Predicate Devices

Reference Devices

K071838, K081851, K090452, K150669, K192457, K173466

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a CAD/CAM process for designing and manufacturing dental prosthetics based on clinician/technician input and verification, with no mention of AI or ML algorithms for design, analysis, or manufacturing optimization.

Therapeutic

No.
The device is used as an aid in prosthetic rehabilitation by connecting to dental implants to support restorations, not for treating a disease or condition itself.

Diagnostic

No

The device is described as an aid in prosthetic rehabilitation, specifically dental implant abutments, bridges, or bars, designed to support restorations. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly states that the device is a physical dental prosthetic (abutments, bridges, and bars) manufactured from titanium. While digital design is involved, the final product is a physical medical device.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Description: The description clearly states that Neoss Individual Prosthetics are dental implant abutments, bridges, and bars. These are physical devices intended to be implanted or attached within the mouth to support dental restorations.
Intended Use: The intended use is "as an aid in prosthetic rehabilitation," which involves restoring missing teeth with artificial prosthetics. This is a mechanical and structural function, not a diagnostic one based on analyzing biological specimens.
Lack of IVD Characteristics: The text does not mention any analysis of biological samples, diagnostic purposes, or any of the typical components or processes associated with IVD devices (reagents, assays, specimen collection, etc.).

Therefore, the Neoss Individual Prosthetics are classified as dental prosthetic devices, not In Vitro Diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

NHA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K043195

Reference Device(s)

K071838, K081851, K090452, K150669, K192457, K173466

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.)

Summary

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 (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

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ 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: 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)

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
(K043195, K083561,
K113376) | Neoss Implants NP
(K090452) | Neoss Access
Abutments
(K081851) |
|-------------------------------|-----------------------------------------------------|--------------------------------|----------------------------------------|
| Neoss Individual
Abutments | Compatible | Compatible | Not compatible |
| Neoss Individual
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
Number |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| ISO 10993-1 Fifth edition 2018-08, Biological evaluation of medical devices - Part
1: Evaluation and testing within a risk management process | 2-258 |
| ISO 14801 Third edition 2016-11-01, Dentistry-Implants-Dynamic fatigue test for
endosseous dental implants. | 4-259 |
| ISO 14801 Second edition 2007-11-15, Dentistry - Implants-Dynamic fatigue test
for 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 sterilization
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
Neoss Individual
Prosthetics	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.
Primary Predicate
Device
K043195 Neo
Implant System	The Neo Abutments includes a set of components that are intended to function
on Neo implants or compatible external hex, Replace Select implants and
Straumann implants, as a base prosthetic construction.
Reference Predicate
Device	The Neoss Titanium Preparable Abutment 15°and 20° and Neoss Express
abutments are designed to be connected to the Neoss implant and are

Indications for Use

7

| K071838 Neoss
Various Titanium

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

8

Predicate and Reference Device Comparisons

Neoss Individual Abutments

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

9

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11

Neoss Individual Bridges and Bars

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