The Osteon Precision Milled Suprastructure is indicated for attachments in the treatment of partially or fully edentulous jaws for the purpose of restoring function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.

The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems:

· Astra Tech Implant System® Multi Base Abutment EV, 4.8mm, max 30°
· BioHorizons Multi Unit Abutment, 4.8mm, max 30°
- · CONELOG® Implant System
· Biomet 3 i Multi Unit Abutments, 4.8mm, max 30°
- · TSXTM Implants
- · Tapered Screw-Vent Implant
· DESS Dental Multi Unit Abutments, 3.4-5.7 mm, 0°
- · 3i OSSEOTITE®
- · Astra Tech OsseoSpeed™
- · Neodent Grand Morse
- NobelReplace® Trilobe
- · NobelReplace® Conical
- · Nobel Brånemark System®
- · Straumann BLX Implants
· DESS Dental Multi Unit Abutments. Angled. 3.4-6.5 mm, max 30°
- · NobelActive® NobelParallel Conical
- Straumann® Bone Level
- · Zimmer Screw Vent® and Tapered Screw-Vent®
· Dentium SuperLine® Abutments, 4.5-5.5 mm, max30°
· Genesis ACTIVE™ Multi-Unit Abutments, 4.8mm, max 30°
· Implant Direct GPS® Angled Abutment, 5.0mm, max 30°
KDG Abutments, 4.8mm, max 30°
· Keystone Multi Unit Abutment, 4.8mm, 0°
· Medentika Multi Unit Abutments, 4.8mm, max 30°
- · EV Series Dentsply® Implants Astratech Osseospeed®
- · F Series Nobel Biocare NobelActive® NobelReplace® Conical
- · H Series Biomet 3i Certain®
- L Series Straumann Bone Level
- · N Series Straumann Soft tissue Level
- · R Series Zimmer Dental Tapered Screwvent®
Medentika Multi Unit Abutments, 4.8mm, 0°
- E Series Nobel Biocare Replace™ Select
- · I Series Biomet 3i Osseotite®
- K Series Nobel Biocare™ Branemark
- · S Series Astra Tech OsseoSpeedTM
- · T Series Dentsply Friadent® Frialit/Xive®
· MegaGen Multi Unit Abutments, 4.8mm, max 30°
· Xpeed® AnyRidge® Internal Implant System
AnyOne® Internal Implant System
AnyRidge® Octa 1 Implant System
AnyOne® External Implant System
AnyRidge® Octa 1 Implant System
AnyOne® Internal Implant System
Rescue Internal Implant System
MIS Multi-unit Abutments, 4.8mm
- · C1 Conical Connection Implant System, max 30°
- · V3 Conical Connection Implant System, max 30°
- · Internal Hex Implant System, max 30°
- · Conical Connection, max 30°
· Neodent GM Mini Conical Abutment, 4.8 mm, max 30°
· Nobel Biocare™ Brånemark Multi Unit Abutment, 4.8 mm, max 17°
· Nobel Biocare™ Multi Unit Abutment Plus, 4.8 mm, max 30°
· Nobel Biocare™ Multi Unit Abutment, 4.8 mm, max 30°
Nobel Biocare™ Multi Unit Abutments for Straumann and Astra Tech System, 4.8 mm, max 30°
Nobel Biocare™ Multi Unit Abutments for Astra Tech, Camlog and Ankylos Implant Systems, 4.8 mm, max 30°
· Nobel Biocare Xeal Abutments, 4.8 mm, max 30°
· OSSTEM Multi Unit Abutment, 4.8mm, max 30°
- SS SA Fixture Implants
- SA Implant System
- · ET US SSS Prosthetic System
· Paltop Multi Unit Abutment, 5.0 mm, max 17°
· Southern Compact Conical Abutments, 4.8 mm
- MAX Implant System, 0°
- · Provata Implant System, max 30°
- · Deep Conical (DC) Implants, 0°
- · Piccolo Implants, 0°
- · External Hex Implants, max 30°
Straumann® BLX Screw Retained Abutment, 4.6 mm, max 30°
· Straumann® Screw Retained Abutment, 4.6 mm, max 30°
· Zimmer Angled Tapered Abutments, 4.5 mm, max 30°

Device Description

The Osteon Precision Milled Suprastructures (also referred to as superstructures) are metallic dental restorative devices that are intended to be attached by screw retention to dental implant abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring chewing function. These suprastructures attach to dental implant abutments using the prosthetic screws from the original equipment manufacturers (OEM) and are used to support the final multi-unit restoration.

The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's dental impression. The suprastructure is manufactured with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical.

Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence are categorized as Type A and Type B.

Type A: Intended to act as a supporting structure to facilitate the attachment of a removable dental prosthesis and include Primary Bar and Nexus Removable Bar.
. Type B: Intended to act as a supporting structure to facilitate the attachment of a fixed dental prosthesis and include Melbourne Bar and Nexus Fixed Bar (including Nexus Hybrid, Nexus Bridge, Micro Nexus, and Nexus Wraparound).

AI/ML Overview

The provided FDA 510(k) summary (K233083) describes the acceptance criteria and study for the Osteon Precision Milled Suprastructure.

1. Table of Acceptance Criteria and Reported Device Performance

This submission is a 510(k) for an expansion of an existing device (K221019) to add compatibility with new OEM abutment systems and introduce three new Type B Nexus Fixed Bars. The acceptance criteria are primarily based on demonstrating substantial equivalence to the predicate devices in terms of intended use, technological characteristics, and material composition.

The tables below synthesize the design specifications (acceptance criteria) and the device's performance (reported as meeting these specifications) by demonstrating substantial equivalence to predicate devices.

Table 1: Comparison of General Characteristics and Materials (summarized for clarity)

Characteristic	Acceptance Criteria (Predicate)	Reported Device Performance (Subject Device)
Intended Use	Dental implant abutment for restoring chewing function in partially or fully edentulous jaws, attached to a minimum of two abutments. Specific compatible OEM abutment systems listed.	Substantially Equivalent. The subject device shares the same intended use. The primary difference is an expanded list of compatible OEM abutment systems.
Device Material	Titanium alloy Ti-6Al-4V (ASTM F136)	Meets/Substantially Equivalent. Manufactured from titanium alloy conforming to ASTM F136.
Design/Technology	CAD/CAM milling from single milling blanks	Meets/Substantially Equivalent. CAD/CAM milling from single milling blanks.
Design/Construction	Patient specific/machined	Meets/Substantially Equivalent. Patient specific/machined.
Sterility	Supplied Nonsterile	Meets/Substantially Equivalent. Supplied Nonsterile (to be sterilized by end-user).
Prescription/OTC	Prescription only	Meets/Substantially Equivalent. Prescription only.
Recommended Cleaning & Maintenance	Proper oral hygiene	Meets/Substantially Equivalent. Proper oral hygiene.

Table 2: Design Specifications (Acceptance Criteria vs. Reported Performance)

Design Parameters	Type A (Removable Prosthesis) Acceptance Criteria (Predicate)	Type B (Fixed Prosthesis) Acceptance Criteria (Predicate)	Type A (Removable Prosthesis) Reported Performance (Subject Device)	Type B (Fixed Prosthesis) Reported Performance (Subject Device)
Total Cylinders	2-10	2-10	2-10	2-10
Suprastructure Span Between Cylinders (mm)	1-30 mm	1-30 mm	1-30 mm	1-30 mm
Suprastructure Height (mm)	3-12 mm	3*-22 mm	3-12 mm	3*-22 mm
Suprastructure Width (mm)	3.4-12 mm	3.4**-12 mm	3.4-12 mm	3.4**-12 mm
Distal Cantilever Section (mm)	0-15 mm	0-15 mm	0-15 mm	0-15 mm
Cylinder Height (mm)	0-4.6 mm	0-4.6 mm	0-4.6 mm	0-4.6 mm
Cylinder Diameter (mm)	4.5-8 mm	4.5-8 mm	4.5-8 mm	4.5-8 mm

*Note for Suprastructure Height: The Minimum Suprastructure Height for the Micro Nexus Bar (a new Type B bar in the subject device) is 2.5 mm, which is within the stated range of 3*-22 mm, where * indicates variability for this new bar.
**Note for Suprastructure Width: The Minimum Suprastructure Width for the Micro Nexus Bar (a new Type B bar in the subject device) is 2.5 mm, which is within the stated range of 3.4**-12 mm, where ** indicates variability for this new bar.

2. Sample size used for the test set and the data provenance

The submission is a 510(k) for an expansion of an existing device (K221019). The "study" proving the device meets acceptance criteria primarily relies on non-clinical data and demonstration of substantial equivalence to predicate devices.

Test set/Sample size: The document does not describe a "test set" in the traditional sense of a clinical or imaging study with a defined sample size for statistical analysis. Instead, it relies on:
- Reverse engineering analysis of OEM abutments and OEM abutment screws: This was done to confirm compatibility. The sample size for this analysis is not explicitly stated but would involve the specific OEM abutments listed for compatibility with the subject device.
- Fatigue testing: The document states, "Fatigue testing was not performed since the Subject devices are abutment-borne and are not intended to compensate for angulation in excess of the maximum angulation of OEM angled abutments..." This indicates that engineering analysis and design specifications, rather than physical fatigue testing, were used to demonstrate performance in this regard.
Data provenance: Not directly applicable as there isn't a "test set" from patients. The data relies on engineering analysis, existing predicate device data, and compliance with standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study requiring expert readers to establish ground truth. Substantial equivalence claims are based on engineering, material, and design comparisons to legally marketed devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no "test set" or diagnostic performance study that would require an adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical dental suprastructure, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical dental suprastructure, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" equivalent for this submission is the established safety and effectiveness of the primary predicate device (K221019) and various reference devices, supported by:

Compliance with recognized standards: Biocompatibility (ISO 10993-5, ISO 10993-12), sterilization validation (ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2, ANSI/AAMI/ISO 14937).
Material specifications: Conformance to ASTM F136 for titanium alloy.
Engineering analysis and design specifications: Comparison of design features to predicate devices and confirmation of compatibility through reverse engineering.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 9, 2024

Implant Solutions PTY LTD (aka Osteon Medical) % Farah Rahman QA/RA Manager 759-767 Springvale Road Mulgrave. Victoria 3170 AUSTRALIA

Re: K233083

Trade/Device Name: Osteon Precision Milled Suprastructure Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: January 30, 2024 Received: February 5, 2024

Dear Farah Rahman:

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.

{1}------------------------------------------------

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 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-reportingcombination-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.

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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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

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Indications for Use

510(k) Number (if known) K233083

Device Name Osteon Precision Milled Suprastructure

Indications for Use (Describe)

The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems:

· Astra Tech Implant System® Multi Base Abutment EV, 4.8mm, max 30°
· BioHorizons Multi Unit Abutment, 4.8mm, max 30°
- · CONELOG® Implant System
· Biomet 3 i Multi Unit Abutments, 4.8mm, max 30°
- · TSXTM Implants
- · Tapered Screw-Vent Implant
· DESS Dental Multi Unit Abutments, 3.4-5.7 mm, 0°
- · 3i OSSEOTITE®
- · Astra Tech OsseoSpeed™
- · Neodent Grand Morse
- NobelReplace® Trilobe
- · NobelReplace® Conical
- · Nobel Brånemark System®
- · Straumann BLX Implants
· DESS Dental Multi Unit Abutments. Angled. 3.4-6.5 mm, max 30°
- · NobelActive® NobelParallel Conical
- Straumann® Bone Level
- · Zimmer Screw Vent® and Tapered Screw-Vent®
· Dentium SuperLine® Abutments, 4.5-5.5 mm, max30°
· Genesis ACTIVE™ Multi-Unit Abutments, 4.8mm, max 30°
· Implant Direct GPS® Angled Abutment, 5.0mm, max 30°
KDG Abutments, 4.8mm, max 30°
· Keystone Multi Unit Abutment, 4.8mm, 0°
· Medentika Multi Unit Abutments, 4.8mm, max 30°
- · EV Series Dentsply® Implants Astratech Osseospeed®
- · F Series Nobel Biocare NobelActive® NobelReplace® Conical
- · H Series Biomet 3i Certain®
- L Series Straumann Bone Level
- · N Series Straumann Soft tissue Level
- · R Series Zimmer Dental Tapered Screwvent®
Medentika Multi Unit Abutments, 4.8mm, 0°
- E Series Nobel Biocare Replace™ Select
- · I Series Biomet 3i Osseotite®
- K Series Nobel Biocare™ Branemark
- · S Series Astra Tech OsseoSpeedTM
- · T Series Dentsply Friadent® Frialit/Xive®
· MegaGen Multi Unit Abutments, 4.8mm, max 30°

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· Xpeed® AnyRidge® Internal Implant System
AnyOne® Internal Implant System
AnyRidge® Octa 1 Implant System
AnyOne® External Implant System
AnyRidge® Octa 1 Implant System
AnyOne® Internal Implant System
Rescue Internal Implant System
MIS Multi-unit Abutments, 4.8mm
- · C1 Conical Connection Implant System, max 30°
- · V3 Conical Connection Implant System, max 30°
- · Internal Hex Implant System, max 30°
- · Conical Connection, max 30°
· Neodent GM Mini Conical Abutment, 4.8 mm, max 30°
· Nobel Biocare™ Brånemark Multi Unit Abutment, 4.8 mm, max 17°
· Nobel Biocare™ Multi Unit Abutment Plus, 4.8 mm, max 30°
· Nobel Biocare™ Multi Unit Abutment, 4.8 mm, max 30°
Nobel Biocare™ Multi Unit Abutments for Straumann and Astra Tech System, 4.8 mm, max 30°
Nobel Biocare™ Multi Unit Abutments for Astra Tech, Camlog and Ankylos Implant Systems, 4.8 mm, max 30°
· Nobel Biocare Xeal Abutments, 4.8 mm, max 30°
· OSSTEM Multi Unit Abutment, 4.8mm, max 30°
- SS SA Fixture Implants
- SA Implant System
- · ET US SSS Prosthetic System
· Paltop Multi Unit Abutment, 5.0 mm, max 17°
· Southern Compact Conical Abutments, 4.8 mm
- MAX Implant System, 0°
- · Provata Implant System, max 30°
- · Deep Conical (DC) Implants, 0°
- · Piccolo Implants, 0°
- · External Hex Implants, max 30°
Straumann® BLX Screw Retained Abutment, 4.6 mm, max 30°
· Straumann® Screw Retained Abutment, 4.6 mm, max 30°
· Zimmer Angled Tapered Abutments, 4.5 mm, max 30°

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

] Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K233083

Implant Solutions PTY LTD (aka Osteon Medical)

Osteon Precision Milled Suprastructure

March 08, 2024

ADMINISTRATIVE INFORMATION
Manufacturer	Implant Solutions PTY LTD (aka Osteon Medical)759-767 Springvale Road Mulgrave, Victoria 3170, AustraliaTelephone:+61 392-640-111
Official Contact	Farah Rahman, QARA Manager
DEVICE NAME AND CLASSIFICATION
Trade/Device Name	Osteon Precision Milled Suprastructure
Common Name	Dental implant abutment
Regulation Number	21 CFR 872.3630
Regulation Name	Endosseous dental implant abutment
Regulatory Class	Class II
Product Code	NHA
Classification Panel	Dental Products Panel
Reviewing Office	Office of Health Technology 1 (OHT 1: Ophthalmic, Anesthesia,Respiratory, ENT and Dental Devices)
Reviewing Division	Division of Health Technology 1 B (Dental and ENT Devices)

PREDICATE DEVICE INFORMATION

Primary Predicate Device:

. K221019, Osteon Precision Milled Suprastructure, Implant Solutions PTY LTD (aka Osteon Medical)

Reference Devices for OEM Compatibilities:

K212676, Osteon Precision Milled Suprastructure, Implant Solutions Pty Ltd (aka Osteon Medical) ●
K221381, KDG Abutments, Keystone Dental Inc.
K223814, Genesis ACTIVE Implant System, Keystone Dental Inc.
K203252, Multi-unit Abutments for CONELOG®, BioHorizons Implant Systems, Inc.
K092341, Low Profile Abutments – Internal and External Connection, Biomet 31, Inc.
K203808, Multi-unit Abutment, Multi-unit Angled Abutment, MegaGen Implant Co., Ltd.
K203554, AnyOne® External Implant System, MegaGen Implant Co., Ltd.

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510(k) Summary Page 2 of 11

K063216, Rescue Internal Dental Implant System, MegaGen Implant Co., Ltd.
K221684, OSSTEM Abutment System, Osstem Implant Co., Ltd.
K163557, SS SA Fixture, Osstem Implant Co., Ltd.
K161689, OSSTEM Implant System - Abutment, Osstem Implant Co., Ltd
K161103, US SA Implant System, Osstem Implant Co., Ltd. ●
K160670, ET US SS Prosthetic system, Osstem Implant Co., Ltd.
K123755, Multi Angled Abutment, Osstem Implant Co., Ltd.
K191123, Multi-unit Abutments, Medentika GmbH
K142167, Medentika Abutment System, Medentika GmbH

INDICATIONS FOR USE STATEMENT

The Osteon Precision Milled Suprastructure is indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.

The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems:

. Astra Tech Implant System® Multi Base Abutment EV, 4.8mm, max 30°
. BioHorizons Multi Unit Abutment, 4.8mm, max 30°
- CONELOG® Implant System ●
. Biomet 3i Multi Unit Abutments, 4.8mm, max 30°
- TSX™ Implants
- Tapered Screw-Vent Implant
DESS Dental Multi Unit Abutments, 3.4-5.7 mm, 0°
- 3i OSSEOTITE®
- Astra Tech OsseoSpeed™ ●
- Neodent Grand Morse
- NobelReplace® Trilobe
- NobelReplace® Conical
- Nobel Brånemark System®
- Straumann BLX Implants
DESS Dental Multi Unit Abutments, Angled, 3.4-6.5 mm, max 30°
- NobelActive® NobelParallel Conical
- Straumann® Bone Level ●
- Zimmer Screw Vent® and Tapered Screw-Vent®
Dentium SuperLine® Abutments, 4.5-5.5 mm, max30°
GENESIS ACTIVE™ Multi-Unit Abutments, 4.8mm, max 30°
Implant Direct GPS® Angled Abutment, 5.0mm, max 30°
KDG Abutments, 4.8mm, max 30°
. Keystone Multi Unit Abutment, 4.8mm, 0°
Medentika Multi Unit Abutments, 4.8mm, max 30°
- EV Series Dentsply® Implants Astratech Osseospeed® ●
- F Series – Nobel Biocare NobelActive® – NobelReplace® Conical
- H Series - Biomet 3i Certain®
- L Series Straumann Bone Level ●

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●

N Series – Straumann Soft tissue Level
R Series - Zimmer Dental Tapered Screwvent®
Medentika Multi Unit Abutments, 4.8mm, 0°
- E Series – Nobel Biocare Replace™ Select
- I Series Biomet 3i Osseotite® ●
- K Series – Nobel Biocare™ Branemark
- S Series Astra Tech OsseoSpeed™ ●
- T Series Dentsply Friadent® Frialit/Xive® ●
MegaGen Multi Unit Abutments, 4.8mm, max 30°
- Xpeed® AnyRidge® Internal Implant System ●
- AnyOne® Internal Implant System ●
- . AnyRidge® Octa 1 Implant System
- AnyOne® External Implant System
- AnyRidge® Octa 1 Implant System ●
- AnyOne® Internal Implant System
- Rescue Internal Implant System
MIS Multi-unit Abutments, 4.8mm
- C1 Conical Connection Implant System, max 30° ●
- V3 Conical Connection Implant System, max 30°
- Internal Hex Implant System, max 30°
- Conical Connection, max 30°
Neodent GM Mini Conical Abutment, 4.8 mm, max 30°
Nobel Biocare™ Brånemark Multi Unit Abutment, 4.8 mm, max 17°
Nobel Biocare™ Multi Unit Abutment Plus, 4.8 mm, max 30°
. Nobel Biocare™ Multi Unit Abutment, 4.8 mm, max 30°
. Nobel Biocare™ Multi Unit Abutments for Straumann and Astra Tech System, 4.8 mm, max 30°
. Nobel Biocare™ Multi Unit Abutments for Astra Tech, Camlog and Ankylos Implant Systems, 4.8 mm, max 30°
. Nobel Biocare Xeal Abutments, 4.8 mm, max 30°
OSSTEM Multi Unit Abutment, 4.8mm, max 30°
- SS SA Fixture Implants ●
- . SA Implant System
- ET US SSS Prosthetic System ●
Paltop Multi Unit Abutment, 5.0 mm, max 17°
. Southern Compact Conical Abutments, 4.8 mm
- MAX Implant System, 0°
- Provata Implant System, max 30°
- Deep Conical (DC) Implants, 0° ●
- Piccolo Implants, 0° ●
- External Hex Implants, max 30°
Straumann® BLX Screw Retained Abutment, 4.6 mm, max 30° ●
Straumann® Screw Retained Abutment, 4.6 mm, max 30°
. Zimmer Angled Tapered Abutments, 4.5 mm, max 30°

{8}------------------------------------------------

SUBJECT DEVICE DESCRIPTION

The purpose of this submission is to expand the Osteon Precision Milled Suprastructure cleared under K221019, K2121019, K221381 and K223814 to add additional OEM compatibility to BioHorizons Abutments, Biomet 3i Abutments, MegaGen Abutments, OSSTEM Abutments, and Medentika Abutments. Three (3) additional Type B Nexus Fixed Bars have been designed to accommodate additional fixed dental prosthesis types (Nexus Bridge, Micro Nexus Wraparound). The Micro Nexus Bar can be utilized when up to half of the arch is considered for a restoration, while the Nexus Hybrid, Nexus Bridge, and Nexus Wraparound are utilized for full arched fixed restorations and selection of the bar type is made based on aesthetic requirements of the patient.

Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence are categorized as Type A and Type B.

Type A: Intended to act as a supporting structure to facilitate the attachment of a removable dental prosthesis and include Primary Bar and Nexus Removable Bar.
. Type B: Intended to act as a supporting structure to facilitate the attachment of a fixed dental prosthesis and include Melbourne Bar and Nexus Fixed Bar (including Nexus Hybrid, Nexus Bridge, Micro Nexus, and Nexus Wraparound).

Description	Type A (For RemovableProsthesis)		Type B(For Fixed Prosthesis)
	Minimum	Maximum	Minimum	Maximum
Total Cylinders	2	10	2	10
Suprastructure Span Between Cylinders (mm)	1	30	1	30
Suprastructure Height (mm)	3	12	3*	22
Suprastructure Width (mm)	3.4	12	3.4**	12
Distal Cantilever Section (mm)***	0	15	0	15
Cylinder Height (mm)	0	4.6	0	4.6
Cylinder Diameter (mm)	4.5	8	4.5	8

The table below presents the design specifications for two categories of suprastructures:

*The Minimum Suprastructure Height for the Micro Nexus Bar is 2.5 mm. This is where the cut outs are optional.

**The Minimum Suprastructure Width for the Micro Nexus Bar is 2.5 mm. This is where the cut outs are optional.

***Distal Cantilever Section is not applicable for Micro Nexus Bar as this bar could be designed to fit anywhere within the arch.

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MATERIAL COMPOSITION

The Osteon Precision Milled Suprastructure is manufactured from titanium alloy conforming to the requirements of ASTM F136 Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). This material to that of the primary predicate device K221019.

PERFORMANCE DATA

Non-clinical data submitted to demonstrate substantial equivalence included: biocompatibility according to ISO 10993-5 and ISO 10993-12 leveraged from K212676; sterilization validation according to ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2 and ANSI/AAMI/ISO 14937 and reverse engineering analysis of OEM abutments and OEM abutment screws to confirm compatibility. No clinical data were included in this submission.

EQUIVALENCE TO MARKETED DEVICE

The Subject device is substantially equivalent in indications and design principles to the primary predicate device listed above. Provided at the end of this summary is a table comparing the Indications for Use Statements and the technological characteristics of the Subject device and the Primary Predicate device K221019 and Reference devices K212676, K221381 and K223814.

The Subject device is substantially equivalent in intended use to the Primary Predicate device cleared in K221019 and Reference Devices K212676, K221381 and K223814. The Indications for Use Statement (IFUS) for the Subject device is substantially equivalent to that of the Primary Predicate K221019, except for the list of compatible OEM implants.

The Subject device is identical in design, materials, and technological characteristics to the corresponding Primary Predicate device K221019 and Reference devices K212676, K221381 and K223814. There have been no changes to the previously cleared bars, and they remain the same as the Primary Predicate K221019. New bar cylinders (mating components) have been designed to accommodate the new compatible abutments that, other than the compatibilities, are identical to the bar cylinders that were cleared in the Primary Predicate K221019. Three additional Type B Fixed Prosthesis Bars are within this submission, including the Nexus Bridge, Micro Nexus, and Nexus Wraparound. These bars are similar in design to the Primary Predicate K221019, with the use of the bar cylinders to create the custom bar design for a specific patient. Fatigue testing was not performed since the Subject devices are abutment-borne and are not intended to compensate for angulation in excess of the maximum angulation of OEM angled abutments in each Reference device clearance, as outlined in the Indications for Use Statement.

The Subject device is to be sterilized by the end-user, highly similar to primary predicate device K221019 and Reference devices K212676, K221381 and K223814.

The Subject device is to be manufactured from the same materials and in the same facilities using the same manufacturing processes as used for the Osteon Precision Milled Suprastructure previously cleared in K221019. Therefore, no new biocompatibility testing has been performed, as the Subject device is substantially equivalent to the predicate devices in K221019 and the Reference devices in K212676, K221381 and K223814 with regard to materials and processing.

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CONCLUSION

The Subject device and the primary predicate device have the same intended use, have similar technological characteristics, and are made of the same materials. The Subject device and the primary predicate encompass the same range of physical dimensions, are packaged in same materials, and are to be sterilized using highly similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

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Osteon Precision Milled Suprastructure

Table of Substantial Equivalence - Technological Characteristics
------------------------------------------------------------------	--	--	--	--

Characteristic	Subject Device:Osteon Precision MilledSuprastructureImplant Solutions PTY LTD(aka Osteon Medical)	Primary Predicate Device:Osteon Precision MilledSuprastructureImplant Solutions PTY LTD(aka Osteon Medical)	Reference Device:Osteon Precision MilledSuprastructure, K212676Implant Solutions PTY LTD(akaOsteon Medical)	Reference Device:KDG Abutments, K221381,Keystone Dental Inc.	Reference Device:Genesis ACTIVE ImplantSystem, K223814, KeystoneDental Inc.
Indications	The Osteon Precision MilledSuprastructure is indicated forattachment to dental abutmentsin the treatment of partially orfully edentulous jaws for thepurpose of restoring chewingfunction. The Osteon PrecisionMilled Suprastructures areintended for attachment to aminimum of two (2) abutments.The Osteon Milled Suprastructureis indicated for compatibility withthe following abutment systems:• Astra Tech Implant System®Multi Base Abutment EV,4.8mm, max 30°• BioHorizons Multi UnitAbutment, 4.8mm, max 30°• CONELOG® Implant System• Biomet 3i Multi UnitAbutments, 4.8mm, max 30°• TSX™ Implants• Tapered Screw-VentImplant• DESS Dental Multi UnitAbutments, 3.4-5.7 mm, 0°• 3i OSSEOTITE®• Astra Tech OsseoSpeed™• Neodent Grand Morse• NobelReplace® Trilobe• NobelReplace® Conical• Nobel Brånemark System®• Straumann BLX Implants• DESS Dental Multi UnitAbutments, Angled, 3.4-6.5mm, max 30°• NobelActive® NobelParallelConical• Straumann® Bone Level	The Osteon Precision MilledSuprastructure is indicated forattachment to dentalabutments in the treatment ofpartially or fully edentulousjaws for the purpose ofrestoring chewing function.The Osteon Precision MilledSuprastructures are intendedfor attachment to a minimumof two (2) abutments.The Osteon MilledSuprastructure is indicated forcompatibility with thefollowing abutment systems:• Astra Tech Implant System®Multi Base Abutment EV, 4.8mm, max 30°• DESS Dental Multi UnitAbutments, 3.4-5.7 mm, 0°• 3i OSSEOTITE®• Astra Tech OsseoSpeed™• Neodent Grand Morse• NobelReplace Conical• NobelReplace Trilobe• Nobel Brånemark System®• Straumann BLX Implants• DESS Dental Multi UnitAbutments, Angled, 3.4-6.5mm, max 30°• NobelActive® NobelParallelConical• Straumann® Bone Level• Zimmer Screw Vent andTapered Screw-Vent• Dentium SuperLine®Abutments, 4.5-5.5 mm, max30°	The Osteon Precision MilledSuprastructure is indicated forattachment to dentalabutments in the treatment ofpartially or fully edentulousjaws for the purpose ofrestoring chewing function.The Osteon Precision MilledSuprastructures are intendedfor attachment to a minimumof two (2) abutments.The Osteon Milled Suprastructureis indicated for compatibility withthe following abutment systems:• Astra Tech Implant System®Multi Base Abutment EV, 4.8mm, max 30°• Dentium SuperLine®Abutments, 4.5-5.5 mm, max30°• Keystone Multi Unit Abutment,4.8 mm, 0°• Implant Direct GPS® AngledAbutment, 5.0 mm, max 30°• MIS Multi-unit Abutments, 4.8mm• C1 Conical ConnectionImplant System, max 30°• V3 Conical ConnectionImplant System, max 30°• Internal Hex ImplantSystem, max 30°• Conical Connection, max30°• Neodent GM Mini ConicalAbutment, 4.8 mm, max 30°• Nobel Biocare Multi Unit	KDG Abutments are pre-manufactured prostheticcomponents for directconnection to endosseousdental implants and areintended for use as an aid inprosthetic rehabilitation.The KDG-Osteon PrecisionMilled Suprastructure isindicated for attachment toKDG Abutments in thetreatment of partially or fullyedentulous jaws for thepurpose of restoring chewingfunction. The KDG-OsteonPrecision MilledSuprastructure is intended forattachment to a minimum oftwo (2) abutments.	The Genesis ACTIVE ImplantSystem is intended for use insingle-stage or two-stagesurgical procedures forreplacing single or multiplemissing teeth in partially orfully edentulous mandiblesand maxillae. The GenesisACTIVE Implant Systemsupports single or multiple-unit restorations to re-establish patient chewingfunction and esthetics. GenesisACTIVE implants are intendedfor placement followingnatural tooth loss or forimmediate placement into anextraction socket. Immediatefunction may be achievedwhen good primary stability isestablished, and appropriateocclusal loading is applied.All digitally designed customabutments for use withGenesis ACTIVE ImplantSystem implants are to be sentto aKeystone Dental validatedmilling center formanufacture.The KDG-Osteon PrecisionMilled Suprastructure isindicated for attachment tothe Genesis ACTIVE Multi-Unitabutments in the treatment of
Characteristic	Subject Device:Osteon Precision MilledSuprastructureImplant Solutions PTY LTD(aka Osteon Medical)	Primary Predicate Device:Osteon Precision MilledSuprastructureImplant Solutions PTY LTD(aka Osteon Medical)	Reference Device:Osteon Precision MilledSuprastructure, K212676Implant Solutions PTY LTD(akaOsteon Medical)	Reference Device:KDG Abutments, K221381,Keystone Dental Inc.	Reference Device:Genesis ACTIVE ImplantSystem, K223814, KeystoneDental Inc.
	• Zimmer Screw Vent® andTapered Screw-Vent®• Dentium SuperLine®Abutments, 4.5-5.5 mm,max30°• GENESIS ACTIVE™ Multi-UnitAbutments, 4.8mm, max 30°• Implant Direct GPS® AngledAbutment, 5.0mm, max 30°• KDG Abutments, 4.8mm, max30°• Keystone Multi Unit Abutment,4.8mm, 0°• Medentika Multi UnitAbutments, 4.8mm, max 30°• EV Series - Dentsply®Implants AstratechOsseospeed®• F Series – Nobel BiocareNobelActive® -NobelReplace® Conical• H Series - Biomet 3iCertain®• L Series - Straumann BoneLevel• N Series - Straumann Softtissue Level• R Series – Zimmer DentalTapered Screwvent®• Medentika Multi UnitAbutments, 4.8mm, 0°• E Series - Nobel BiocareReplace™ Select• I Series – Biomet 3iOsseotite®• K Series - Nobel Biocare™Branemark• S Series – Astra TechOsseoSpeed™• T Series - DentsplyFriadent® Frialit/Xive®	• Keystone Multi Unit Abutment,4.8 mm, 0°• Implant Direct GPS® AngledAbutment, 5.0 mm, max 30°• MIS Multi-unit Abutments, 4.8mm• C1 Conical ConnectionImplant System, max 30°• V3 Conical ConnectionImplant System, max 30°• Internal Hex ImplantSystem, max 30°• Conical Connection, max30°• Neodent GM Mini ConicalAbutment, 4.8 mm, max 30°• Nobel Biocare Brånemark MultiUnit Abutment, 4.8 mm, max30°• Nobel Biocare Multi UnitAbutment Plus, 4.8 mm, max30°• Nobel Biocare Multi UnitAbutment, 4.8 mm, max 30°• Nobel Biocare Multi UnitAbutments for Straumann andAstra Tech System, 4.8mm, max30°• Nobel Biocare Multi UnitAbutments for Astra Tech,Camlog and Ankylos ImplantSystems, 4.8 mm, max 30°• Nobel Biocare Xeal Abutments,4.8 mm, max 30°• Paltop Multi Unit Abutment,5.0 mm, max 17°• Southern Compact ConicalAbutments, 4.8 mm• MAX Implant System, 0°• Provata Implant System,max 30°• Deep Conical (DC) Implants,	• Nobel Biocare Multi UnitAbutment, 4.8 mm, max 30°• Nobel Biocare Xeal Abutments,4.8 mm, max 30°• Paltop Multi Unit Abutment,5.0 mm, max 17°• Southern Compact ConicalAbutments, 4.8 mm• MAX Implant System, 0°• Provata Implant System,max 30°• Deep Conical (DC) Implants,0°• Piccolo Implants, 0°• External Hex Implants, max30°Zimmer Angled TaperedAbutments, 4.5 mm, max 30°		partially or fully edentulousjaws for the purpose ofrestoring chewing function.The KDGOsteon PrecisionMilled Suprastructure isintended for attachment to aminimum of two (2)abutments.
Characteristic	Subject Device:Osteon Precision MilledSuprastructureImplant Solutions PTY LTD(aka Osteon Medical)	Primary Predicate Device:Osteon Precision MilledSuprastructureImplant Solutions PTY LTD(aka Osteon Medical)	Reference Device:Osteon Precision MilledSuprastructure, K212676Implant Solutions PTY LTD(akaOsteon Medical)	Reference Device:KDG Abutments, K221381,Keystone Dental Inc.	Reference Device:Genesis ACTIVE ImplantSystem, K223814, KeystoneDental Inc.
	• MegaGen Multi UnitAbutments, 4.8mm, max 30°• Xpeed® AnyRidge® InternalImplant System• AnyOne® Internal ImplantSystem• AnyRidge® Octa 1 ImplantSystem• AnyOne® External ImplantSystem• AnyRidge® Octa 1 ImplantSystem• AnyOne® Internal ImplantSystem• Rescue Internal ImplantSystem• MIS Multi-unit Abutments,4.8mm• C1 Conical ConnectionImplant System, max 30°• V3 Conical ConnectionImplant System, max 30°• Internal Hex ImplantSystem, max 30°• Conical Connection, max30°• Neodent GM Mini ConicalAbutment, 4.8 mm, max 30°• Nobel Biocare™ BrånemarkMulti Unit Abutment, 4.8 mm,max 17°• Nobel Biocare™ Multi UnitAbutment Plus, 4.8 mm, max30°• Nobel Biocare™ Multi UnitAbutment, 4.8 mm, max 30°• Nobel Biocare™ Multi UnitAbutments for Straumann andAstra Tech System, 4.8 mm,max 30°• Nobel Biocare™ Multi UnitAbutments for Astra Tech,	0°• Piccolo Implants, 0°• External Hex Implants, max30°• Straumann® BLX ScrewRetained Abutment, 4.6 mm,max30°• Straumann® Screw RetainedAbutment, 4.6 mm, max 30°• Zimmer Angled TaperedAbutments, 4.5 mm, max 30°
Characteristic	Subject Device:Osteon Precision MilledSuprastructureImplant Solutions PTY LTD(aka Osteon Medical)	Primary Predicate Device:Osteon Precision MilledSuprastructureImplant Solutions PTY LTD(aka Osteon Medical)	Reference Device:Osteon Precision MilledSuprastructure, K212676Implant Solutions PTY LTD(akaOsteon Medical)	Reference Device:KDG Abutments, K221381,Keystone Dental Inc.	Reference Device:Genesis ACTIVE ImplantSystem, K223814, KeystoneDental Inc.
	Camlog and Ankylos ImplantSystems, 4.8 mm, max 30°• Nobel Biocare Xeal Abutments,4.8 mm, max 30°• OSSTEM Multi Unit Abutment,4.8mm, max 30°• SS SA Fixture Implants• SA Implant System• ET US SSS ProstheticSystem• Paltop Multi Unit Abutment,5.0 mm, max 17°• Southern Compact ConicalAbutments, 4.8 mm• MAX Implant System, 0°• Provata Implant System,max 30°• Deep Conical (DC) Implants,0°• Piccolo Implants, 0°• External Hex Implants, max30°• Straumann® BLX ScrewRetained Abutment, 4.6 mm,max 30°• Straumann® Screw RetainedAbutment, 4.6 mm, max 30°• Zimmer Angled TaperedAbutments, 4.5 mm, max 30°
Device Material	Titanium alloy Ti-6Al- 4V	Titanium alloy Ti-6Al- 4V	Titanium alloy Ti-6Al- 4V	Grade 23 Titanium Alloy, Nomodified surface	Titanium alloy Ti-6Al- 4V
Design/Technology	CAD/CAM milling from singlemilling blanks.	CAD/CAM milling from singlemilling blanks.	CAD/CAM milling from singlemilling blanks.	CAD/CAM milling	CAD/CAM milling
Design/Construction	Patient specific/ machined	Patient specific/ machined	Patient specific/ machined	Patient specific/ machined	Patient specific/ machined
Sterility	Supplied Nonsterile	Supplied Nonsterile	Supplied Nonsterile	Supplied Nonsterile	Supplied Nonsterile
Prescription/OTC	Prescription only	Prescription only	Prescription only	Prescription only	Prescription only
RecommendedCleaning andMaintenance	Proper oral hygiene	Proper oral hygiene	Proper oral hygiene	Proper oral hygiene	Proper oral hygiene

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Table of Substantial Equivalence – Design Specifications

Characteristic	Subject Device:Osteon Precision MilledSuprastructureImplant Solutions PTY LTD (akaOsteon Medical)		Primary Predicate Device:Osteon Precision MilledSuprastructureImplant Solutions PTY LTD (akaOsteon Medical)		Reference Device:Osteon Precision MilledSuprastructure, K212676Implant Solutions PTY LTD(akaOsteon Medical)		Reference Device:KDG Abutments, K221381,Keystone Dental Inc.		Reference Device:Genesis ACTIVE ImplantSystem, K223814, KeystoneDental Inc.
DesignSpecifications	Type A	Type B	Type A	Type A	Type A	Type A	Type A	Type B	Type A	Type B
Total Cylinders	2-10	2-10	2-10	2-10	2-10	2-10	2-10	2-10	2-10	2-10
SuprastructureSpan BetweenCylinders (mm)	1-30 mm	1-30 mm	1-30 mm	1-30 mm	1-30 mm	1-30 mm	1-30 mm	1-30 mm	1-30 mm	1-30 mm
SuprastructureHeight (mm)	3-12 mm	3*-22 mm	3-12 mm	3-12 mm	3-12 mm	3-12 mm	3-12 mm	3-22 mm	3-12 mm	3-22 mm
SuprastructureWidth (mm)	3.4-12 mm	3.4**-12 mm	3.4-12 mm	3.4-12 mm	3.4-12 mm	3.4-12 mm	3.4-12 mm	3.4-12 mm	3.4-12 mm	3.4-12 mm
Distal CantileverSection(mm)***	0-15 mm	0-15 mm	0-15 mm	0-15 mm	0-15 mm	0-15 mm	0-15 mm	0-15 mm	0-15 mm	0-15 mm
Cylinder Height(mm)	0-4.6 mm	0-4.6 mm	0-4.6 mm	0-4.6 mm	0-4.6 mm	0-4.6 mm	0-4.6 mm	0-4.6 mm	0-4.6 mm	0-4.6 mm
CylinderDiameter (mm)	4.5-8 mm	4.5-8 mm	4.5-8 mm	4.5-8 mm	4.5-8 mm	4.5-8 mm	4.5-8 mm	4.5-8 mm	4.5-8 mm	4.5-8 mm

*The Minimum Suprastructure Height for the Micro Nexus Bar is 2.5 mm. This is where the cut outs are optional.

**The Minimum Suprastructure Width for the Micro Nexus Bar is 2.5 mm. This is where the cut outs are optional.

***Distal Cantilever Section is not applicable for Micro Nexus Bar as this bar could be designed to fit anywhere within the arch.

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
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.(b)
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.)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

8. The sample size for the training set

9. How the ground truth for the training set was established

Indications for Use

Indications for Use (Describe)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

510(k) Summary

K233083

Implant Solutions PTY LTD (aka Osteon Medical)

Osteon Precision Milled Suprastructure

March 08, 2024

PREDICATE DEVICE INFORMATION

Primary Predicate Device:

Reference Devices for OEM Compatibilities:

INDICATIONS FOR USE STATEMENT

SUBJECT DEVICE DESCRIPTION

MATERIAL COMPOSITION

PERFORMANCE DATA

EQUIVALENCE TO MARKETED DEVICE

CONCLUSION

Osteon Precision Milled Suprastructure

510(k) Summary Page 8 of 11

510(k) Summary Page 9 of 11

510(k) Summary Page 10 of 11

Table of Substantial Equivalence – Design Specifications

§ 872.3630 Endosseous dental implant abutment.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW