NEOSS VARIOUS TITANIUM ABUTMENTS

K071838 · Neoss, Ltd. · NHA · Oct 19, 2007 · Dental

Device Facts

• Record ID: K071838
• Device Name: NEOSS VARIOUS TITANIUM ABUTMENTS
• Applicant: Neoss, Ltd.
• Product Code: NHA · Dental
• Decision Date: Oct 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Neoss various Titanium Abutments are designed to be connected to the Neoss implants and intended for use as an aid in prosthetic rehabilitation.

Device Story

Neoss Titanium Abutments (15°/20° preparable, Express, and Locator systems) connect to Neoss endosseous dental implants to support prosthetic rehabilitation. Devices are fabricated from commercially pure titanium; supplied non-sterile. Preparable abutments allow for chairside modification; Express abutments facilitate abutment-level impressions; Locator system provides retention for overdentures or partial dentures. Used by dental professionals in clinical settings to secure dental prosthetics to implants via abutment screws. Output is a stable interface between the implant and the dental prosthesis, improving patient oral function and aesthetics.

Clinical Evidence

Bench testing only. The device was tested in accordance with the FDA Class II Special Controls Guidance Document for Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. Results confirmed the abutments meet recommended mechanical requirements.

Technological Characteristics

Materials: Commercially pure titanium. Design: Preparable 15°/20° abutments, Express abutments, and Locator abutment system. Connectivity: Mechanical interface to Neoss dental implants via abutment screw. Sterilization: Supplied non-sterile.

Indications for Use

Indicated for prosthetic rehabilitation in patients requiring overdentures or partial dentures retained by endosseous implants in the mandible or maxilla.

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

• Angulated Abutment (K974738)
• Neoss Abutments (K043195)
• Locator components (K994257)
• Locator components (K012911)

Submission Summary (Full Text)

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Kc71838

# SECTION 2.

## A. 510(k) SUMMARY

### 0C7 1 9 2007

### Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes the Neoss Ltd summary for the Neoss various Titanium Abutments

| SUBMITTER'S NAME: | Neoss Ltd |
|---------------------|------------------------------------------|
| ADDRESS: | Windsor House |
| | Cornwall Road |
| | Harrogate, HG1 2PW, UK |
| CONTACT PERSON: | Fredrik Engman |
| TELEPHONE NUMBER: | [phone] , [phone] |
| FAX NUMBER: | [phone] |
| E-MAIL | [e-mail] |
| DATE OF SUBMISSION: | June 26, 2007 |

#### 1. Identification of device

- Classification name: Proprietary Name: Common Name: Classification Status: Product Codes:
Abutment, Implant, Dental. Endosseous Neoss Various Titanium Abutments including accessories Dental Abutment Class II per regulations 872.3630 NHA

#### 2. Equivalent devices

Neoss various Titanium Abutments consist of preparable 15° and 20° abutments, Express abutments and the Locator Abutment system,

Neoss Ltd believes the Neoss Titanium Prepable Abutment 15°and 20° is substantially equivalent to the Angulated Abutment previously cleared in K974738 and to the abutment connection in the Neoss Abutments previously cleared in K043195.

The Neoss Express Abutment is substantially equivalent to the Neoss Abutments previously cleared in K043195.

The Neoss Locator Abutment system is substantially equivalent to Zest Anchors Inc. Locator components initially cleared in K994257 by Zest Ancors Inc and also in K012911 submitted by Implant Innovations Inc.

The accessories are equal to Neoss previous K043195.

#### 3. Description of the Device

The Neoss Titanium Prepable Abutment 15°and 20° is designed to be modified and secured directly to the implant using an abutment screw and supplied non-sterile.

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The Neoss Express Abutment requires no modification and allows for abutment level impression taking.

The Neoss Locator Abutment system, made by commercially pure titanium, designed to secured directly to the implant using an abutment screw and supplied non-sterile.

#### 4. Intended use

The Neoss Titanium Preparable Abutment 15°and 20° and Neoss Express abutments are designed to be connected to the Neoss implant and are intended for use as an aid in prosthetic rehabilitation.

The Neoss Locator Abutment system is intended for use with over dentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.

#### 5. Technological characteristics, comparison to predicate device.

Substantial equivalence of the Neoss Various Titanium Abutments and accessories is based on design similarities between the predicative device and the devices in this application, since the devices are very similar in terms of material, size, preparation and basic design.

#### 6. Discussion of performance testing.

Mechanical testing requested for Dental Implant Systems are described in the Guidance for industry and FDA staff, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant Abutments, dated May 12, 2004.

The The Neoss Various Titanium Abutment has, where applicable, been tested in accordance to the Guideline (Doc. No. 0043 - Guidance for industri and FDA staff, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant Abutments, dated May 12, 2004) and the test results show that the abutment fills the recommended requirements.

#### 7. Conclusion

.

Based on comparison and performed testing, the The Neoss Various Titanium Abutment and accessories are substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like figure above it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 2007

Mr. Fredrik Engman CTO Neoss Limited Windsor House Cornwall Road Harrogate, HG1 2PW UNITED KINGDOM

Re: K071838

Trade/Device Name: Neoss various Titanium Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 26, 2007 Received: July 24, 2007

Dear Mr. Engman:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Engman

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Eugite G. Michie MD.

Chiu Lin, Ph.D. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### B. INDICATIONS FOR USE

510(k) Number K071838

Device Name: Neoss various Titanium Abutments

Indications for Use:

The Neoss various Titanium Abutments are designed to be connected to the Neoss implants and intended for use as an aid in prosthetic rehabilitation.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE) --

Prescription Use OR (Per 21 CFR 801.109)

Over the Counter Use

Susan Runov

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K071833

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