ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS

K071946 · Atlantis Components, Inc. · NHA · Oct 5, 2007 · Dental

Device Facts

• Record ID: K071946
• Device Name: ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS
• Applicant: Atlantis Components, Inc.
• Product Code: NHA · Dental
• Decision Date: Oct 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Atlantis Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. This device is compatible with the following manufacturers' implant systems: Astra Tech Systems OsseoSpeed™ Implants 3.5 mm, 4.0mm, 4.5 mm and 5.0 mm diameters. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Also, highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

Device Story

Atlantis Abutment in Zirconia serves as interface between endosseous dental implant and prosthetic restoration; supports cement-retained single or multiple tooth prostheses. Device consists of yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) abutment and titanium (Ti-6Al-4V ELI) screw. Placed by dental professionals in clinical settings; mounted over implant shoulder and secured via screw. Provides structural support for prosthetic reconstruction in mandible or maxilla. Highly angled abutments restricted to anterior region for smaller diameter implants. Benefits patient by restoring dental function and aesthetics in edentulous cases.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and material compliance with ISO 6972 and 13356 for zirconia and ASTM F-136 for titanium screws.

Technological Characteristics

Materials: Yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) per ISO 6972/13356; Titanium alloy (Ti-6Al-4V ELI) screw per ASTM F-136. Form factor: Endosseous dental implant abutment. Compatibility: Astra Tech OsseoSpeed implants (3.5, 4.0, 4.5, 5.0 mm diameters). Mechanical fixation via screw.

Indications for Use

Indicated for partially or completely edentulous patients requiring single or multiple tooth prosthetic support in the mandible or maxilla. Compatible with Astra Tech OsseoSpeed implants (3.5-5.0 mm diameters). Contraindicated for highly angled (30°) abutments on <4 mm diameter implants in the posterior region due to limited fixture strength.

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

• Atlantis Abutment for Astra Implant (K070833)
• Fixture MicroThreadTM OsseoSpeedTM (K053384)
• Astra Tech Implants-Dental System Fixture OsseoSpeed (K024111)
• Astra Tech Implants- Dental Systems Fixture MicroMarco (K024111)

Submission Summary (Full Text)

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K071946

Pre-market Notification Page - 00009 - - - - - - - - - - - - - - -

OCT 5 * 2007

# VII. SECTION 10 - 510(K) SUMMARY

This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR Part 807.92.

## 1. Applicant's Name and Address

Atlantis Components Inc. 25 First Street Cambridge, Massachusetts 02141 617-661-9799 Telephone Number: 617-661-9063 Fax Number: Contact Person: Franklin Uyleman Manager of Quality and Regulatory Affairs

# 2. Name of Device

| Trade Name: | Atlantis™ Abutment in Zirconia for Astra Implant |
|----------------------------------|--------------------------------------------------|
| Common Name: | Endosseous dental implant abutment |
| Classification Name: | Endosseous dental implant abutment |
| 21 CFR 872.3630 Product code NHA | |

#### 3. Legally Marketed Device to which Equivalence is claimed (Predicate Device)

| Manufacturer | Device | 510(k)<br>Number |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------|------------------|
| Atlantis Components<br>Inc. | Atlantis Abutment for Astra Implant | K070833 |
| Astra Tech Implant<br>Systems | Fixture MicroThreadTM OsseoSpeedTM | K053384 |
| Astra Tech Implants<br>Systems | Astra Tech Implants-Dental System<br>Fixture OsseoSpeed<br>Astra Tech Implants- Dental Systems<br>Fixture MicroMarco | K024111 |

## 4. Description of the Device

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations.

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Pre-market Page - 00010 - - - - - - - - - - - - - -

## 4. Description of the Device (continued)

The Atlantis™ Abutments in Zirconia for Astra Implants is made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356). The abutment screws are made from titanium grade Ti-6A1-V ELI and meets ASTM Standard F-136. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with the Astra Tech OsseoSpeed™ implants 3.5 mm, 4.0 mm, 4.5 mm and 5.0 mm diameters.

### 5. Intended Use of the Device

The devices covered by this submission are abutments which are placed into a dental implant to provide support for a prosthetic reconstruction. The Atlantis Abutment is intended to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

Please note, highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to the limited strength of the implant fixture.

#### 6. Basis for Substantial Equivalence

The Atlantis™ Abutments in Zirconia for Astra Implant are substantially equivalent in intended use, material, design and performance to the Atlantis Abutments for Astra Implants cleared under K070833 and for Astra Tech Systems implants cleared under K053384 and K024111.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Atlantis Components, Incorporated C/O Ms. Betsy A. Brown Consultant B.A. Brown & Associates 8944 Tamaroa Terrace Skokie, Illinois 60076

OCT 5 ° 2007

Re: K071946

Trade/Device Name: Atlantis™ Abutment in Zirconia for Astra Implants Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 20, 2007 Received: September 24, 2007

Dear Ms. Brown:

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 - Ms. Brown

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device 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 vours.

Signature

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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Pre-market Notification Page - 000227

# Indications for Use

510(k) Number (if Known) KD7 1946

Device Name: Atlantis TM Abutment in Zirconia for Astra Implants

Indication for Use:

The Atlantis Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

This device is compatible with the following manufacturers' implant systems: Astra Tech Systems OsseoSpeed™ Implants 3.5 mm, 4.0mm, 4.5 mm and 5.0 mm diameters.

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Also, highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

| Prescription Use<br>(Part 21 CFR 801 SubpartD) | X | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |
|------------------------------------------------|---|--------|------------------------------------------------|--|
|------------------------------------------------|---|--------|------------------------------------------------|--|

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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

(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

| 510(k) Number: | K071946 |
|----------------|---------|
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