CONELOG implant ## Indications for Use (Describe) The ATLANTIS™ Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single tooth prosthesis, in mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment screw is intended to secure the ATLANTIS Abutment to the endosseous implant. The ATLANTIS™ Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTIS Crown Abutment to the endosseous implant. The ATLANTIS™ Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment screw is intended to secure the ATLANTIS Conus Abutment to the endosseous implant. ATLANTISTM products are compatible with the implants shown in the table below. | Implant Manufacturer | Trade Name | Implant Diameter | Abutment Platform Diameter | |----------------------|--------------------------------|------------------------|----------------------------| | Altatec GmbH | CONELOG SCREW- LINE Implant | Ø3.3, 3.8, 4.3, 5.0 mm | Ø3.3, 3.8, 4.3, 5.0 mm | Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404 Image /page/3/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized leaf-like shape in gray on the left, with a white stripe running through it. To the right of the leaf shape are the words "Dentsply" and "Sirona" stacked vertically, also in gray. The font is sans-serif and modern. # SECTION 5. 510(k) SUMMARY for # ATLANTISTM Abutment for CONELOG implant - 1. Submitter Information: Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404 | Contact Person: | Helen Lewis | |-------------------|--------------| | Telephone Number: | 717-487-1332 | | Fax Number: | 717-849-4343 | August 18, 2016 Date Prepared: - 2. Device Name: - Proprietary Name: - Classification Name: ● - CFR Number: ● - Device Class: . - Product Code: NHA . - 3. Predicate Device: | Predicate Device Name | 510(k) | Company Name | |-------------------------------------------------------------------------|---------|-----------------------------------------| | ATLANTIS™ Abutment for NobelActive 3.0 (Primary Predicate Device) | K151039 | DENTSPLY IMPLANTS MANUFACTURING GMBH | | Osseospeed™ Profile EV (Reference Predicate Device) | K130999 | DENTSPLY IMPLANTS MANUFACTURING GMBH | | CONELOG Implant System (Reference Predicate Device) | K113779 | Altatec GmbH | 21 CFR 872.3630 II ATLANTISTM Abutment for CONELOG implant Endosseous dental implant abutment - 4. Description of Device: The proposed ATLANTIS™ Abutment for CONELOG implant is an endosseous dental implant abutment. The subject device is provided for implant diameter (Ø3.3, 3.8, 4.3 and 5.0 mm) and three designs: ATLANTIS™ Abutment for CONELOG implant, ATLANTIS™ Crown Abutment for CONELOG implant and ATLANTIS™ Conus Abutment for CONELOG implant, see table 5-1. All are patient-specific abutments fabricated using CAD/CAM technology at DENTSPLY Implant sites. Each abutment is designed according to prescription instructions from the clinician to support a screwretained, cement-retained or friction fit prosthesis. {4}------------------------------------------------ Table 5-1: Compatibility table (The ATLANTIS Abutment Titanium and Gold-shaded are compatible with CONELOG implant interface (Ø3.3, 3.8, 4.3 and 5.0 mm) | Implant Manufacturer | Interface | ATLANTIS TM Abutment for CONELOG implant | ATLANTISTM Crown Abutment for CONELOG implant | ATLANTISTM Conus Abutment for CONELOG implant (Custom) | ATLANTISTM Conus Abutment for CONELOG implant (Overdenture) | |-------------------------|------------------------------------------------------------------------------------|------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------| | Altatec GmbH | CONELOG Implant System (SCREW- LINE) (Ø3.3, 3.8, 4.3 and 5.0 mm) | Titanium, Gold-shaded titanium (Gold-Hue) | Titanium | Titanium | Titanium | The coronal portion of the ATLANTIS™ Abutment can be fabricated as a conventional abutment for prosthesis attachment (ATLANTIS™ Abutment or ATLANTIS™ Conus Abutment) or fabricated as a single tooth final restoration onto which porcelain is added (ATLANTIS™ Crown Abutment). The ATLANTIS™ abutment interface is compatible with the CONELOG implants from the CONELOG Implant System (K113779). The CONELOG implant interface is an internal connection with indexing feature (three grooves) and provided for implant platform diameter (3.3, 3.8, 4.3 and 5.0 mm). The abutment diameter ranges from 3.3 to 13 mm, the maximum abutment height is 15 mm above implant interface and the minimum abutment height is 4 mm above the transmucosal collar. The abutment is provided straight and up to 30° of angulation. - న. Indications for Use: The ATLANTIS™ Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the ATLANTIS Abutment to the endosseous implant. The ATLANTIS™ Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTIS Crown Abutment to the endosseous implant. The ATLANTIS™ Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS Conus Abutment to the endosseous implant. {5}------------------------------------------------ ATLANTIS™ products are compatible with the implants shown in the table below. | Implant Manufacturer | Trade Name | Implant Diameter | Abutment Platform Diameter | |-------------------------|--------------------------------|------------------------|----------------------------| | Altatec GmbH | CONELOG SCREW- LINE Implant | Ø3.3, 3.8, 4.3, 5.0 mm | Ø3.3, 3.8, 4.3, 5.0 mm | - 6. Substantial Equivalence: Technological Characteristics ATLANTIS™ Abutment for CONELOG implant is a patient specific restorative device designed under the control of DENTSPLY and manufactured by DENTSPLY using CAD/CAM technology. Table 5-2 and 5-3 below summarizes the differences and similarities of the subject and predicate devices. {6}------------------------------------------------ Table 5-2: Indications for use for the proposed and the predicate devices | ATLANTISTM Abutment for CONELOG implant (Proposed | ATLANTISTM Abutment for NobelActive 3.0 | OsseoSpeed Profile EV (K130999) | CONELOG Implant System (K113779) | Summary of differences in the indications for use | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device) | (K151039) (Primary Predicate) | (Reference Predicate) | (Reference Predicate) | | | The ATLANTISTM Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the ATLANTIS Abutment to the endosseous implant. The ATLANTISTM Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTIS Crown Abutment to the endosseous implant. The ATLANTISTM Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS Conus Abutment to the endosseous implant. | The ATLANTISTM Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the ATLANTISTM Abutment to the endosseous implant. The ATLANTISTM Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTISTM Crown Abutment to the endosseous implant. The ATLANTISTM Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially | Implants: The ASTRA TECH Implant System – OsseoSpeed Profile EV implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols: Replacing missing teeth in single or multiple unit applications in the mandible or maxilla. Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge Especially indicated for us in soft bone applications where implants with other implant surface treatment may be less effective Immediate and early loading for all indications Together with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be | CONELOG® Implant System Implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. CONELOG® Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. CONELOG® Implants with Ø3.3 mm diameter have the following additional specific indications: These are an alternative in cases where the alveolar ridge width is only 5 - 6 mm. Because of their lower mechanical strength compared with larger diameter implants, they should only be used under the following conditions: As single implants, they should be used only to replace mandibular incisors and/or maxillary lateral incisors. An edentulous arch can only be restored with a bar retained superstructure with at least four implants of Ø3.3 mm diameter without distal extensions. Implants of Ø3.3 mm are suitable for a partially edentulous arch when | The indications for use of the proposed device are identical to the indications for use of the primary predicate device. The indications for use of the proposed device are similar to the indications for use of the reference predicate device (K130999). The difference is that the reference predicate device (K130999) also includes the indications for use of the implants, which is not the subject of this submission. The indications for use of the second reference predicate device cover the CONELOG implant system (K113779). The indications for use are similar. The difference between the proposed device and the reference predicate device (K113779) is that the prosthesis, in addition to screw-retained restoration or cement-retained restoration, can be attachment-retained (by friction-fit) to the proposed device. | {7}------------------------------------------------ ATLANTIS™ products are compatible with the implants shown in the table below. | Implant Manufacturer | Trade Name | Implant Diameter | Abutment Platform Diameter | |-------------------------|--------------------------------------|------------------------------|----------------------------------| | Altatec GmbH | CONELOG SCREW- LINE Implant | Ø3.3, 3.8, 4.3, 5.0 mm | Ø3.3, 3.8, 4.3, 5.0 mm | or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment retained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS™ Conus Abutment to the endosseous implant. ATLANTIS™ Abutment for NobelActive 3.0 is compatible with the NobelActive 3.0 implant. appropriate ● - Only together with Profile EV components, Implant Driver Profile EV, Radiographic Implant Guides Profile EV and non-Indexed prosthetic components ### Abutments: ASTRA TECH Implant System™-OsseoSpeed EV abutments are intended to be used in conjunction with ASTRA TECH Implant System™-OsseoSpeed EV in fully edentulous or partially edentulous maxillary and/or mandibular arches. ## The ATLANTISTM Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The ATLANTIS™ Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous patients. The prosthesis is combined with implants of larger diameter for splinted superstructures. However, the limited strength of the implants with Ø3.3 mm must be taken into account. - . Avoid excessive mechanical stressing of the implants when using ball abutments in combination with Ø3.3 mm implants. - . The healing time for Ø3.3 mm implants is at least 12 weeks. CONELOG® Implants with 7 mm length have the following additional specific indications: ### CONELOG® SCREW-LINE Implants should only be used when there is not enough space for a longer implant. Delayed loading in single tooth replacement is indicated with these implants. If the ratio of crown length to implant length is unfavorable the biomechanical risk factors have to be considered and appropriate measures have to be taken by the dental professional. {8}------------------------------------------------ | | screw retained. The abutment screw is intended to secure the ATLANTIS™ Abutment to the endosseous implant. The ATLANTIS Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS Abutment to the endosseous implant. ATLANTISTM Abutment, ATLANTIS™ Crown Abutment and ATLANTISTM Conus Abutment are compatible with ASTRA TECH Implant System Profile EV | | |--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| |--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| {9}------------------------------------------------ Table 5-3: Similarities and differences between the proposed and the predicate devices | Element | Proposed Device ATLANTISTM Abutment for CONELOG implant | Primary Predicate Device ATLANTISTM Abutment for NobelActive 3.0 | Reference Predicate Device OsseoSpeed Profile EV | Reference Predicate Device CONELOG Implant System | Summary of differences | |-------------------------------|------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) | To be assigned | K151039 | K130999 | K113779 | - | | Prosthesis Attachment | Screw-retained Cement-retained Friction Fit | Screw-retained Cement-retained Friction Fit | Screw-retained Cement-retained Friction Fit | Screw-retained Cement-retained | No difference between the proposed device and the primary predicate and the reference device (K130999). | | Restoration | Single or Multi-unit | Single or Multi-unit | Single or | Single or Multi-unit | No difference. | | Abutment Platform Diameter | 3.3, 3.8, 4.3, 5.0 | 3.0 | 3.0, 4.2, 4,8 | 3.3, 3.8, 4.3, 5.0 | The proposed abutment platform is designed to fit the reference predicate device (K113779). The proposed device encompasses the same range of physical dimensions; diameter, height and angle of abutments for the primary predicate as for the reference predicate (K113779). The subject abutment platform is not designed to fit the primary predicate device (K151039) or the reference predicate device (K130999). | | Abutment angle | Straight, up to 30° | Straight, up to 30° | Straight, up to 30° | Straight, up to 30° | No difference. | | Element | Proposed Device ATLANTISTM Abutment for CONELOG implant | Primary Predicate Device ATLANTISTM Abutment for NobelActive 3.0 | Reference Predicate Device OsseoSpeed Profile EV | Reference Predicate Device CONELOG Implant System | Summary of differences | | Connection | Internal conical connection | Internal conical connection | Internal conical connection | Internal conical connection | The internal conical connection is similar for the proposed device when compared to the primary predicate device (K151037) or the reference predicate device (K130999). The connection of the proposed device is designed to fit the reference predicate (K113779). | | Material Implant | NA | NA | Titanium | Titanium | The proposed device and primary predicate is an abutment. | | Material: Abutment | Titanium alloy | Titanium alloy | Titanium alloy | Titanium alloy | No difference. | | Material: Screw | Titanium alloy | Titanium alloy | Titanium alloy | Titanium alloy | No difference. | {10}------------------------------------------------ {11}------------------------------------------------ #### 7. Biocompatibility The results of biocompatibility testing conducted for the primary predicate device, ATLANTIS™ Abutment for NobelActive 3.0 (K151039), are valid because the material composition of the proposed device is the same when compared to the primary predicate device, ATLANTISTM Abutment for NobelActive 3.0 (K151039). Atlantis abutments are made of titanium allov conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4Vandadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). As per our biological evaluations on the titanium materials used for the ATLANTIS Abutment (RP-00054490), the following tests were performed: Cytotoxicity, Sensitization, Irritation of Intracutaneous reactivity, Acute systemic toxicity, Subchronic toxicity, Genotoxicity - AMES, and Hemolysis. Since the material composition of the proposed devices is identical to the predicate devices, the result of referenced biocompatibility testing is still valid. Therefore, no additional biocompatibility testing has been performed. #### Sterility 8. The sterility testing conducted for the primary predicate device, ATLANTIS™ Abutment for NobelActive 3.0 (K151039), was conducted with the same materials and same sterilization cycle. Therefore, no additional sterility testing was required for the proposed device, ATLANTIS™ Abutment for CONELOG implant. #### 9. Non-Clinical Performance Data Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence includes mechanical design analysis, dimensional analysis, and static and dynamic compression-bending testing according to ISO 14801 Dental-implants Dynamic Fatigue Test for Endosseous Dental Implants. Compatibility analysis shows that the ATLANTIS™ Abutment for CONELOG implant is compatible with the (3.3, 3.8, 4.3 and 5.0 mm) CONELOG implants. Mechanical testing results show that the ATLANTIS™ Abutment for CONELOG implant has sufficient strength for its intended use. # 9. Conclusion Regarding Substantial Equivalence The ATLANTIS™ Abutment for CONELOG implant is an endosseous dental implant abutment which is intended to support a prosthetic device in a partially or completely edentulous patient. The ATLANTIS™ Abutment for CONELOG implant has the same intended use, incorporates the same fundamental technology, and has similar indications for use as the predicates ATLANTIS™ Abutment for NobelActive 3.0 (K151039), Osseospeed Profile EV (K130999) and CONELOG Implant System (K113779). Test data to verify the performance of the ATLANTIS™ Abutment for CONELOG implant has been provided including: mechanical testing and compatibility analysis. The results of this testing, combined with the design, and intended use comparison with the predicate devices, support substantial equivalence.

ATLANTIS Abutment for CONELOG implant

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ATLANTIS Abutment for CONELOG implant

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