ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONE

K083871 · Astra Tech, Inc. · NHA · Apr 15, 2009 · Dental

Device Facts

• Record ID: K083871
• Device Name: ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONE
• Applicant: Astra Tech, Inc.
• Product Code: NHA · Dental
• Decision Date: Apr 15, 2009
• 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™ Straumann Bone Level Abutment is a dental implant abutment used to support prosthetic restorations. The device consists of an abutment and a titanium screw, placed into an endosseous dental implant to provide a base for cement-retained single or multiple tooth prostheses. Used in dental clinics by dental professionals. The abutment is secured to the implant shoulder via the screw. Benefits include providing structural support for prosthetic reconstruction in edentulous patients. The device is available in titanium (Ti-6Al-4V ELI) or yttria-stabilized tetragonal zirconia polycrystals (Y-TZP).

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Titanium grade Ti-6Al-4V ELI (ASTM F-136) and yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) (ISO 6072 & 13356). Form factor: Dental abutment for endosseous implants. Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for partially or completely edentulous patients requiring single or multiple tooth prosthetic support in the mandible or maxilla via cement-retained restorations. Compatible with specific Straumann 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

• SLactive Implants (K053088)
• P.0004 Implants (K062129)
• Straumann Narrow Neck (K060958)
• AtlantisTM Abutment for Straumann Interface (K050052)
• AtlantisTM Abutment in Zirconia (K052070)

Submission Summary (Full Text)

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K083871

Pre-market Notification Page - 000009

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# APR 1 5 2009

# 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

Astra Tech 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™ Straumann Bone Level Abutment Common Name: Endosseous dental implant abutment Classification Name: Endosseous dental implant abutment 21 CFR 872.3630 Product code NHA

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

| Manufacturer | Device | 510(k)<br>Number |
|------------------------------------------------------------|------------------------------------------------|------------------|
| Institut Straumann AG | SLactive Implants | K053088 |
| Institut Straumann AG | P.0004 Implants | K062129 |
| Institut Straumann AG | Straumann Narrow Neck | K060958 |
| Atlantis Components<br>Inc. (currently Astra<br>Tech Inc.) | AtlantisTM Abutment for Straumann<br>Interface | K050052 |
| Atlantis Components<br>Inc. (currently Astra<br>Tech Inc.) | AtlantisTM Abutment in Zirconia | K052070 |

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KOE3871

Pre-market Page - 000010 - - - - - - - - - - - - - - -

# 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. The Atlantis™ Straumann Bone Level Abutment and abutment screw are made from Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.3mm, 4.1mm and 4.8mm sizes. In addition, the Atlantis™ Straumann Bone Level Abutment for the 4.1mm and 4.8mm sizes, also are made of the biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) (meets ISO Standards 6072 & 13356). The titanium and the zirconium abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.

The titianium abutments are compatible with Struamann Implants: Standard SLActive 3.3mm, 4.1mm and 4.8mm; and the Straumann Narrow Neck 3.5mm.

The abutments in zirconia are compatible with Straumann Implants: SLActive 4.1mm and 4.8mm

## 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™ Straumann Bone Level Abutments in titanium are substantially equivalent in intended use, material, design and performance to the Straumann SLActive abutments cleared under K053088, K062129, and K060958, as well as the Atlantis Abutments for Straumann Interface cleared under K050052. Also, the Atlantis™ Straumann Bone Level Abutments in zirconium are substantially equivalent in intended use, material, design and performance to the Atlantis™ Abutments in Zirconium cleared under K052070.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white, giving it a formal and official appearance.

Public Health Service

APR 1 5 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Astra Tech Incorporated C/o Ms. Betsy A. Brown B.A. Brown & Associates 8944 Tamaroa Terrace Skokie, Illinois 60076

Re: K083871

Trade/Device Name: Atlantis™ Straumann Bone Level Abutment Regulation Number: 21 CFR 872.3630 Regulatory Class: II Product Code: NHA Dated: April 10, 2009 Received: April 13, 2009

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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Page 2- Ms. Brown

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Susan Renner

Susan Runner, D.D.S., MA Acting 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

KO83871 510(k) Number (if Known)

Device Name: Atlantis TM Straumann Bone Level Abutment

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:

The titanium abutments are compatible with the Straumann Implants: Standard SLActive 3.3mm, 4.1mm and 4.8mm and the Straumann Narrow Neck 3.5mm

The abutments in zirconia are compatible with the Straumann Implants: SLActive 4.1mm and 4.8mm.

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 (Part 21 CFR 801 SubpartD)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

*Signature* Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|----------------------------------------------|----------|
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K96-3571 |