ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT IN ZIRCONIA, ATLANTIS GEMEINI + ABUTMENT IN ZIRCONIA

K052070 · Atlantis Components, Inc. · NHA · Oct 14, 2005 · Dental

Device Facts

• Record ID: K052070
• Device Name: ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT IN ZIRCONIA, ATLANTIS GEMEINI + ABUTMENT IN ZIRCONIA
• Applicant: Atlantis Components, Inc.
• Product Code: NHA · Dental
• Decision Date: Oct 14, 2005
• 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.

Device Story

Atlantis Abutment in Zirconia serves as dental implant accessory; supports cement-retained prosthetic restorations in partially or completely edentulous patients. Device consists of yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) abutment and titanium alloy (Ti-6Al-4V ELI) screw. Used by dental professionals to secure prosthetic devices to endosseous implants in mandible or maxilla. Provides structural support for single or multiple tooth replacements. Operates as mechanical interface between implant and prosthesis.

Clinical Evidence

Bench testing only.

Technological Characteristics

Abutment material: Yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) per ISO 6872 & 13356. Abutment screw material: Titanium grade Ti-6Al-4V ELI per ASTM F-136. Mechanical interface: Compatible with external hex implant systems (flat-to-flat dimensions ≥ 2.7mm).

Indications for Use

Indicated for partially or completely edentulous patients requiring single or multiple tooth prosthetic support in the mandible or maxilla. Compatible with endosseous implant systems featuring an external hex with flat-to-flat dimensions of 2.7mm or greater. May be used in early load situations depending on specific implant system and protocol.

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

• Procera Abutment Branemark, Models 10-4001, 10-40 (K042658)

Submission Summary (Full Text)

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K052070

OCT 1 4 2005

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: 617-661-9799 Fax Number: 617-661-9063 Contact Person: Franklin Uyleman Manager of Quality and Regulatory Affairs

#### 2. Name of Device

| Trade Name: | Atlantis™ Abutment in Zirconia |
|----------------------|------------------------------------------------------------------------|
| 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) Number |
|---------------|------------------------------------------------------|---------------|
| Nobel Biocare | Procera Abutment Branemark, Models<br>10-4001, 10-40 | K042658 |

#### 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 -----------------------

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

The Atlantis™ Abutment in Zirconia is made of the biocompatible material, yttriastabilized tetragonal zirconia polycrystals (Y-TZP) (Meets ISO standards 6872 & 13356) and the abutment screw is made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136).

#### Intended Use of the Device న్.

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 cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

#### Basis for Substantial Equivalence 6.

The Atlantis™ Abutment in Zirconia is substantially equivalent in intended use, material, design and performance to the Nobel Biocare Procera Abutment Branemark cleared under K042658.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K052070

Trade/Device Name: Atlantis™ Abutment in Zirconia Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abument Regulatory Class: II Product Code: NHA Dated: July 29, 2005 Received: August 1, 2005

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.

OCT 1 4 2005

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### Page 2 - Ms. Brown

Please be advised that FDA's issuance of a substantial equivalence determination does not Fleast be advised that I Da determination that your device complies with other requirements nicall that 1 Dr may Federal statutes and regulations administered by other Federal agencies. of the Act of ally I outral black s requirements, including, but not limited to: registration 1 ou intilest comply was a 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 es read on the quality systems (QS) regulation (21 CFR Part 820); and if requirements as betrenic 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) This letter will anow you to began 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), rt you decire type at 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,

Sutie y. Michael Davis.

Chiú 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) 1052070

Device Name: Atlantis IM Abutment in Zirconia

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 support a prosinent device in a particity of costhesis, in the mandible or maxilla. The for use to support single and manapie the abutment. The abutment screw is intended to prosure the abutment to the endosseous implant.

This device is compatible with the following manufacturers' implant systems having an external hex with flat-to-flat dimensions of 2.7mm or greater: Nobel Biocare, 3i, Lifecore, Sterngold ImplaMed, Innova, and BioHorizons.

Steringold inforded, may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Prescription Use
(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)

Suser Keare

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

510(k) Number: