Who is the manufacturer of Osteon Precision Milled Suprastructure?

Implant Solutions Pty Ltd (Aka Osteon Medical) filed the 510(k) submission for Osteon Precision Milled Suprastructure (K233083).

What is the FDA product code for Osteon Precision Milled Suprastructure?

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

What is the regulatory pathway for Osteon Precision Milled Suprastructure?

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

What are the predicate devices for Osteon Precision Milled Suprastructure?

Osteon Precision Milled Suprastructure (K221019).

Who can help prepare an FDA 510(k) submission like Osteon Precision Milled Suprastructure?

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.

Osteon Precision Milled Suprastructure

K233083 · Implant Solutions Pty Ltd (Aka Osteon Medical) · NHA · Mar 9, 2024 · Dental

Device Facts

Record ID	K233083
Device Name	Osteon Precision Milled Suprastructure
Applicant	Implant Solutions Pty Ltd (Aka Osteon Medical)
Product Code	NHA · Dental
Decision Date	Mar 9, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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; 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°.

Device Story

Metallic dental restorative device (suprastructure) for partial/fully edentulous patients; attaches to dental implant abutments via OEM prosthetic screws. Input: patient dental impression scans. Transformation: CAD/CAM milling of titanium alloy (ASTM F136) to create patient-specific bars. Output: Type A (removable prosthesis support) or Type B (fixed prosthesis support, e.g., Nexus Bridge, Micro Nexus Wraparound). Used in dental clinics; operated by dental professionals. Output facilitates attachment of dental prostheses, restoring chewing function and aesthetics.

Clinical Evidence

Bench testing only. Biocompatibility leveraged from K212676 (ISO 10993-5, ISO 10993-12). Sterilization validation per ANSI/AAMI/ISO 17665-1, 17665-2, and 14937. Compatibility confirmed via reverse engineering of OEM abutments and screws. No clinical data included.

Technological Characteristics

Material: Titanium alloy (ASTM F136, UNS R56401). Principle: CAD/CAM milled patient-specific suprastructure. Form factor: Type A (removable) and Type B (fixed) bars. Connectivity: Mechanical screw-retention to OEM abutments. Sterilization: Supplied non-sterile, end-user sterilized.

Indications for Use

Indicated for attachment to dental abutments in treatment of partially or fully edentulous jaws to restore chewing function. Requires attachment to minimum of two abutments. Compatible with specified OEM abutment systems.

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

Osteon Precision Milled Suprastructure (K221019)

Reference Devices

Osteon Precision Milled Suprastructure (K212676)
KDG Abutments (K221381)
Genesis ACTIVE Implant System (K223814)
Multi-unit Abutments for CONELOG® (K203252)
Low Profile Abutments – Internal and External Connection (K092341)
Multi-unit Abutment, Multi-unit Angled Abutment (K203808)
AnyOne® External Implant System (K203554)
Rescue Internal Dental Implant System (K063216)
OSSTEM Abutment System (K221684)
SS SA Fixture (K163557)
OSSTEM Implant System - Abutment (K161689)
US SA Implant System (K161103)
ET US SS Prosthetic system (K160670)
Multi Angled Abutment (K123755)
Multi-unit Abutments (K191123)
Medentika Abutment System (K142167)

Related Devices

K173466 — Panthera Dental Milled Bars · Panthera Dental, Inc. · Jan 26, 2018
K122424 — ISUS IMPLANT SUPRASTRUCTURES · Dentsply International, Inc. · Jul 5, 2013
K221019 — Osteon Precision Milled Suprastructure · Implant Solutions Pty Ltd (Aka Osteon Medical) · Jul 5, 2022
K212676 — Osteon Precision Milled Suprastructure · Implant Solutions Pty Ltd (Osteon Medical) · Mar 3, 2022
K160207 — ATLANTIS ISUS Implant Suprastructures · Dentsply International, Inc. · Sep 21, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {2}------------------------------------------------ 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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K233083 Device Name Osteon Precision Milled Suprastructure #### Indications for Use (Describe) 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° {4}------------------------------------------------ - · 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) ## 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." {5}------------------------------------------------ ## 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, Australia Telephone: +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. {6}------------------------------------------------ 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 ● {7}------------------------------------------------ ● - 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. 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). | Description | Type A (For Removable Prosthesis) | | 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. {9}------------------------------------------------ ### 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. {10}------------------------------------------------ #### 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. {11}------------------------------------------------ ## Osteon Precision Milled Suprastructure | Table of Substantial Equivalence - Technological Characteristics | | | | | |------------------------------------------------------------------|--|--|--|--| |------------------------------------------------------------------|--|--|--|--| | Characteristic | Subject Device: Osteon Precision Milled Suprastructure Implant Solutions PTY LTD (aka Osteon Medical) | Primary Predicate Device: Osteon Precision Milled Suprastructure Implant Solutions PTY LTD (aka Osteon Medical) | Reference Device: Osteon Precision Milled Suprastructure, K212676 Implant Solutions PTY LTD (aka Osteon Medical) | Reference Device: KDG Abutments, K221381, Keystone Dental Inc. | Reference Device: Genesis ACTIVE Implant System, K223814, Keystone Dental Inc. | |--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications | 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 | 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, 4.8 mm, max 30° • DESS Dental Multi Unit Abutments, 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 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, max 30° | 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, 4.8 mm, max 30° • Dentium SuperLine® Abutments, 4.5-5.5 mm, max 30° • Keystone Multi Unit Abutment, 4.8 mm, 0° • Implant Direct GPS® Angled Abutment, 5.0 mm, max 30° • MIS Multi-unit Abutments, 4.8 mm • 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 Multi Unit | KDG Abutments are pre- manufactured prosthetic components for direct connection to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The KDG-Osteon Precision Milled Suprastructure is indicated for attachment to KDG Abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The KDG-Osteon Precision Milled Suprastructure is intended for attachment to a minimum of two (2) abutments. | The Genesis ACTIVE Implant System is intended for use in single-stage or two-stage surgical procedures for replacing single or multiple missing teeth in partially or fully edentulous mandibles and maxillae. The Genesis ACTIVE Implant System supports single or multiple- unit restorations to re- establish patient chewing function and esthetics. Genesis ACTIVE implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket. Immediate function may be achieved when good primary stability is established, and appropriate occlusal loading is applied. All digitally designed custom abutments for use with Genesis ACTIVE Implant System implants are to be sent to a Keystone Dental validated milling center for manufacture. The KDG-Osteon Precision Milled Suprastructure is indicated for attachment to the Genesis ACTIVE Multi-Unit abutments in the treatment of | | Characteristic | Subject Device: Osteon Precision Milled Suprastructure Implant Solutions PTY LTD (aka Osteon Medical) | Primary Predicate Device: Osteon Precision Milled Suprastructure Implant Solutions PTY LTD (aka Osteon Medical) | Reference Device: Osteon Precision Milled Suprastructure, K212676 Implant Solutions PTY LTD (aka Osteon Medical) | Reference Device: KDG Abutments, K221381, Keystone Dental Inc. | Reference Device: Genesis ACTIVE Implant System, K223814, Keystone Dental Inc. | | | • 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 OsseoSpeed™ • T Series - Dentsply Friadent® Frialit/Xive® | • Keystone Multi Unit Abutment, 4.8 mm, 0° • Implant Direct GPS® Angled Abutment, 5.0 mm, max 30° • MIS Multi-unit Abutments, 4.8 mm • 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 30° • 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, 4.8mm, 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° • 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, | • Nobel Biocare Multi Unit Abutment, 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 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° Zimmer Angled Tapered Abutments, 4.5 mm, max 30° | | partially or fully edentulous jaws for the purpose of restoring chewing function. The KDGOsteon Precision Milled Suprastructure is intended for attachment to a minimum of two (2) abutments. | | Characteristic | Subject Device: Osteon Precision Milled Suprastructure Implant Solutions PTY LTD (aka Osteon Medical) | Primary Predicate Device: Osteon Precision Milled Suprastructure Implant Solutions PTY LTD (aka Osteon Medical) | Reference Device: Osteon Precision Milled Suprastructure, K212676 Implant Solutions PTY LTD (aka Osteon Medical) | Reference Device: KDG Abutments, K221381, Keystone Dental Inc. | Reference Device: Genesis ACTIVE Implant System, K223814, Keystone Dental Inc. | | | • 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, | 0° • Piccolo Implants, 0° • External Hex Implants, max 30° • Straumann® BLX Screw Retained Abutment, 4.6 mm, max30° • Straumann® Screw Retained Abutment, 4.6 mm, max 30° • Zimmer Angled Tapered Abutments, 4.5 mm, max 30° | | | | | Characteristic | Subject Device: Osteon Precision Milled Suprastructure Implant Solutions PTY LTD (aka Osteon Medical) | Primary Predicate Device: Osteon Precision Milled Suprastructure Implant Solutions PTY LTD (aka Osteon Medical) | Reference Device: Osteon Precision Milled Suprastructure, K212676 Implant Solutions PTY LTD (aka Osteon Medical) | Reference Device: KDG Abutments, K221381, Keystone Dental Inc. | Reference Device: Genesis ACTIVE Implant System, K223814, Keystone Dental Inc. | | | 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 Material | Titanium alloy Ti-6Al- 4V | Titanium alloy Ti-6Al- 4V | Titanium alloy Ti-6Al- 4V | Grade 23 Titanium Alloy, No modified surface | Titanium alloy Ti-6Al- 4V | | Design/Technology | CAD/CAM milling from single milling blanks. | CAD/CAM milling from single milling blanks. | CAD/CAM milling from single milling blanks. | CAD/CAM milling | CAD/CAM milling | | Design/Construction | Patient specific/ machined…