The OsseOne Dental Implant System implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. OsseOne Dental implants are intended for single or multiple unit restorations on splinted or non-splinted applications. OsseOne Dental implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period.

Device Description

The OsseOne Dental Implant System contains 1 design of internal hex implant and a multipurpose indexed hex abutment as described below as well as 3 designs of conical implant with NP and RP platforms and abutments corresponding to both platforms. All devices are made from ASTM F136 Ti-6AL-4V ELI unless otherwise noted. The implants have a grit blasted and acid etched surface. Conical abutments need to match the implant platform of narrow or regular. No abutments are intended to be modified by the user other than the multipurpose indexed abutments & tapered multipurpose abutments which can be reduced in height to a minimum of 6mm above the platform. Multipurpose indexed abutments & tapered multi-purpose abutments are not intended for angular correction and are not intended to be cast.

OsseoMax Hex implants are tapered internal hex implants with evenly spaced large threads the length of the implant. OsseoMax Hex comes in 4.6, and 5.4 mm diameter with lengths of 8, 10mm. OsseoMax Hex are only restored using hex ball attachments or Denture Lock hex cleared in K182293.

Tapered Multipurpose Indexed Hex Abutments have a 3.75mm platform diameter with a total height of 10.98mm. Height above the platform is 7.58mm. Tapered Multipurpose Indexed Hex Abutments are to be used with internal hex implant designs cleared in K182293 and are not to be used with OsseoMax Hex.

OsseoCone implants are slightly tapered conical implants with evenly spaced sharp edge threads with microthreads in between them as well as microgrooves in the collar. OsseoCone comes in NP (3.5mm), and RP (4.3, 5.0, and 5.5mm) in lengths of 8.5, 10, 11.5, 13 and 15mm.

OsseoCone Plus implants are very slightly tapered conical implants with more tightly spaced flat edge threads at the top and wider spaced sharp edge threads in the lower tapered section. OsseoCone Plus comes in 3.5 (NP), 4.3 (RP), 5.0 (RP) and, 5.5 (RP) mm diameter with lengths of 8, 10, 11.5, 13, and 16 mm (no 5.5 x 16mm).

OsseoMax Conical implants tapered conical implants with evenly spaced large threads the length of the implant. OsseoMax Conical comes in 4.6 and 5.4 RP diameter with lengths of 8, 10mm. OsseoMax Conical are only restored using Conical ball attachments or Conical Denture Lock.

Conical healing caps come in NP and RP (3.75 and 4.5 mm diameter) with cuff heights (also height above gingiva) of 2,3,4,5 mm. Total heights are 7.32, 8.32, 9.32, 20.32 mm and 7.47, 8.47, 9.47, 10.47mm. NP and RP conical cover screws are also available. A healing cap for multi-units is available.

Conical straight abutments in 4.5mm diameter come in NP and RP with heights above gingiva of 7.7, 10.7 and 6.1, 8.3mm. Total heights are 11.85, 15.9mm and 10.6, 13mm.

Conical anatomic abutments in 4.5mm diameter come in NP and RP with gingival heights of 1,2,3 mm. Height above the platform is 7.5mm. Total heights are 11.8, 12.6, 13.6mm for both NP and RP versions.

Conical angled anatomic abutments in 5mm diameter come in 15° and 25° NP with shoulder cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm. Height above platform is 7.6mm.

Conical angled anatomic abutments in 5mm diameter come in 15° and 25° RP with shoulder cuff heights of 1,2,3,4 mm and total heights of 11, 12, 13, 14 mm. Height above platform is 8.4mm.

Multipurpose Indexed Conical abutment comes in NP, RP, and RP Wide with platform diameters of 4.2, 4.2 and 4.7 mm Total heights are 11.69, 11.33 and 11.33 mm. Height above platform is 8.29, 7.93, 7.93mm. Multipurpose Indexed Conical abutments are to be used with the conical implants listed above but are not to be used with OsseoMax Conical Implants.

Conical ball attachments come in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4,5,6 mm. Total heights are 9.5, 10.5, 11.5, 12.5, 13.5, 14.5mm and 9.45, 10.45, 11.45, 12.45, 13.45, 14.45mm. Height above the platform is 3.47, 4.47, 5.47, 6.47, 7.47, 8.47mm and 4, 5, 6, 7, 8, 9mm.The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place. The housing and retention caps were cleared in K182293.

Conical Denture Lock attachments come in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4 mm. Total heights are 8.95, 9.95, 10.95, 11.95mm and 8.7, 9.7, 10.7, 11.7mm. Height above the gingiva is 2.3, 3.3, 4.3, 5.3mm. The Denture Lock attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place. The housing and retention caps were cleared in K182293.

Conical straight multi-units in NP and RP are 4.8mm in diameter with cuff heights of 1,2,3,4,5 mm. Height above platform is 3.6, 4.6, 5.6, 6.6, 7.6mm. Total heights are 9.1, 10.1, 11.1, 12.1, 13.1mm and 9.25, 10.25, 11.25, 12.25, 13.25mm.

Conical NP and RP Angled Multi-Units are 4.8mm in diameter and come in 17° and 30° with cuff heights of 1, or 2 mm. Cone height above platform 2.15mm. NP total heights are 6.35, 7.35mm and 6.85, 7.85mm. RP total heights are 6.75, 7.11mm and 7.15, 8.15mm.

Conical abutment screws in NP & RP are used with conical abutments including angled multi-units.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for the "OsseOne Dental Implant System" does not contain information typically found in an AI/software as a medical device (SaMD) submission regarding acceptance criteria, study design, and performance metrics for an AI-powered diagnostic device.

This document describes a dental implant system, which is a physical device used in surgery, not a software or AI-driven diagnostic tool. Therefore, the questions related to AI performance, human reader improvement with AI, ground truth establishment for AI models, and training/test set sizes for AI are not applicable to this submission.

The "Testing Summary" section primarily discusses non-clinical physical performance and biocompatibility testing for the dental implant components.

Here's a breakdown of the relevant information found in the document, framed as closely as possible to your request for acceptance criteria and study details, acknowledging the nature of the device:

OsseOne Dental Implant System - Acceptance Criteria and Study Overview

This FDA 510(k) clearance pertains to a physical medical device, the OsseOne Dental Implant System, and not an AI or software-based diagnostic tool. Therefore, the acceptance criteria and study details focus on the mechanical and biological aspects of the implant system rather than AI performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit "acceptance criteria" in a quantitative performance table typical for AI/diagnostic devices. Instead, it states that the device was tested to demonstrate safety and effectiveness for its intended use, primarily through non-clinical laboratory testing. The reported performance is summarized qualitatively.

Category	Acceptance Criterion (Implicit/Derived)	Reported Device Performance
Mechanical Strength	Sufficient run-out load for intended use (based on ISO 14801).	"Sufficient run out load for their intended use"
Biocompatibility	Non-cytotoxic, non-sensitizing, non-irritating (based on ISO 10993).	Biocompatibility testing leveraged from predicate (K182293) and new tests conducted for cytotoxicity, skin sensitization, and irritation, all within specified limits/standards.
Sterilization	Validated steam and gamma sterilization processes.	Steam sterilization validated per ISO 17665-1. Gamma irradiation validated per ISO 11137-2.
Material Composition	Conformance to ASTM F136 Ti-6AL-4V ELI (unless otherwise noted).	All devices made from ASTM F136 Ti-6AL-4V ELI unless otherwise noted.
Surface Treatment	Cleanliness demonstrated post-treatment.	"Post Surface Treatment Cleanliness Demonstrated: Yes", with testing for organic carbon, hydrocarbons, and SEM/EDX.
Packaging & Shelf-Life	Validated packaging integrity and shelf-life.	Tests relating to gamma validation, packaging, and shelf-life from K182293 leveraged. New packaging tests conducted per ASTM D999-08, ASTM F3039-13, ASTM D5276-98(2009), followed by shelf-life testing per ASTM F1929-12, ASTM F1980-07.
Bacterial Endotoxin	Conformance to limits for bacterial endotoxin.	Bacterial endotoxin testing conducted per ANSI/AAMI ST72:2019 and USP <161>, results within limits.
MRI Safety	Acceptable magnetically induced displacement force and torque.	Non-clinical worst-case MRI review performed using scientific rationale and published literature, addressing relevant parameters per FDA guidance.

2. Sample Size for Test Set and Data Provenance

For this physical device, there isn't a "test set" of patient data in the way an AI diagnostic device would have. The "samples" refer to the physical implant components tested in various laboratory conditions.

Sample Size for Testing: Not explicitly stated as a number of implants/abutments for each test. The summary mentions "Dynamic fatigue testing according to ISO 14801 was conducted," "Biocompatibility testing...was done," "Steam sterilization validation was conducted," etc. ISO standards typically prescribe minimum sample sizes for such tests.
Data Provenance: Not applicable in terms of retrospective/prospective patient data or country of origin for patients. The data provenance is from laboratory testing performed by the manufacturer or contract labs.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. "Ground truth" in the context of an FDA 510(k) for a physical device like a dental implant is established through adherence to recognized international standards (e.g., ISO, ASTM), material specifications, and validated engineering principles. There are no "experts establishing ground truth" on a test set of cases in the diagnostic sense. The experts are the engineers, material scientists, and microbiologists who perform and interpret the laboratory tests according to established protocols.

4. Adjudication Method for Test Set

Not applicable. This concept pertains to resolving discrepancies in expert interpretations of diagnostic data, which is not relevant for physical device performance testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This type of study is specific to evaluating the clinical effectiveness of AI-assisted diagnostic tools by comparing human reader performance with and without AI assistance. The OsseOne Dental Implant System is a physical implant, not a diagnostic aid.

6. Standalone Performance (Algorithm Only)

Not applicable. There is no AI algorithm in this device. The system is a physical dental implant.

7. Type of Ground Truth Used

For this physical medical device, the "ground truth" is established through:

Engineering Standards: Conformance to mechanical test standards (e.g., ISO 14801 for fatigue).
Biocompatibility Standards: Conformance to biological safety standards (e.g., ISO 10993 for cytotoxicity, sensitization, irritation).
Material Specifications: Verification that components meet specified material requirements (e.g., ASTM F136 Ti-6AL-4V ELI).
Sterilization Validation: Demonstrated effectiveness of sterilization processes (e.g., ISO 17665-1, ISO 11137-2).

8. Sample Size for the Training Set

Not applicable. There is no training set as this is not an AI/machine learning device. The design and manufacturing processes are validated through engineering and biological testing, not through training on data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Summary

FDA 510(k) Clearance Letter - OsseOne Dental Implant System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

Synoross DBA OsseOne
℅ Angela Blackwell
Senior Consultant
Blackwell Device Consulting
P.O. Box 718
Gresham, Oregon 97030-0172

Re: K233271
Trade/Device Name: OsseOne Dental Implant System
Regulation Number: 21 CFR 872.3640
Regulation Name: Endosseous Dental Implant
Regulatory Class: Class II
Product Code: DZE, NHA
Dated: April 8, 2025
Received: April 9, 2025

Dear Angela Blackwell:

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 (the 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 available 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.

May 8, 2025

Page 2

Synoross DBA OsseOne
℅ Angela Blackwell
Senior Consultant
Blackwell Device Consulting
P.O. Box 718
Gresham, Oregon 97030-0172

May 8, 2025

Dear Angela Blackwell:

K233271 - Angela Blackwell Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

Page 3

K233271 - Angela Blackwell Page 3

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-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

Andrew I. Steen
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below

510(k) Number (if known): K233271
Device Name: OsseOne Dental Implant System

Indications for Use (Describe):

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."

FORM FDA 3881 (8/23) Page 1 of 1

Page 5

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below

510(k) Number (if known): K233271
Device Name: OsseOne Dental Implant System

Indications for Use (Describe):

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.

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."

FORM FDA 3881 (8/23) Page 1 of 1

Page 6

510k Summary

May 6, 2025
OsseOne Dental Implant System
K233271

Name and address: OsseOne
330 N. Central Ave
Glendale, CA 91203

Contact Person: Gene Shapiro
Phone Number: (310) 980-3632
Email: gene.shapiro@gmail.com

Name of device: OsseOne Dental Implant System
Classification Name: Endosseous dental implants
CFR: 21 CFR 872.3640
Primary Product Code: DZE
Secondary Product Code: NHA
Regulatory Classification: II

Submission Contact:
Angela Blackwell
Blackwell Device Consulting
P.O. Box 718
Gresham, OR 97030-0172
(704)450-9934
angela@blackwelldevice.com

Device Description: The OsseOne Dental Implant System contains 1 design of internal hex implant and a multipurpose indexed hex abutment as described below as well as 3 designs of conical implant with NP and RP platforms and abutments corresponding to both platforms. All devices are made from ASTM F136 Ti-6AL-4V ELI unless otherwise noted. The implants have a grit blasted and acid etched surface. Conical abutments need to match the implant platform of narrow or regular. No abutments are intended to be modified by the user other than the multipurpose indexed abutments & tapered multipurpose abutments which can be reduced in height to a minimum of 6mm above the platform. Multipurpose indexed abutments & tapered multi-purpose abutments are not intended for angular correction and are not intended to be cast.

Page 7

Conical straight abutments in 4.5mm diameter come in NP and RP with heights above gingiva of 7.7, 10.7 and 6.1, 8.3mm. Total heights are 11.85, 15.9mm and 10.6, 13mm.

Conical anatomic abutments in 4.5mm diameter come in NP and RP with gingival heights of 1,2,3 mm. Height above the platform is 7.5mm. Total heights are 11.8, 12.6, 13.6mm for both NP and RP versions.

Conical angled anatomic abutments in 5mm diameter come in 15° and 25° NP with shoulder cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm. Height above platform is 7.6mm.

Conical angled anatomic abutments in 5mm diameter come in 15° and 25° RP with shoulder cuff heights of 1,2,3,4 mm and total heights of 11, 12, 13, 14 mm. Height above platform is 8.4mm.

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and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place. The housing and retention caps were cleared in K182293.

Conical abutment screws in NP & RP are used with conical abutments including angled multi-units.

Indications for Use:

Testing Summary: Dynamic fatigue testing according to ISO 14801 was conducted to determine the abutments and implants are strong enough for their intended use. Biocompatibility testing from K182293 is being leveraged for the abutments and implants in this submission. Cytotoxicity testing according to ISO 10993 was done on both implants and abutments. Skin sensitization testing according to ISO 10993-10:2021 was conducted on implants. Irritation testing according to ISO 10993-23:2021 was conducted on implants. Steam sterilization validation was conducted according to ISO 17665-1. Tests relating to gamma validation, packaging and shelf life from K182293 are leveraged for the tests listed. Bacterial endotoxin testing was conducted according to ANSI/AAMI ST72:2019 and USP <161>. Gamma irradiation validation was conducted according to ISO 11137-2. Package testing was conducted according to ASTM D999-08, ASTM F3039-13, and ASTM D5276-98(2009) and then shelf life testing was conducted according to ASTM F1929-12, and ASTM F1980-07. Testing of the modified surface included testing for organic carbon, hydrocarbons, and SEM/EDX. All were within the limits based on relevant standards set in the cleaning validation protocol.

MR Environment Condition

Page 9

Non-clinical worst-case MRI review was performed to evaluate the metallic OsseOne Dental Implant System devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.

Primary Predicate Device: OsseoPlus and OsseoLock from OsseOne Dental Implant Systems K182293
Reference Predicates: TOV Dental Implant System K240837 Surgikor Dental Implant System K182615

Substantial Equivalence:

The OsseOne Dental Implant System is substantially equivalent to the previous version of the OsseOne Dental Implant System in indications for use, and materials including surface treatment and substantially equivalent to TOV Dental Implant System and Surgikor Dental Implant System in design, and fatigue performance. Slight differences in implant and abutment design between the subject devices and the predicate devices were addressed by showing both had adequate fatigue performance.

Company & Device Name	OsseOne Dental Implant System Subject Device	OsseoPlus and OsseoLock from OsseOneDental Implant System K182293 Predicate Device	Surgikor's Dental Implant System K182615 Reference Device	TOV Dental Implant System K240837 Reference Device
Indications for Use	The OsseOne Dental Implant System implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. OsseOne Dental implants are intended for	OsseOne Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. OsseOne implants are intended for single or multiple	Surgikor's Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Dental Implant System is indicated also for	The TOV Dental Implant System are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. Implanet implants are

Page 10

| | single or multiple unit restorations on splinted or non-splinted applications. OsseOne Dental implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period. | unit restorations on splinted or non-splinted applications. OsseoPlus and OsseoLock are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period. OsseoLock 3.3 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.3 implants adjacent to one another. | immediate loading when good primary stability is achieved and with appropriate occlusal loading. The 7mm implants are intended to be used in the molar region. | intended for single or multiple unit restorations on splinted or non-splinted applications. Maer, Ragil and TCX are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period. Ragil 3.3 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.3 implants adjacent to one another. |
| Implant Diameters | OsseoCone NP 3.5mm RP 4.3, 5.0, 5.5 mm OsseoCone Plus NP 3.5mm RP 4.3, 5.0, 5.5 mm OsseoMax Conical 3.5 NP, 4.2 RP and Hex 3.5, 4.2 mm | OsseoLock 3.3, 3.75, 4.2, 5.0, 6.0mm OsseoPlus 3.5, 3.75, 4.2, 5.0, 6.0mm | Fixation Narrow Platform 3.0mm Fixation Regular Platform 3.5, 3.9mm Fixation Wide Platform 4.3, 5.0mm Solution5 Narrow Platform 3.25mm | Maer 3.5, 3.75, 4.2, 5.0, 6.0 mm Ragil 3.3, 3.75, 4.2, 5.0, 6.0 mm TCX 3.5, 4.3, 5.0 mm NP = 3.5 RP = 4.3, 5.0 |

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| | | | Solution5 Regular Platform 3.5, 4.0mm Solution5 Wide Platform 4.5, 5.0, 5.5, 6.0mm Solution2 3.25mm | |
| Implant Lengths | OsseoCone 8.5, 10, 11.5, 13, 15mm OsseoCone Plus 8.5, 10, 11.5, 13, 16mm (no 5.5 x 16mm) OsseoMax Conical and Hex 8, 10 mm | 8, 10, 11.5, 13, 16 (OsseoLock 5.0 and 6.0 not in 16mm) | Fixation Narrow Platform 10, 11.5, 13, 15mm Fixation Regular Platform 8.5, 10, 11.5, 13, 15, 18mm Fixation Wide Platform 8.5, 10, 11.5, 13, 15, 18mm Solution5 Narrow Platform 10,11.5, 13, 15mm Solution5 Regular Platform 7.0 (4.0 diameter only), 8.5, 10, 11.5, 13, 15mm Solution5 Wide Platform 7.0, 8.5, 10, 11.5, 13, 15mm Solution2 10, 11.5,13 16mm | Maer 8, 10, 11.5, 13,16mm (no 16mm in 6.0mm diameter) Ragil 8, 10, 11.5, 13, and 16mm (no 16mm in 5.0 or 6.0mm diameter) TCX 8, 10, 11.5, 13,16mm |
| Material of devices included in the submission | Ti-6AL-4V ELI | Ti-6AL-4V ELI | Ti-6AL-4V ELI | Ti-6AL-4V ELI |
| Interface type/shape | Internal hex, conical | Internal hex | conical | Internal hex, conical |
| ISO 14801 Fatigue Testing | Sufficient run out load for their intended use | Sufficient run out load for their intended use | Sufficient run out load for their intended use | Sufficient run out load for their intended use |

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Implant Lengths	OsseoCone 8.5, 10, 11.5, 13, 15mm OsseoCone Plus 8.5, 10, 11.5, 13, 16mm (no 5.5 x 16mm) OsseoMax Conical and Hex 8, 10 mm	8, 10, 11.5, 13, 16 (OsseoLock 5.0 and 6.0 not in 16mm)	Fixation Narrow Platform 10, 11.5, 13, 15mm Fixation Regular Platform 8.5, 10, 11.5, 13, 15, 18mm Fixation Wide Platform 8.5, 10, 11.5, 13, 15, 18mm Solution5 Narrow Platform 10,11.5, 13, 15mm Solution5 Regular Platform 7.0 (4.0 diameter only), 8.5, 10, 11.5, 13, 15mm Solution5 Wide Platform 7.0, 8.5, 10, 11.5, 13, 15mm Solution2 10, 11.5,13 16mm	Maer 8, 10, 11.5, 13,16mm (no 16mm in 6.0mm diameter) Ragil 8, 10, 11.5, 13, and 16mm (no 16mm in 5.0 or 6.0mm diameter) TCX 8, 10, 11.5, 13,16mm
Material of devices included in the submission	Ti-6AL-4V ELI	Ti-6AL-4V ELI	Ti-6AL-4V ELI	Ti-6AL-4V ELI
Interface type/shape	Internal hex, conical	Internal hex	conical	Internal hex, conical
ISO 14801 Fatigue Testing	Sufficient run out load for their intended use	Sufficient run out load for their intended use	Sufficient run out load for their intended use	Sufficient run out load for their intended use

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Surface Treatment	SLA	SLA	HA blasted and double acid etched	SLA
Post Surface Treatment Cleanliness Demonstrated	Yes	Yes	Yes	Yes

	OsseOne Dental Implant System (This submission)	OsseoPlus and OsseoLock from OsseOne Dental Implant System K182293	Surgikor Dental Implant System K182615	TOV Dental Implant System K240837
Cover screw	Cover screw for NP and RP	Cover Screw for IH	Cover screws NP and RP	Cover screws for NP and RP
Multi-Unit Abutments in NP and RP	4.8 mm diameter multi-units in NP and RP with cuff heights of 1,2,3,4,5mm. Height above platform is 3.6, 4.6, 5.6, 6.6, 7.6mm. Total heights are 9.1, 10.1, 11.1, 12.1, 13.1mm and 9.25, 10.25, 11.25, 12.25, 13.25mm.	4.5 mm multi-unit abutments in heights of 1,2,3 and 4 mm	5.00 mm multiunit abutments in heights of 1,2,3 and 4 mm	4.8 mm diameter multi-units in NP and RP with cuff heights of 1,2,3,4,5mm. Height above platform is 3.6, 4.6, 5.6, 6.6, 7.6mm. Total heights are 9.1, 10.1, 11.1, 12.1, 13.1mm and 9.25, 10.25, 11.25, 12.25, 13.25mm.
17° and 30° Angled Multi-Unit Abutments	NP and RP 17° and 30° Angled Multi-Unit Abutments NP and RP with platform heights of 1,2 mm Cone height above platform 2.15mm. NP total heights are 6.35, 7.35mm and 6.85, 7.85mm. RP total heights are 6.75, 7.11mm and 7.15, 8.15mm.	17° and 30° overdenture abutments in heights of 1,2, and 3 mm	18° and 30° Multiunit abutments in platform heights of 1,2,3 and 4 mm	17° and 30° Angled Multi-Unit Abutments NP and RP with platform heights of 1,2 mm Cone height above platform 2.15mm. NP total heights are 6.35, 7.35mm and 6.85, 7.85mm. RP total heights are 6.75, 7.11mm and 7.15, 8.15mm.

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Locator Abutments with metal housing and retention cap allowing 20° divergence of the implants	Conical Denture Lock attachments NP and RP (3.9mm) Cuff heights of 1, 2, 3, 4, mm Total heights are 8.95, 9.95, 10.95, 11.95mm and 8.7, 9.7, 10.7, 11.7mm. Height above the gingiva is 2.3, 3.3, 4.3, 5.3mm. Ti6Al4V ELI housing Polyamide, polyether or polyoxymethylene retention cap with retention levels from 0.6to 1.5 kg Housing and retention cap cleared in K182293.	Denture Lock attachments 3.85mm diameter in cuff heights of 1,2,3,4, 5, and 6 mm Ti6AL4V ELI housing Polyamide, polyether or polyoxymethylene retention cap with retention levels from 0.6to 1.5 kg	3.85mm diameter Locator abutments in heights of 1,2,3,4,5, and 6mm Ti6AL4V ELI housing Polyamide, polyether or polyoxymethylene retention cap with retention levels from 0.6to 1.5 kg	Conical Retentor attachments NP and RP (3.9mm) Cuff heights of 1, 2, 3, 4, mm Total heights are 8.95, 9.95, 10.95, 11.95mm and 8.7, 9.7, 10.7, 11.7mm. Height above the gingiva is 2.3, 3.3, 4.3, 5.3mm. Ti6Al4V ELI housing Polyamide, polyether or polyoxymethylene retention cap with retention levels from 0.6to 1.5 kg Housing and retention cap.
Ball attachments with metal housing and retention cap allowing 14° divergence of the implants	Conical ball attachments NP (3.5mm diameter) and RP (5.0mm diameter) Cuff heights of 1,2,3,4,5,6 mm for NP and RP Total heights are 9.5, 10.5, 11.5, 12.5, 13.5, 14.5mm and 9.45, 10.45, 11.45, 12.45, 13.45, 14.45mm. Height above the platform is 3.47, 4.47, 5.47, 6.47, 7.47, 8.47mm and 4, 5, 6, 7, 8, 9mm.	4.00 mm Ball attachments in platform heights of 2,3,4,5, and 6mm Stainless steel 316 housing Polyamide or polyether retention cap with retention levels from 0.5 to 1.3 kg	4.1 mm Ball attachments in heights of 1,2,3,4,5, and 6mm Polyamide or polyether retention cap with retention levels from 0.5 to 2.7 kg	Conical ball attachments NP (3.5mm diameter) and RP (5.0mm diameter) Cuff heights of 1,2,3,4,5,6 mm for NP and RP Total heights are 9.5, 10.5, 11.5, 12.5, 13.5, 14.5mm and 9.45, 10.45, 11.45, 12.45, 13.45, 14.45mm. Height above the platform is 3.47, 4.47, 5.47, 6.47, 7.47, 8.47mm and 4, 5, 6, 7, 8, 9mm.

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	Stainless steel 316 housing Polyamide or polyether retention cap with retention levels from 0.5 to 1.3 kg Housing and retention caps cleared in K182293.			Stainless steel 316 housing Polyamide or polyether retention cap with retention levels from 0.5 to 1.3 kg Housing and retention caps.
Healing Caps 3.8mm	3.75 diameter NP healing cap in 2,3,4,5 mm (also height above gingiva) cuff heights Total heights are 7.32, 8.32, 9.32, 20.32 mm..	3.8mm diameter Healing Cap in 3,4,5,6,7 mm platform height		3.75 diameter NP healing cap in 2,3,4,5 mm (also height above gingiva) cuff heights Total heights are 7.32, 8.32, 9.32, 20.32 mm..
Healing Caps 4.5 diameter standard	4.5 mm diameter RP healing cap with cuff heights 2,3,4,5 mm (also height above gingiva). Total heights are 7.47, 8.47, 9.47, 10.47mm.	4.5mm diameter Healing cap in 2,3,4,5,6, and 7mm platform height	4.5mm diameter Healing cap in 2,3,4,5,6mm platform height	4.5 mm diameter RP healing cap with cuff heights 2,3,4,5 mm (also height above gingiva). Total heights are 7.47, 8.47, 9.47, 10.47mm.
Standard Titanium Abutment	NP and RP 4.5mm diameter with heights above gingiva of 7.7, 10.7 and 6.1, 8.3mm. Total heights are 11.85, 15.9mm and 10.6, 13mm.	4.9mm Nonshouldered Standard Titanium Abutment with heights of 5,7, 9, 12, and 15 mm		NP and RP 4.5mm diameter with heights above gingiva of 7.7, 10.7 and 6.1, 8.3mm. Total heights are 11.85, 15.9mm and 10.6, 13mm
Standard Shoulder Abutment	4.5 diameter NP, RP anatomic abutment with shoulder heights of 1,2,3 mm Height above the platform is	4.5mm diameter Standard Wide Shoulder Abutment with heights of 1,2,3,4 mm and total heights of 10.9,	4.3mm diameter Standard Wide Shoulder Abutment with heights of 1,2,3, and 4mm and total heights of	4.5 diameter NP, RP anatomic abutment with shoulder heights of 1,2,3 mm Height above the platform is 7.5mm. Total heights are

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	7.5mm. Total heights are 11.8, 12.6, 13.6mm for both NP and RP versions.	11.9, 12.9, 13.9 mm 5.4mm diameter Standard Wide shoulder abutment with shoulder heights of 1.2.3 mm and total heights of 10.7, 11.7 and 12.7mm	9.5, 10.5, 11.5, 12.5 mm 6.9mm diameter wide emergence abutment total heights of 5,7,9,12,15 mm	11.8, 12.6, 13.6mm for both NP and RP versions.
Shouldered Standard 15° Abutment	NP RP Diameter 5.00 NP and RP 15° Angled Anatomic Abutment with cuff heights of 1,2,3 mm and total heights of 10.7, 12.2 and 13.7 mm & 11, 12, 13, 14 mm Height above platform is 7.6mm NP and 8.4mm RP.	3.75mm diameter 15° Angled Shoulder Abutment with cuff heights of 1,2,3 mm and height above low side of shoulder 8,9,10 mm	3.75mm diameter Anatomic Shouldered Standard 15° Abutment with collar heights of 1,2, or 3mm	Diameter 5.00 NP and RP 15° Angled Anatomic Abutment with cuff heights of 1,2,3 mm and total heights of 10.7, 12.2 and 13.7 mm & 11, 12, 13, 14 mm Height above platform is 7.6mm NP and 8.4mm RP.
Shouldered Standard 25° Abutment NP RP	Diameter 5.00 NP and RP 25° Angled Anatomic Abutment with cuff heights of 1,2,3 mm with total heights of 10.7, 12.2, and 13.7 mm & 11, 12, 13, 14 mm Height above platform is 7.6mm NP and 8.4mm RP.	3.75mm diameter 25° Angled Shoulder Abutment with cuff heights of 1,2,3 mm with heights above platform of 8.3,9.2,10.3 mm	3.75mm diameter Anatomic Shouldered Standard 25° Abutment with collar heights of 1,2, or 3mm	Diameter 5.00 NP and RP 25° Angled Anatomic Abutment with cuff heights of 1,2,3 mm with total heights of 10.7, 12.2, and 13.7 mm & 11, 12, 13, 14 mm Height above platform is 7.6mm NP and 8.4mm RP.
Indexed Shouldered Abutment	Tapered Multipurpose Indexed Hex Abutments IH with a diameter of	4.3mm diameter Standard Wide Shoulder Abutment with heights of 1,2,3,

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| | 3.75mm and total height of 10.98mm, with platform width 3.75mm and height above platform of 7.58mm. Multipurpose Indexed Conical Abutment NP, RP, RP Wide with diameters of 3.00, 3.4, 3.4mm and total heights of 11.69, 11.33, 11.33 mm. Platform width 4.2, 4.2, 4.7 mm Height above platform 8.29, 7.93, 7.93mm. | and 4mm and total heights of 9.5, 10.5, 11.5, 12.5 mm 6.9mm diameter wide emergence abutment total heights of 5,7,9,12,15 mm | | |

Conclusion:

OsseOne Dental Implant System is substantially equivalent to OsseoPlus and OsseoLock from the OsseOne Dental Implant System. They both have similar indications for use and are of the same material. The abutments, healing caps, and angled abutments are offered in similar designs and heights to TOV Dental Implant System. Surgikor Dental Implant System has conical connection implants like OsseOne Dental Implant System. Any abutment designs not found within the TOV Dental Implant System were found in the reference devices which have the same materials, similar indications for use and same conical connections as the OsseOne Dental Implant System. Performance testing demonstrates substantial equivalence to the identified predicate devices.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
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.(b)
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.