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 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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "Neoss Individual Prosthetics". This document focuses on demonstrating substantial equivalence to already legally marketed predicate devices, rather than presenting a study to prove novel acceptance criteria for a new device type.

Therefore, many of the requested details about acceptance criteria, device performance from a new study, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training data provenance are not applicable to this type of regulatory submission.

The document primarily provides a comparison of characteristics between the subject device and its predicates to argue for substantial equivalence.

Here's an analysis based on the provided text, indicating where information is present and where it is not applicable for this type of submission:

1. Table of acceptance criteria and the reported device performance

This document does not define new "acceptance criteria" for novel performance. Instead, it compares the characteristics of the subject device (Neoss Individual Prosthetics) to several predicate devices. The "performance" is implicitly demonstrated through conformance to established standards and the side-by-side comparison with predicate devices.

Acceptance Criteria (Implied by Predicate Comparison) and Reported Device Performance:

Characteristic	Implied Acceptance Criteria (via Predicate Ranges/Characteristics)	Reported Device Performance (Neoss Individual Prosthetics)	Substantially Equivalent?
Abutments:
Types of abutments	Abutments for single tooth or cemented bridge (based on predicates like K043195, K071838, K090452, K150669, K192457)	Abutments for single tooth or cemented bridge	Yes
Characteristics	Customizable to desired shape	Customizable to desired shape	Yes
Material	Titanium grade 4, ASTM F67; Titanium alloy, ASTM F136; TiN/Au coated screws (based on predicates)	Abutment: Titanium grade 4, ASTM F67; Titanium alloy, ASTM F136. Screws: Titanium alloy, ASTM F136	Yes (materials used are in primary predicate)
Surface finish	Non-coated abutments; Non-coated or TiN/Au coated screws	Abutment/Bar/Bridge: Non-coated. Screws: TiN/Au coated	Yes (screw coating same as K081851 and K150669)
Platform diameter	3.5 mm (NP) and 4.0 mm (SP) (based on K043195, K071838, K081851, K090452, K150669, K192457)	4 mm (SP); 3.5 mm (NP)	Yes (SP same as primary predicate, NP same as K090452)
Minimum post height	4 mm (based on K043195, K071838, K090452, K150669, K192457)	4 mm	Yes
Gingival height	0-5 mm range (based on K150669 (0-4mm) and K192457 (0.5-5mm))	0.5-4 mm	Yes (within minimum/maximum of predicates)
Minimum thickness (adjacent to screw seating)	0.4-0.5 mm (based on K071838, K090452, K150669, K192457)	0.5 mm	Yes
Abutment Angulation	0-30° (based on predicates like K081851 and K192457)	0-30°	Yes
Abutment connection	Internal connection with press-fit of interlocking means or indexed	Internal connection with press-fit of interlocking means	Yes
Abutment screw size	M2 Screw (SP) and M1.6 screw (NP) (based on predicates)	SP: M2 screw; NP: M1.6 screw	Yes
Screw Channel	Straight or 0-30° (based on predicates like K081851)	0-25°	Equivalent with K081851 Access Abutment
Sterility	Non-sterile (similar to most predicates, although K081851 had sterile/non-sterile)	Non-sterile	Yes
Digital CAD Systems	510(k) cleared CAD software (similar to K192457, K150669)	510(k) cleared CAD software	Yes
Production	Turned and Milled	Turned and Milled	Yes
Bridges & Bars:
Types of prosthetics	Multi-unit abutments (incorporated into bridges), Bar Abutments (welded or soldered to bar constructions), One-piece bar with integrated abutment interfaces (based on predicates)	One-piece bridge with integrated abutment interfaces (posts); One-piece bar, with integrated abutment interfaces (cylinders)	Yes
Characteristics	Customizable to desired shape, Individually designed	Customizable to desired shape	Yes
Material	Titanium alloy, ASTM F136; Titanium alloy, ASTM F136 screws (based on predicates)	Bar/Bridge: Titanium alloy, ASTM F136. Screws: Titanium alloy, ASTM F136	Yes (materials used are in primary predicate)
Surface finish	Non-coated; TiN/Au coated screws	Bar/Bridge: Non-coated. Screws: TiN/Au coated	Yes (screw coating same as K081851 and K150669)
Platform/Cylinder diameter	3-8 mm (based on predicates)	4 mm (SP); 3.5 mm (NP)	Yes (SP same as primary predicate, NP same as K090452)
Minimum post/cylinder height	0-4 mm (based on predicates)	5 mm	Yes
Minimum thickness (adjacent to screw seating)	0.4-1.5 mm (based on predicates)	1.0 mm	Yes
Bridge/Bar connection	Internal connection with no interlocking means	Internal connection with no interlocking means	Yes
Abutment screw size	M2 Screw (SP) and M1.6 screw (NP)	SP: M2 screw; NP: M1.6 screw	Yes
Screw Channel	Straight or 0-30°	0-25°	Equivalent with K081851 Access Abutment
Minimum cross-sections between posts/cylinders	(Predicate K173466: Height 2.5mm, Width 1.5mm)	Height 3 mm, Width 2 mm	Yes
Span between cylinders	0-30mm (Predicate K173466)	0-30 mm	Yes
Minimum cross-sections of cantilever	(Predicate K173466: Height 2.5mm, Width 1.5mm)	Height 5 mm, Width 3 mm	Yes
Maximum cantilever length	30 mm (Predicate K173466)	Full arch: 15 mm; Partial: 6 mm	Yes
Sterility	Non-sterile (consistent with most predicates)	Non-sterile	Yes
Production	Turned and Milled	Milled	Yes
Performance Testing (Common for all)
Conformance Standards	ISO 10993-1, ISO 14801, ISO 17665-1	Conforms to these standards	Yes
Biocompatibility	Equivalent to Neo Abutment (K043195) due to same materials and processing. Evaluation within a risk management process per ISO 10993-1.	No new biocompatibility testing performed; substantial equivalence claimed based on predicate.	Yes
Sterilization validation	Neoss Ti Abutment Blank (K071838) as worst case, applicable to Individual Bars/Bridges. Unprepared Titanium Abutment blank (K150669) for Individual Abutments.	Validation applicable to subject devices.	Yes
Dynamic fatigue testing	According to ISO 14801	Static and dynamic compression-bending testing according to ISO 14801	Yes
Other Testing	Engineering analysis and dimensional analysis	Engineering analysis and dimensional analysis	Yes

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This is a 510(k) submission showing substantial equivalence, not a clinical trial or performance study requiring a test set of patient data with a specific sample size. The "testing data" refers to non-clinical performance and material characterization.
The "Performance Testing" section mentions "engineering analysis and dimensional analysis" and "static and dynamic compression-bending testing according to ISO 14801." These are laboratory-based, non-clinical tests typically performed on a sample of manufactured devices (e.g., a batch or specific configurations), not on a "test set" of patient data. Specific sample sizes for these engineering tests are not provided in this summary.
Data Provenance: The document does not specify the country of origin for the non-clinical testing data, nor whether it's retrospective or prospective. It's implied to be internal testing by Neoss Ltd, based in the UK.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. As there is no "test set" for diagnostic performance or interpretation of patient data, there are no experts establishing ground truth in this context. The "ground truth" for the device's technical specifications is based on engineering principles and international standards.

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

Not Applicable. No human interpretation of a "test set" is involved in this type of submission.

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 dental prosthetic (abutments, bridges, bars), not an AI diagnostic or assistive tool. Therefore, MRMC studies are not relevant.

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

Not Applicable. This device is a physical dental prosthetic, not an algorithm.

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

The "ground truth" for this device's performance is adherence to established international standards (ISO 10993-1, ISO 14801, ISO 17665-1) and comparison of technical specifications, materials, and intended use with previously cleared predicate devices. It's essentially engineering specifications and established regulatory benchmarks.

8. The sample size for the training set

Not Applicable. This is a physical medical device, not a machine learning algorithm. There is no "training set" in the context of an AI model.
However, the design and manufacturing process involves digital CAD/CAM customizations. While not a "training set" in the AI sense, the designs are verified for compliance against design limits by Neoss or an approved milling facility. The accumulated knowledge and design rules used for this verification could be considered analogous to a "training" data in a very broad sense, but it's not a formal dataset for training an AI.

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

Not Applicable. As there is no training set for an AI model, this question does not apply.
For the CAD/CAM design process, the "ground truth" for the designs would be engineering specifications, anatomical considerations, and clinical requirements, validated by qualified personnel within Neoss or approved facilities.

Summary

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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.

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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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)
-------------------------------------------------

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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: 702-562-9797 E-mail: CJames@MSquaredAssociates.com

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)

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-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(K043195, K083561,K113376)	Neoss Implants NP(K090452)	Neoss AccessAbutments(K081851)
Neoss IndividualAbutments	Compatible	Compatible	Not compatible
Neoss IndividualBridges	Compatible	Compatible	Compatible
Neoss Individual Bars	Compatible	Compatible	Compatible

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

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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.

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	RecognitionNumber
ISO 10993-1 Fifth edition 2018-08, Biological evaluation of medical devices - Part1: Evaluation and testing within a risk management process	2-258
ISO 14801 Third edition 2016-11-01, Dentistry-Implants-Dynamic fatigue test forendosseous dental implants.	4-259
ISO 14801 Second edition 2007-11-15, Dentistry - Implants-Dynamic fatigue testfor endosseous dental implants	4-195
ISO 17665-1, 2006, Sterilization of healthcare products — Moist heat — Part 1:Requirements for the development, validation and routine control of a sterilizationprocess for medical devices	14-333

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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 deviceNeoss IndividualProsthetics	Neoss Individual Prosthetics are designed to be connected to Neoss Implants andintended for use as an aid in prosthetic rehabilitation.All digitally designed CAD/CAM customizations for the Neoss IndividualAbutments are only intended to be sent to and manufactured by an FDAregistered and Neoss approved milling facility. Digital designs for IndividualBars/Bridges are sent to Neoss.
Primary PredicateDeviceK043195 NeoImplant System	The Neo Abutments includes a set of components that are intended to functionon Neo implants or compatible external hex, Replace Select implants andStraumann implants, as a base prosthetic construction.
Reference PredicateDevice	The Neoss Titanium Preparable Abutment 15°and 20° and Neoss Expressabutments are designed to be connected to the Neoss implant and are

Indications for Use

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K071838 NeossVarious TitaniumAbutment	intended for use as an aid in prosthetic rehabilitation.
Reference PredicateDeviceK081851 NeossAccess Abutment	The Neoss Access Abutments are designed to be connected to the Neossimplants and intended for use as an aid in prosthetic rehabilitation.Neoss Access Abutments represent a two piece abutment system and aredesigned to be connected to the Neoss implants, to receive another abutment orframework and intended for use as an aid in multiple-unit prostheticrehabilitation such as dental bridge restorations.
Reference PredicateDeviceK090452 NeossImplant System 3.25	The Neoss Implant Ø3.25 abutments are designed to be connected to the Neossimplants and intended for use as an aid in prosthetic rehabilitation.
Reference PredicateDeviceK150669 NeossTiBase and CoCrAbutments	Neoss TiBase:Neoss Abutments are designed to be connected to the Neoss Implants andintended for use as an aid in prosthetic rehabilitation.The Neoss TiBase is compatible with the Sirona Dental System inCoris ZI MesoL. All digitally designed copings and/or crowns for use with the Neoss TiBaseAbutments are to be designed and milled using the Sirona Dental CAD/CAMSystem.
Reference PredicateDeviceK192457Elos Accurate®CustomizedAbutment	The Elos Accurate® Customized Abutments are intended for attaching todental implants in order to provide basis for single or multiple toothprosthetic restorations. The Elos Accurate® Customized Abutment will beattached to a dental implant using the included Elos Prosthetic screw. The ElosAccurate® Customized Abutments are compatible with the implant systemslisted in table 1:Elos Accurate CustomizedAbutment – Model Type
	Elos Accurate CustomizedAbutment – Model Type Platformcompatibility Platformdiameter[mm] ImplantBodydiameter[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 BoneLevel 3.3 3.3 AB-SBO41 Straumann BoneLevel 4.1 & 4.8 4.1 & 4.8 All digitally designed CAD/CAM customizations for the Elos Accurate®Customized Abutments are only intended to be sent and manufactured at a FDAregistered Elos Medtech approved milling facility.
Reference PredicateDeviceK173466Panthera DentalMilled Bars	The Panthera Dental Milled Bar is indicated for use as an accessory to anendosseous dental implant to support a prosthetic device in a partially oredentulous patient for purpose of restoring chewing function. It is intendedfor use to support multiple tooth prostheses in the mandible or maxilla. Theprostheses can be screw retained. The Panthera Dental Milled Bars are indicatedfor compatibility with the Zimmer Tapered Screw-Vent System for sizes 3.5 and4.5.

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Predicate and Reference Device Comparisons

Neoss Individual Abutments

Characteristic	Neo ImplantSystem	NeossTitaniumVariousAbutments	Neoss AccessAbutment	Neoss Implant3.25 PrepableAbutments	Neoss TiBaseand CoCrAbutment	Elos	Neoss IndividualProstheticsSubject device	Substantiallyequivalent
510(k)	K043195	K071838	K081851	K090452	K150669	K192457	To be determined	-
Types ofabutments	Abutments forsingle tooth orcementedbridge	Abutmentsfor singletooth orcementedbridge	Multi-unitabutments(incorporatedinto bridges)Bar Abutments(welded orsoldered to barconstructions)	Abutments forsingle tooth orcementedbridge	Abutmentsfor singletooth orcementedbridge	Abutmentsfor singletooth orcementedbridge	Abutments for singletooth or cementedbridge	Yes
Characteristics	Customizableto desiredshape	Customizableto desiredshape	Multi-unitabutment withset ofcustomizableand cast-ablebridge and barabutments	Customizableto desired shape	Customizableto desiredshape	Customizableto desiredshape	Customizable todesired shape	Yes
Characteristic	Neo ImplantSystem	NeossTitaniumVariousAbutments	Neoss AccessAbutment	Neoss Implant3.25 PrepableAbutments	Neoss TiBaseand CoCrAbutment	Elos	Neoss IndividualProstheticsSubject device	Substantiallyequivalent
510(k)	K043195	K071838	K081851	K090452	K150669	K192457	To be determined
Material	Abutments:Titaniumgrade 4.ASTM F67Titaniumalloy, ASTMF136Screws:Titaniumalloy, ASTMF136Gold alloy	Abutments:Titaniumgrade 4,ASTM F67Titaniumalloy, ASTMF136Screws:Titaniumalloy, ASTMF136Gold alloy	Abutments:Titanium alloy,ASTM F136Bridge/BarPostsScrews:Titanium alloy,ASTM F136	Abutments:Titanium grade4, ASTM F67Titanium alloy,ASTM F136Screws:Titanium alloy,ASTM F136	Abutments:Titaniumalloy, ASTMF136CoCr alloy,ASTM F1537Screws:Titaniumalloy, ASTMF136	ElosAccurate®CustomizedAbutments:TitaniumAlloy 6Al-4VELI, medicalgrade 5ElosProstheticscrews:TitaniumAlloy 6Al-4VELI, medicalgrade 5	Abutment:Titanium grade 4.ASTM F67Titanium alloy,ASTM F136Screws:Titanium alloy,ASTM F136	Yes.The materials usedhave been used in theprimary predicatedevice
Surface finish	Abutments:Non-coatedScrews: Non-coated	Abutments:Non-coatedScrews: Non-coated	Abutments:Non-coatedScrews:TiN/Au coated	Abutments:Non-coatedScrews: Non-coated	Abutments:Non-coatedScrews:TiN/Aucoated	Abutment:Non-coatedScrews: Non-coatedMedicarb(DLC)	Abutment/Bar/Bridge:Non-coatedScrews: TiN/Aucoated	Abutments/Bar/Bridge:Yes.Screw:Yes. The coating is thesame as wasintroduced withK081851 and furtherestablished withK150669.
Platformdiameter	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);3.5 mm (NP)	Yes. SP is the same asthe primary predicate,and NP is the same asK090452
Minimum postheight	4 mm	4 mm	Not defined	4 mm	4 mm	4 mm	4 mm	Yes
Characteristic	Neo ImplantSystem	NeossTitaniumVariousAbutments	Neoss AccessAbutment	Neoss Implant3.25 PrepableAbutments	Neoss TiBaseand CoCrAbutment	Elos	Neoss IndividualProstheticsSubject device	Substantiallyequivalent
510(k)	K043195	K071838	K081851	K090452	K150669	K192457	To be determined	-
Gingivalheight	Not defined	Not defined	Not defined	Not defined	0-4mm	0.5-5mm	0.5-4mm	Yes. Within theminimum (0mm) andmaximum (5mm) ofthe predicate devices.
Minimumthickness(adjacent toscrew seating)	Not defined	0.5 mm	Not defined	0.5 mm	0.4 mm	0.4 mm	0.5 mm	Yes
AbutmentAngulation	0 - 20°	0, °15° and20°	0-30°	0, °15° and 20°	0 - 20°	0-30°	0 - 30°	Yes
Abutmentconnection	Internalconnectionwith press-fitofinterlockingmeans	Internalconnectionwith press-fitofinterlockingmeans	Internalconnection withand withoutinterlockingmeans	Internalconnection withpress-fit ofinterlockingmeans	Internalconnectionwith press-fitofinterlockingmeans	Indexed	Internal connectionwith press-fit ofinterlocking means	Yes
Abutmentscrew size	M2 Screw(SP)	M2 Screw(SP)	M2 Screw (SP)	M1.6 screw(NP)	M2 screw(SP)	Not defined	SP: M2 screwNP: M1.6 screw	Yes
Screw Channel	Straight	Straight	0-30°	Straight	Straight	Straight	0 – 25°	Equivalent withK081851 AccessAbutment.
Sterility	Non-sterile	Non-sterile	Sterile andNon-sterile	Non-sterile	Non-sterile	Non-sterile	Non-sterile	Yes
Digital CADSystems	Not specified	Not specified	Not specified	Not specified	Sirona system	510(k)cleared CADsoftware	510(k) cleared CADsoftware	Yes
Characteristic	Neo ImplantSystem	NeossTitaniumVariousAbutments	Neoss AccessAbutment	Neoss Implant3.25 PrepableAbutments	Neoss TiBaseand CoCrAbutment	Elos	Neoss IndividualProstheticsSubject device	Substantiallyequivalent
510(k)	K043195	K071838	K081851	K090452	K150669	K192457	To be determined
Production	Turned andMilled	Turned andMilled	Turned andMilled	Turned andMilled	Turned andMilled	Turned andMilled	Turned and Milled	Yes

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Neoss Individual Bridges and Bars

Bridges and BarsCharacteristic	Neo ImplantSystem	Neoss AccessAbutment	Neoss Implant3.25 PrepableAbutments	Neoss TiBase	Panthera	Neoss IndividualProstheticsSubject device	Substantially equivalent
510(k)	K043195	K081851	K090452	K150669	K173466	To be determined	-
Types ofprosthetics	Multi-unitabutments(incorporatedinto bridges)Bar Abutments(welded orsoldered to barconstructions)	Multi-unitabutments(incorporatedinto bridges)Bar Abutments(welded orsoldered to barconstructions)	Multi-unitabutments(incorporatedinto bridges)Bar Abutments(welded orsoldered to barconstructions)	Multi-unitabutments(incorporatedinto bridges)	One-piece bar,with integratedabutment interfaces(cylinders)	One-piece bridge withintegrated abutmentinterfaces (posts)One-piece bar, withintegrated abutmentinterfaces (cylinders)	Yes
Characteristics	Customizableto desiredshape	Multi-unitabutment withset ofcustomizableand cast-ablebridge and barabutments	Customizable todesired shape	Customizableto desiredshape	Individuallydesigned for eachpatient by order ofprescription.	Customizable to desiredshape	Yes
Bridges and BarsCharacteristic	Neo ImplantSystem	Neoss AccessAbutment	Neoss Implant3.25 PrepableAbutments	Neoss TiBase	Panthera	Neoss IndividualProstheticsSubject device	Substantially equivalent
510(k)	K043195	K081851	K090452	K150669	K173466	To be determined
Material	Abutments:Titanium alloy,ASTM F136Screws:Titanium alloy,ASTM F136Gold alloy	Abutments:Titanium alloy,ASTM F136Bridge/BarPostsScrews:Titanium alloy,ASTM F136	Abutments:Titanium alloy,ASTM F136Screws:Titanium alloy,ASTM F136	Abutments:Titanium alloy,ASTM F136Screws:Titanium alloy,ASTM F136	Titanium alloy	Bar/Bridge:Titanium alloy, ASTMF136Screws:Titanium alloy, ASTMF136	Yes.The materials used havebeen used in the primarypredicate device
Surface finish	Abutments:Non-coatedScrews:Non-coated	Abutments:Non-coatedScrews:TiN/Au coated	Abutments:Non-coatedScrews:Non-coated	Abutments:Non-coatedScrews:TiN/Au coated	Not defined	Bar/Bridge:Non-coatedScrews:TiN/Au coated	Abutments/Bar/Bridge:Yes.Screw: The coating is thesame as was introducedwith K081851 andfurther established withK150669.
Platform/Cylinderdiameter	4.0 mm (SP)	4.0 mm (SP)	3.5 mm (NP)	4.0 mm (SP)	3 – 8 mm	4 mm (SP);3.5 mm (NP)	Yes, SP is the same asthe primary predicate,and NP is the same asK090452
Minimumpost/cylinderheight	4 mm	Not defined	4 mm	4 mm	0 mm	5 mm	Yes
Minimumthickness(adjacent to screwseating)	Not defined	Not defined	0.5 mm	0.4 mm	Not defined	1.0 mm	Yes
Bridges and BarsCharacteristic	Neo ImplantSystem	Neoss AccessAbutment	Neoss Implant3.25 PrepableAbutments	Neoss TiBase	Panthera	Neoss IndividualProstheticsSubject device	Substantially equivalent
510(k)	K043195	K081851	K090452	K150669	K173466	To be determined	-
Bridge/Barconnection	Internalconnection withno interlockingmeans	Internalconnection withno interlockingmeans	Internalconnection withno interlockingmeans	Internalconnectionwith nointerlockingmeans	Not defined	Internal connection withno interlocking means	Yes
Abutment screwsize	M2 Screw (SP)	M2 Screw (SP)	M1.6 screw (NP)	M2 screw (SP)	Not defined	SP: M2 screwNP: M1.6 screw	Yes
Screw Channel	Straight	0-30°	Straight	Straight	Not defined	0 - 25°	Equivalent with K081851Access Abutment.
Minimum crosssections betweenposts/cylinders	Not defined	Not defined	Not defined	Not defined	Height 2.5mmWidth 1.5mm	Height 3 mmWidth 2 mm	Yes. Subject device issubstantially equivalentto predicate devices.
Span betweencylinders	Not defined	Not defined	Not defined	Not defined	0-30 mm	0-30 mm	Yes. Subject device issubstantially equivalentto predicate devices.
Minimum crosssections ofcantilever	Not defined	Not defined	Not defined	Not defined	Height 2.5mmWidth 1.5mm	Height 5 mmWidth 3 mm	Yes. Subject device issubstantially equivalentto predicate devices.
Maximumcantilever length	Not defined	Not defined	Not defined	Not defined	30 mm	Full arch: 15 mmPartial: 6 mm	Yes. Subject device issubstantially equivalentto predicate devices.
Sterility	Non-sterile	Sterile andNon-sterile	Non-sterile	Non-sterile	Non-sterile	Non-sterile	Yes
Production	Turned andMilled	Turned andMilled	Turned andMilled	Turned andMilled	Milled	Milled	Yes

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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.

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.)