Neoss Individual Prosthetics

K211396 · Neoss, Ltd. · NHA · May 17, 2022 · Dental

Device Facts

• Record ID: K211396
• Device Name: Neoss Individual Prosthetics
• Applicant: Neoss, Ltd.
• Product Code: NHA · Dental
• Decision Date: May 17, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Neoss Individual Prosthetics are designed to be connected to Neoss Implants and intended for use as an aid in prosthetic rehabilitation. All digitally designed CAD/CAM customizations for the Neoss Individual Abutments are only intended to be sent to and manufactured by an FDA registered and Neoss approved milling facility. Digital designs for Individual Bars/Bridges are sent to Neoss.

Device Story

Neoss Individual Prosthetics are patient-specific dental implant abutments, bridges, and bars; used to support single or multi-unit restorations on Neoss implants. Clinicians or dental technicians design the patient-specific shapes using CAD/CAM software; designs are verified by Neoss or an approved milling facility. Devices are manufactured via milling from titanium grade 4 (ASTM F67) or Ti-6Al-4V alloy (ASTM F136) blanks. Finished prosthetics are attached to implants using Neo Abutment screws and screwdrivers at specified torques. Used in dental clinics; operated by licensed clinicians or technicians. Output is a custom prosthetic component that restores chewing function and aesthetics for the patient.

Clinical Evidence

Bench testing only. Evidence includes engineering and dimensional analysis, and static/dynamic compression-bending testing per ISO 14801. Biocompatibility is supported by existing data for materials (ASTM F67/F136) and risk management per ISO 10993-1:2018. Sterilization validation performed using worst-case configurations.

Technological Characteristics

Materials: Titanium grade 4 (ASTM F67) or Ti-6Al-4V alloy (ASTM F136). Interfaces: SP (4.0mm) and NP (3.5mm) platforms. Manufacturing: CAD/CAM milling. Sterilization: Non-sterile (validated per ISO 17665-1). Connectivity: Digital design files sent to milling facility.

Indications for Use

Indicated for use as an aid in prosthetic rehabilitation for patients requiring single tooth or multi-unit prosthetic restorations supported by Neoss dental implants.

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

• Neoss Ltd., K043195 Neo Implant System

Reference Devices

• Neoss Ltd., K071838 Neoss Various Titanium Abutments
• Neoss Ltd., K081851 Neoss Access Abutment
• Neoss Ltd., K090452 Neoss Implant System 3.25
• Neoss Ltd., K150669 Neoss TiBase and CoCr Abutments
• Elos Medtech Pinol A/S, K192457 Elos Accurate® Customized Abutment
• Panthera Dental Inc., K173466 Panthera Dental Milled Bars

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.

Neoss Ltd % Cherita James Regulatory Consultant M Squared Associates Inc. 127 West 30th Street, Floor 9 New York, New York 10001

Re: K211396

Trade/Device Name: Neoss Individual Prosthetics Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 19, 2022 Received: April 21, 2022

### Dear Cherita James:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

K211396

Device Name

Neoss Individual Prosthetics

#### Indications for Use (Describe)

Neoss Individual Prosthetics are designed to be connected to Neoss Implants and intended for use as an aid in prosthetic rehabilitation.

All digitally designed CAD/CAM customizations for the Neoss Individual Abutments are only intended to be sent to and manufactured by an FDA registered and Neoss approved milling facility. Digital designs for Individual Bars/Bridges are sent to Neoss.

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

| <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------------------|
| <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

{3}------------------------------------------------

## 510(K) SUMMARY

The following information is provided as required by 21 CFR § 807.87 for the Neoss Individual Prosthetics 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.

- Sponsor: Neoss Ltd Windsor House Cornwall Road Harrogate, HG1 2PW, UK Establishment Registration Number: 3005846524
- Contact: Cherita James M Squared Associates, Inc. 127 West 30th St 9th Floor New York, New York 10001 Ph: 347-954-0624 Fax: [phone] E-mail: [e-mail]

Date of Submission: May 17, 2022

Proprietary Name: Neoss Individual Prosthetics

Common Name: Dental Implant Abutment

Regulatory Class: II

Regulation: 872.3630

Product Code: NHA

Predicate Device(s): Primary predicate: Neoss Ltd., K043195 Neo Implant System (Neo Mono and Multi abutments, Bar Abutments,)

Reference predicates:

- Neoss Ltd., K071838 Neoss Various Titanium Abutments cleared (Neoss -Prepable Abutments);
- Neoss Ltd., K081851 Neoss Access Abutment (Straight and Angled Multi Abutments)
- Neoss Ltd., K090452 Neoss Implant System 3.25 cleared under; (Neoss Implant -System Ø3.25 Abutments)

{4}------------------------------------------------

- -Neoss Ltd., K150669 Neoss TiBase and CoCr Abutments; (Crystaloc Screw)
- -Elos Medtech Pinol A/S, K192457 Elos Accurate® Customized Abutment
- -Panthera Dental Inc., K173466 Panthera Dental Milled Bars

Indications for Use: Neoss Individual Prosthetics are designed to be connected to Neoss Implants and intended for use as an aid in prosthetic rehabilitation. All digitally designed CAD/CAM customizations for the Neoss Individual Abutments are only intended to be sent to and manufactured by an FDA registered and Neoss approved milling facility. Digital designs for Individual Bars/Bridges are sent to Neoss.

Device Description: Neoss Individual Prosthetics are endosseous dental implant abutments used to support single tooth restorations (Abutment) or multi-unit prosthetic restorations (Abutment, Bridge or Bar) on Neoss Implants on implant level or abutment level. Neoss Individual Prosthetics are generally produced with straight screw channels (SSC) to be used with Neo Abutment screws and Neo Screwdrivers. Neoss Individual Prosthetics also features the option to customize the angulation of the screw access channel. Compatible Neoss Implant System includes two implant/prosthetic interfaces, i.e. platforms, SP and NP. Neoss Implant System also includes one abutment/prosthetic interface. This platform is called Access with a platform diameter of 4.0 mm.

| | Neoss Implants SP<br>(K043195, K083561,<br>K113376) | Neoss Implants NP<br>(K090452) | Neoss Access<br>Abutments<br>(K081851) |
|-------------------------------|-----------------------------------------------------|--------------------------------|----------------------------------------|
| Neoss Individual<br>Abutments | Compatible | Compatible | Not compatible |
| Neoss Individual<br>Bridges | Compatible | Compatible | Compatible |
| Neoss Individual Bars | Compatible | Compatible | Compatible |

Neoss Individual Abutments are patient specific and are manufactured from Abutment Blanks. Blanks are hollow metal cylinders available in either Titanium (grade 4 ASTM F67 or Ti-6A1-4V alloy ASTM F136). The blank has a precision milled prefabricated Neoss® implant connection (NeoLoc®) for the SP and NP platforms. The top part of the blanks can be milled to a patient-specific shape. The design of the patient-specific shape of the abutment is performed by a licensed clinician or dental technician and then verified for compliance with the abutment design limits by Neoss or a Neoss approved milling facility. Following the verification of the design the CAD/CAM processing and production of the individual prosthetics is conducted by Neoss or a Neoss approved milling facility.

The finished abutment is attached to a Neoss Implant with a screw and a screwdriver at a set torque that depends on the platform.

{5}------------------------------------------------

Neoss Individual Bridges are patient specific and are manufactured from bulk material in Titanium (Ti-6Al-4V alloy ASTM F136).The posts that attach to Neoss Implants, optionally with intermediate Neoss Access Abutments, have a pre-defined interface, SP, NP or Access, to assure compatibility. The design of the patient-specific shape of the bridges is performed by a licensed clinician or dental technician and then verified for compliance with the bridge design limits by Neoss. Following the approval of the design, CAD/CAM processing and production of the individual prosthetics is conducted by Neoss. The implant interface is manufactured to Neoss specification to facilitate compatibility with Neoss platforms SP, NP or Access.

The finished bridge is attached to a Neoss Implant or Neoss Access abutment with a screw and a screwdriver at a set torque that depends on the platform.

Neoss Individual Bars are patient specific and are manufactured from bulk material in Titanium (Ti-6Al-4V alloy ASTM F136). The posts that attach to Neoss Implants, optionally with intermediate Neoss Access Abutments, have a pre-defined interface to assure compatibility. The bars are designed for use with full or partial removable dentures and can be made with pre-defined design features making them compatible with commercially available precision attachments. The design of the patient-specific shape of the bars is performed by a licensed clinician or dental technician and then verified for compliance with the bar design limits by Neoss. Following the approval of the design, CAD/CAM processing and production of the individual prosthetics is conducted by Neoss. The implant interface is manufactured to Neoss specification to facilitate compatibility with Neoss platforms SP, NP or Access.

The finished bar is attached to a Neoss Implant or Neoss Access abutment with a screw and a screwdriver at a set torque that depends on the platform.

### Performance Testing

The Neoss Individual Prosthetics conform to the following standards:

| Standard | Recognition<br>Number |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| ISO 10993-1 Fifth edition 2018-08, Biological evaluation of medical devices - Part<br>1: Evaluation and testing within a risk management process | 2-258 |
| ISO 14801 Third edition 2016-11-01, Dentistry-Implants-Dynamic fatigue test for<br>endosseous dental implants. | 4-259 |
| ISO 14801 Second edition 2007-11-15, Dentistry - Implants-Dynamic fatigue test<br>for endosseous dental implants | 4-195 |
| ISO 17665-1, 2006, Sterilization of healthcare products — Moist heat — Part 1:<br>Requirements for the development, validation and routine control of a sterilization<br>process for medical devices | 14-333 |

{6}------------------------------------------------

This non-clinical testing data was submitted to demonstrate substantial equivalence:

- engineering analysis and dimensional analysis and; -
- static and dynamic compression-bending testing according to ISO 14801 -

Dentistry-Implants-Dynamic fatigue test for endosseous dental implants. Biocompatibility: No new biocompatibility testing has been performed, as the subject devices are substantially equivalent to Neo Abutment (K043195) with regards to materials and processing. Biological evaluation reports, cover all materials (titanium grade 4, alloyed titanium) included in Neoss medical devices. The evaluation done within a risk management process as described in ISO 10993-1:2018 is provided for final products, and therefore takes all manufacturing steps into account.

Sterilization validation: Neoss has determined that the Neoss Ti Abutment Blank ( K071838) as the worst case product and therefore the validation is applicable also for Neoss Individual Bars and Neoss Individual Bridges, and worst case configuration, with an unprepared Titanium Abutment blank (K150669- Ti Ø3.25 Ø10 x 15) applicable for Individual Abutments.

Clinical Data: Clinical data is not required to establish substantial equivalence in this submission.

### Substantial Equivalence

The claim of substantial equivalence of the Neoss Individual Prosthetics to the products identified above is based on the comparison of the intended use, product technical characteristics, performance characteristics and product handling.

| Characteristic | Indications for use |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject device<br>Neoss Individual<br>Prosthetics | Neoss Individual Prosthetics are designed to be connected to Neoss Implants and<br>intended for use as an aid in prosthetic rehabilitation.<br>All digitally designed CAD/CAM customizations for the Neoss Individual<br>Abutments are only intended to be sent to and manufactured by an FDA<br>registered and Neoss approved milling facility. Digital designs for Individual<br>Bars/Bridges are sent to Neoss. |
| Primary Predicate<br>Device<br>K043195 Neo<br>Implant System | The Neo Abutments includes a set of components that are intended to function<br>on Neo implants or compatible external hex, Replace Select implants and<br>Straumann implants, as a base prosthetic construction. |
| Reference Predicate<br>Device | The Neoss Titanium Preparable Abutment 15°and 20° and Neoss Express<br>abutments are designed to be connected to the Neoss implant and are |

### Indications for Use

{7}------------------------------------------------

| K071838 Neoss<br>Various Titanium<br>Abutment | intended for use as an aid in prosthetic rehabilitation. | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Reference Predicate<br>Device<br>K081851 Neoss<br>Access Abutment | The Neoss Access Abutments are designed to be connected to the Neoss<br>implants and intended for use as an aid in prosthetic rehabilitation.<br>Neoss Access Abutments represent a two piece abutment system and are<br>designed to be connected to the Neoss implants, to receive another abutment or<br>framework and intended for use as an aid in multiple-unit prosthetic<br>rehabilitation such as dental bridge restorations. | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Reference Predicate<br>Device<br>K090452 Neoss<br>Implant System 3.25 | The Neoss Implant Ø3.25 abutments are designed to be connected to the Neoss<br>implants and intended for use as an aid in prosthetic rehabilitation. | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Reference Predicate<br>Device<br>K150669 Neoss<br>TiBase and CoCr<br>Abutments | Neoss TiBase:<br>Neoss Abutments are designed to be connected to the Neoss Implants and<br>intended for use as an aid in prosthetic rehabilitation.<br>The Neoss TiBase is compatible with the Sirona Dental System inCoris ZI Meso<br>L. All digitally designed copings and/or crowns for use with the Neoss TiBase<br>Abutments are to be designed and milled using the Sirona Dental CAD/CAM<br>System. | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Reference Predicate<br>Device<br>K192457<br>Elos Accurate®<br>Customized<br>Abutment | The Elos Accurate® Customized Abutments are intended for attaching to<br>dental implants in order to provide basis for single or multiple tooth<br>prosthetic restorations. The Elos Accurate® Customized Abutment will be<br>attached to a dental implant using the included Elos Prosthetic screw. The Elos<br>Accurate® Customized Abutments are compatible with the implant systems<br>listed in table 1:<br>Elos Accurate Customized<br>Abutment – Model Type | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Elos Accurate Customized<br>Abutment – Model Type Platform<br>compatibility Platform<br>diameter<br>[mm] Implant<br>Body<br>diameter<br>[mm] AB-NBR35 Nobel Replace NP 3.5 3.5 AB-NBA30 Nobel CC 3.0 3.3 AB-NBA43 Nobel CC RP 3.9 4.3 & 5 AB-NBA60 Nobel CC WP 5.1 5.5 AB-SBO33 Straumann Bone<br>Level 3.3 3.3 AB-SBO41 Straumann Bone<br>Level 4.1 & 4.8 4.1 & 4.8 All digitally designed CAD/CAM customizations for the Elos Accurate®<br>Customized Abutments are only intended to be sent and manufactured at a FDA<br>registered Elos Medtech approved milling facility. | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Reference Predicate<br>Device<br>K173466<br>Panthera Dental<br>Milled Bars | The Panthera Dental Milled Bar is indicated for use as an accessory to an<br>endosseous dental implant to support a prosthetic device in a partially or<br>edentulous patient for purpose of restoring chewing function. It is intended<br>for use to support multiple tooth prostheses in the mandible or maxilla. The<br>prostheses can be screw retained. The Panthera Dental Milled Bars are indicated<br>for compatibility with the Zimmer Tapered Screw-Vent System for sizes 3.5 and<br>4.5. | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

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

## Predicate and Reference Device Comparisons

## Neoss Individual Abutments

| Characteristic | Neo Implant<br>System | Neoss<br>Titanium<br>Various<br>Abutments | Neoss Access<br>Abutment | Neoss Implant<br>3.25 Prepable<br>Abutments | Neoss TiBase<br>and CoCr<br>Abutment | Elos | Neoss Individual<br>Prosthetics<br>Subject device | Substantially<br>equivalent |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K043195 | K071838 | K081851 | K090452 | K150669 | K192457 | To be determined | - |
| Types of<br>abutments | Abutments for<br>single tooth or<br>cemented<br>bridge | Abutments<br>for single<br>tooth or<br>cemented<br>bridge | Multi-unit<br>abutments<br>(incorporated<br>into bridges)<br>Bar Abutments<br>(welded or<br>soldered to bar<br>constructions) | Abutments for<br>single tooth or<br>cemented<br>bridge | Abutments<br>for single<br>tooth or<br>cemented<br>bridge | Abutments<br>for single<br>tooth or<br>cemented<br>bridge | Abutments for single<br>tooth or cemented<br>bridge | Yes |
| Characteristics | Customizable<br>to desired<br>shape | Customizable<br>to desired<br>shape | Multi-unit<br>abutment with<br>set of<br>customizable<br>and cast-able<br>bridge and bar<br>abutments | Customizable<br>to desired shape | Customizable<br>to desired<br>shape | Customizable<br>to desired<br>shape | Customizable to<br>desired shape | Yes |
| Characteristic | Neo Implant<br>System | Neoss<br>Titanium<br>Various<br>Abutments | Neoss Access<br>Abutment | Neoss Implant<br>3.25 Prepable<br>Abutments | Neoss TiBase<br>and CoCr<br>Abutment | Elos | Neoss Individual<br>Prosthetics<br>Subject device | Substantially<br>equivalent |
| 510(k) | K043195 | K071838 | K081851 | K090452 | K150669 | K192457 | To be determined | |
| Material | Abutments:<br>Titanium<br>grade 4.<br>ASTM F67<br>Titanium<br>alloy, ASTM<br>F136<br>Screws:<br>Titanium<br>alloy, ASTM<br>F136<br>Gold alloy | Abutments:<br>Titanium<br>grade 4,<br>ASTM F67<br>Titanium<br>alloy, ASTM<br>F136<br>Screws:<br>Titanium<br>alloy, ASTM<br>F136<br>Gold alloy | Abutments:<br>Titanium alloy,<br>ASTM F136<br>Bridge/Bar<br>Posts<br>Screws:<br>Titanium alloy,<br>ASTM F136 | Abutments:<br>Titanium grade<br>4, ASTM F67<br>Titanium alloy,<br>ASTM F136<br>Screws:<br>Titanium alloy,<br>ASTM F136 | Abutments:<br>Titanium<br>alloy, ASTM<br>F136<br>CoCr alloy,<br>ASTM F1537<br>Screws:<br>Titanium<br>alloy, ASTM<br>F136 | Elos<br>Accurate®<br>Customized<br>Abutments:<br>Titanium<br>Alloy 6Al-4V<br>ELI, medical<br>grade 5<br>Elos<br>Prosthetic<br>screws:<br>Titanium<br>Alloy 6Al-4V<br>ELI, medical<br>grade 5 | Abutment:<br>Titanium grade 4.<br>ASTM F67<br>Titanium alloy,<br>ASTM F136<br>Screws:<br>Titanium alloy,<br>ASTM F136 | Yes.<br>The materials used<br>have been used in the<br>primary predicate<br>device |
| Surface finish | Abutments:<br>Non-coated<br>Screws: Non-<br>coated | Abutments:<br>Non-coated<br>Screws: Non-<br>coated | Abutments:<br>Non-coated<br>Screws:<br>TiN/Au coated | Abutments:<br>Non-coated<br>Screws: Non-<br>coated | Abutments:<br>Non-coated<br>Screws:<br>TiN/Au<br>coated | Abutment:<br>Non-coated<br>Screws: Non-<br>coated<br>Medicarb<br>(DLC) | Abutment/Bar/Bridge:<br>Non-coated<br>Screws: TiN/Au<br>coated | Abutments/Bar/Bridge:<br>Yes.<br>Screw:<br>Yes. The coating is the<br>same as was<br>introduced with<br>K081851 and further<br>established with<br>K150669. |
| Platform<br>diameter | 4.0 mm (SP) | 4.0 mm (SP) | 4.0 mm (SP) | 3.5 mm (NP) | 4.0 mm (SP) | 3.5 - 5.1 | 4 mm (SP);<br>3.5 mm (NP) | Yes. SP is the same as<br>the primary predicate,<br>and NP is the same as<br>K090452 |
| Minimum post<br>height | 4 mm | 4 mm | Not defined | 4 mm | 4 mm | 4 mm | 4 mm | Yes |
| Characteristic | Neo Implant<br>System | Neoss<br>Titanium<br>Various<br>Abutments | Neoss Access<br>Abutment | Neoss Implant<br>3.25 Prepable<br>Abutments | Neoss TiBase<br>and CoCr<br>Abutment | Elos | Neoss Individual<br>Prosthetics<br>Subject device | Substantially<br>equivalent |
| 510(k) | K043195 | K071838 | K081851 | K090452 | K150669 | K192457 | To be determined | - |
| Gingival<br>height | Not defined | Not defined | Not defined | Not defined | 0-4mm | 0.5-5mm | 0.5-4mm | Yes. Within the<br>minimum (0mm) and<br>maximum (5mm) of<br>the predicate devices. |
| Minimum<br>thickness<br>(adjacent to<br>screw seating) | Not defined | 0.5 mm | Not defined | 0.5 mm | 0.4 mm | 0.4 mm | 0.5 mm | Yes |
| Abutment<br>Angulation | 0 - 20° | 0, °15° and<br>20° | 0-30° | 0, °15° and 20° | 0 - 20° | 0-30° | 0 - 30° | Yes |
| Abutment<br>connection | Internal<br>connection<br>with press-fit<br>of<br>interlocking<br>means | Internal<br>connection<br>with press-fit<br>of<br>interlocking<br>means | Internal<br>connection with<br>and without<br>interlocking<br>means | Internal<br>connection with<br>press-fit of<br>interlocking<br>means | Internal<br>connection<br>with press-fit<br>of<br>interlocking<br>means | Indexed | Internal connection<br>with press-fit of<br>interlocking means | Yes |
| Abutment<br>screw size | M2 Screw<br>(SP) | M2 Screw<br>(SP) | M2 Screw (SP) | M1.6 screw<br>(NP) | M2 screw<br>(SP) | Not defined | SP: M2 screw<br>NP: M1.6 screw | Yes |
| Screw Channel | Straight | Straight | 0-30° | Straight | Straight | Straight | 0 – 25° | Equivalent with<br>K081851 Access<br>Abutment. |
| Sterility | Non-sterile | Non-sterile | Sterile and<br>Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Yes |
| Digital CAD<br>Systems | Not specified | Not specified | Not specified | Not specified | Sirona system | 510(k)<br>cleared CAD<br>software | 510(k) cleared CAD<br>software | Yes |
| Characteristic | Neo Implant<br>System | Neoss<br>Titanium<br>Various<br>Abutments | Neoss Access<br>Abutment | Neoss Implant<br>3.25 Prepable<br>Abutments | Neoss TiBase<br>and CoCr<br>Abutment | Elos | Neoss Individual<br>Prosthetics<br>Subject device | Substantially<br>equivalent |
| 510(k) | K043195 | K071838 | K081851 | K090452 | K150669 | K192457 | To be determined | |
| Production | Turned and<br>Milled | Turned and<br>Milled | Turned and<br>Milled | Turned and<br>Milled | Turned and<br>Milled | Turned and<br>Milled | Turned and Milled | Yes |

{9}------------------------------------------------

{10}------------------------------------------------

{11}------------------------------------------------

## Neoss Individual Bridges and Bars

| Bridges and Bars<br>Characteristic | Neo Implant<br>System | Neoss Access<br>Abutment | Neoss Implant<br>3.25 Prepable<br>Abutments | Neoss TiBase | Panthera | Neoss Individual<br>Prosthetics<br>Subject device | Substantially equivalent |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K043195 | K081851 | K090452 | K150669 | K173466 | To be determined | - |
| Types of<br>prosthetics | Multi-unit<br>abutments<br>(incorporated<br>into bridges)<br>Bar Abutments<br>(welded or<br>soldered to bar<br>constructions) | Multi-unit<br>abutments<br>(incorporated<br>into bridges)<br>Bar Abutments<br>(welded or<br>soldered to bar<br>constructions) | Multi-unit<br>abutments<br>(incorporated<br>into bridges)<br>Bar Abutments<br>(welded or<br>soldered to bar<br>constructions) | Multi-unit<br>abutments<br>(incorporated<br>into bridges) | One-piece bar,<br>with integrated<br>abutment interfaces<br>(cylinders) | One-piece bridge with<br>integrated abutment<br>interfaces (posts)<br>One-piece bar, with<br>integrated abutment<br>interfaces (cylinders) | Yes |
| Characteristics | Customizable<br>to desired<br>shape | Multi-unit<br>abutment with<br>set of<br>customizable<br>and cast-able<br>bridge and bar<br>abutments | Customizable to<br>desired shape | Customizable<br>to desired<br>shape | Individually<br>designed for each<br>patient by order of<br>prescription. | Customizable to desired<br>shape | Yes |
| Bridges and Bars<br>Characteristic | Neo Implant<br>System | Neoss Access<br>Abutment | Neoss Implant<br>3.25 Prepable<br>Abutments | Neoss TiBase | Panthera | Neoss Individual<br>Prosthetics<br>Subject device | Substantially equivalent |
| 510(k) | K043195 | K081851 | K090452 | K150669 | K173466 | To be determined | |
| Material | Abutments:<br>Titanium alloy,<br>ASTM F136<br>Screws:<br>Titanium alloy,<br>ASTM F136<br>Gold alloy | Abutments:<br>Titanium alloy,<br>ASTM F136<br>Bridge/Bar<br>Posts<br>Screws:<br>Titanium alloy,<br>ASTM F136 | Abutments:<br>Titanium alloy,<br>ASTM F136<br>Screws:<br>Titanium alloy,<br>ASTM F136 | Abutments:<br>Titanium alloy,<br>ASTM F136<br>Screws:<br>Titanium alloy,<br>ASTM F136 | Titanium alloy | Bar/Bridge:<br>Titanium alloy, ASTM<br>F136<br>Screws:<br>Titanium alloy, ASTM<br>F136 | Yes.<br>The materials used have<br>been used in the primary<br>predicate device |
| Surface finish | Abutments:<br>Non-coated<br>Screws:<br>Non-coated | Abutments:<br>Non-coated<br>Screws:<br>TiN/Au coated | Abutments:<br>Non-coated<br>Screws:<br>Non-coated | Abutments:<br>Non-coated<br>Screws:<br>TiN/Au coated | Not defined | Bar/Bridge:<br>Non-coated<br>Screws:<br>TiN/Au coated | Abutments/Bar/Bridge:<br>Yes.<br>Screw: The coating is the<br>same as was introduced<br>with K081851 and<br>further established with<br>K150669. |
| Platform/Cylinder<br>diameter | 4.0 mm (SP) | 4.0 mm (SP) | 3.5 mm (NP) | 4.0 mm (SP) | 3 – 8 mm | 4 mm (SP);<br>3.5 mm (NP) | Yes, SP is the same as<br>the primary predicate,<br>and NP is the same as<br>K090452 |
| Minimum<br>post/cylinder<br>height | 4 mm | Not defined | 4 mm | 4 mm | 0 mm | 5 mm | Yes |
| Minimum<br>thickness<br>(adjacent to screw<br>seating) | Not defined | Not defined | 0.5 mm | 0.4 mm | Not defined | 1.0 mm | Yes |
| Bridges and Bars<br>Characteristic | Neo Implant<br>System | Neoss Access<br>Abutment | Neoss Implant<br>3.25 Prepable<br>Abutments | Neoss TiBase | Panthera | Neoss Individual<br>Prosthetics<br>Subject device | Substantially equivalent |
| 510(k) | K043195 | K081851 | K090452 | K150669 | K173466 | To be determined | - |
| Bridge/Bar<br>connection | Internal<br>connection with<br>no interlocking<br>means | Internal<br>connection with<br>no interlocking<br>means | Internal<br>connection with<br>no interlocking<br>means | Internal<br>connection<br>with no<br>interlocking<br>means | Not defined | Internal connection with<br>no interlocking means | Yes |
| Abutment screw<br>size | M2 Screw (SP) | M2 Screw (SP) | M1.6 screw (NP) | M2 screw (SP) | Not defined | SP: M2 screw<br>NP: M1.6 screw | Yes |
| Screw Channel | Straight | 0-30° | Straight | Straight | Not defined | 0 - 25° | Equivalent with K081851<br>Access Abutment. |
| Minimum cross<br>sections between<br>posts/cylinders | Not defined | Not defined | Not defined | Not defined | Height 2.5mm<br>Width 1.5mm | Height 3 mm<br>Width 2 mm | Yes. Subject device is<br>substantially equivalent<br>to predicate devices. |
| Span between<br>cylinders | Not defined | Not defined | Not defined | Not defined | 0-30 mm | 0-30 mm | Yes. Subject device is<br>substantially equivalent<br>to predicate devices. |
| Minimum cross<br>sections of<br>cantilever | Not defined | Not defined | Not defined | Not defined | Height 2.5mm<br>Width 1.5mm | Height 5 mm<br>Width 3 mm | Yes. Subject device is<br>substantially equivalent<br>to predicate devices. |
| Maximum<br>cantilever length | Not defined | Not defined | Not defined | Not defined | 30 mm | Full arch: 15 mm<br>Partial: 6 mm | Yes. Subject device is<br>substantially equivalent<br>to predicate devices. |
| Sterility | Non-sterile | Sterile and<br>Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Yes |
| Production | Turned and<br>Milled | Turned and<br>Milled | Turned and<br>Milled | Turned and<br>Milled | Milled | Milled | Yes |

{12}------------------------------------------------

{13}------------------------------------------------

{14}------------------------------------------------

#### Conclusion

Neoss Individual Prosthetics utilize the same materials, dimensions, platform sizes (SP, NP), attace finishes as previously cleared Neoss devices. Angulations and minimum heights are within the same specifications are within the same range as the predicate and reference devices identified. The indications and predicate/reference devices, while differing in language used, are all abutnents, bars, and bridges intended rehabilitation. The process of determining patient specific requirements and device processing is comparable to other customized reference devices. They are compatible with currently markets. The data presented in this submission demonstrates that the proposed devices are substantially equivalent with respect to fatigue testing performance and intended use. The proposed devices perform as well as the legally marketed predicate devices. Furthermore, the proposed devices do not pose any new or increased risks as compared to the legally marketed predicate devices the subject and predicate device would not render the device NSE, affectiveness, or raise different questions of safety and effectiveness.