ATLANTIS ABUTMENT FOR NOBEL REPLACE INTERFACE

K053654 · Atlantis Components, Inc. · NHA · Jul 31, 2006 · Dental

Device Facts

• Record ID: K053654
• Device Name: ATLANTIS ABUTMENT FOR NOBEL REPLACE INTERFACE
• Applicant: Atlantis Components, Inc.
• Product Code: NHA · Dental
• Decision Date: Jul 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The Atlantis Abutment is intended for use as an accessory to 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: Nobel Biocare Replace Select Straight, Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage. 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.

Device Story

Atlantis Abutment for Nobel Replace Interface; titanium (Ti-6Al-4V ELI) dental abutment; used as accessory to endosseous dental implants to support cement-retained prosthetic restorations. Device placed over implant shoulder; secured via abutment screw. Compatible with Nobel Replace Select Straight/Tapered implant systems. Used by dental professionals in clinical settings. Provides structural support for prosthetic teeth; enables restoration of function/aesthetics in edentulous patients. Highly angled abutments restricted to anterior region for implants <4mm diameter.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Titanium grade Ti-6Al-4V ELI (ASTM F-136). Form factor: Dental abutment with screw. Compatibility: Nobel Replace Select Straight/Tapered implant systems (3.5mm, 4.3mm, 5.0mm, 6.0mm diameters).

Indications for Use

Indicated for partially or completely edentulous patients requiring single or multiple tooth prosthetic support in the mandible or maxilla. Contraindicated for highly angled (30 degree) abutments on implants <4 mm diameter in the posterior region 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

• Atlantis Abutment and Abutment Screw (K981858)
• Atlantis Abutment and Abutment Screw (K023113)
• Replace TiUnite (K020646)
• Replace Ha Coated Implant

Submission Summary (Full Text)

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K053654

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

# JUL 3 1 2006

## 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.

#### Applicant's Name and Address 。
华尔斯

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

#### 2 Name of Device

| Trade Name: | Atlantis TM Abutment for Nobel Replace Interface |
|----------------------|------------------------------------------------------------------------|
| Common Name: | Endosseous dental implant abutment |
| Classification Name: | Endosseous dental implant abutment<br>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 and Abutment<br>Screw | K981858<br>K023113 |
| Nobel Biocare | Replace TiUnite | K020646 |
| Nobel Biocare | Replace Ha Coated Implant | |

#### ત્વે . 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 ******************************************************************************************************************************************************************************

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

The Atlantis™ Abutments for Nobel Replace Interface and abutment screws are made from Titanium grade Ti-6A1-4V ELI (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 Nobel Replace® Select Straight, Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage for the 3.5 mm (NP), 4.3 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) Implants.

#### Intended Use of the Device ur,

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 as an accessory to 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 coment 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 not intended for the posterior region due to limited strength of the implant.

#### Basis for Substantial Equivalence 6.

The Atlantism Abutments for Nobel Replace Interface are substantially equivalent in intended use, material, design and performance to the Atlantis Abutments cleared under K981858 and Nobel Biocare Replace Tillnite Implants and Replace HA Coated Implants cleared under 510(k) K023113 and K020646 respectively.

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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, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 1 2006

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

Re: K053654

Trade/Device Name: Atlantis™ Abutment for Nobel Replace Interface Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 13, 2006 Received: July 17, 2006

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 vour 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 on user not of the Act or any Federal statutes and regulations administered by other Federal regencies. 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 rogettice 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 desice 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/edrh/industry/support/index.html.

Sincerely vours.

C

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) Kos 365 365 4

Device Name: Atlantis TM Abutment for Nobel Replace Interface

Indication for Use:

The Atlantis Abutment is intended for use as an accessory to 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 maxillated 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: Nobel Biocare Replace Select Straight, Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage.

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)

Fronk Seitz, DDS for D. Duncan Kenner
(yn. OH)