ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT

K073540 · Atlantis Components, Inc. · NHA · Feb 29, 2008 · Dental

Device Facts

• Record ID: K073540
• Device Name: ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT
• Applicant: Atlantis Components, Inc.
• Product Code: NHA · Dental
• Decision Date: Feb 29, 2008
• 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.

Device Story

Atlantis Abutment in Zirconia is a dental prosthetic component; provides support for cement-retained restorations on endosseous implants. Device consists of yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) abutment and titanium alloy screw. Placed by dental professionals in clinical settings; secured to implant shoulder via screw. Enables prosthetic reconstruction in partially or completely edentulous patients. Benefits include customized support for single/multiple tooth prostheses. Device compatibility includes specific BioHorizons implant systems. Clinical use allows for early loading depending on specific implant protocol.

Clinical Evidence

No clinical data. Substantial equivalence based on material composition, design, and mechanical performance testing consistent with predicate devices.

Technological Characteristics

Materials: Yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) per ISO 6972 & 13356; abutment screws: Ti-6Al-4V ELI per ASTM F-136. Form factor: Custom abutment for endosseous dental implants. Connectivity: None (mechanical device). Sterilization: Not specified.

Indications for Use

Indicated for partially or completely edentulous patients requiring single or multiple tooth prosthetic support in the mandible or maxilla. Compatible with BioHorizons Prodigy and Maestro implant systems. Contraindications: Highly angled abutments (30 degrees) on implants <4mm diameter are not for posterior use due to limited implant 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

• AtlantisTM Abutment in Zirconia for Zimmer Implant (K053450)
• The Prodigy SystemTM Dental Implants (K042429)

Submission Summary (Full Text)

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# FEB 2 9 2008

Pre-market Notification Page - 000009 - - - - - - - - - - - - - - - - - -

### 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 Telephone Number: 617-871-2783 Fax Number: 617-871-6607 Contact Person: Franklin Uyleman Manager of Quality and Regulatory Affairs

#### 2. Name of Device

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

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

| Manufacturer | Device | 510(k)<br>Number |
|-------------------------------------|-------------------------------------------------------|------------------|
| Atlantis Components<br>Inc. | AtlantisTM Abutment in Zirconia for<br>Zimmer Implant | K053450 |
| BioHorizons Implant<br>Systems Inc. | The Prodigy SystemTM Dental<br>Implants | K042429 |

#### 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 - 000010 - -------------------

#### 4. Description of the Device (continued)

The Atlantis™ Abutments in Zirconia for BioHorizons Implant and abutment screws are made from biocompatible vttria-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 BioHorizons Prodigy System™ 3.5mm, 4.0mm, 5.0mm and 6.0mm Implants and BioHorizons The Maestro™ System Implants RBM and HA coated 3.5mm, 4.0mm and 5.0mm Implants.

#### 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 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.

#### 6. Basis for Substantial Equivalence

The Atlantis™ Abutments in Zirconia for BioHorizons Implants are substantially equivalent in intended use, material, design and performance to the Atlantis Abutments for Zimmer Interface cleared under K053373 and BioHorizons Prodigy System™ Dental Implants cleared under K042429.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of several curved lines.

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 2 9 2008

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

Re: K073540

Trade/Device Name: Atlantis™ Abutment in Zirconia for BioHorizons Implant Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 11, 2007 Received: December 18, 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 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 vour 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,

Snytte y. Michian Omd.

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) K07 3540

Device Name: Atlantis ™ Abutment in Zirconia for BioHorizons Implant

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: BioHorizons The Prodigy System™ Dental Implants 3.5mm, 4.0mm, 5.0mm and 6.0mm Implants and BioHorizons The Maestro™ System Implants RBM and HA coated 3.5mm, 4.0mm and 5.0mm Implants.

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.

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 X (Part 21 CFR 801 SubpartD) AND/OR

Over-The-Counter Use (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)

Susa
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k073546