ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBEL

K091920 · Astra Tech, Inc. · NHA · Sep 28, 2009 · Dental

Device Facts

• Record ID: K091920
• Device Name: ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBEL
• Applicant: Astra Tech, Inc.
• Product Code: NHA · Dental
• Decision Date: Sep 28, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

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 and screw 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 Replace® Straight Groovy 3.5mm, Nobel Replace® Select Tapered and Straight 3.5mm and NobelSpeedy TM 3.5mm 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.

Device Story

Atlantis Abutment in Zirconia; endosseous dental implant abutment; supports prosthetic restorations (cement or screw-retained). Input: patient-specific dental anatomy/implant site. Operation: abutment placed over implant shoulder; secured with titanium alloy screw. Used by dental professionals in clinical settings. Provides structural support for dental prostheses; benefits patients by restoring function/aesthetics in edentulous sites. Highly angled abutments restricted to anterior region due to strength limitations.

Clinical Evidence

No clinical data provided. Substantial equivalence based on bench testing and material compliance with ISO 6872 and ISO 13356 standards.

Technological Characteristics

Materials: Yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) per ISO 6872 & 13356; abutment screws: Ti-6Al-4V ELI per ASTM F-136. Form factor: Custom abutment for Nobel Replace/Speedy 3.5mm implants. 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 via endosseous dental implants. Highly angled abutments (30°) on implants <4mm diameter restricted to anterior region.

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 in Zirconia for Nobel Replace Implant (K062277)
• Replace TiUnite (K023113)
• Atlantis Abutment in Zirconia (K052070)

Submission Summary (Full Text)

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Ko91920

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

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# 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. 590 Lincoln Street Waltham, Massachusetts 02451 Telephone Number: Fax Number: Contact Person:

781-810-6462 781-810-6719 Franklin Uyleman Manager of Quality and Regulatory Affairs

#### 2. Name of Device

Atlantis™ Abutment in Zirconia for Nobel Replace Trade Name: Implant ´ Common Name: Endosseous dental implant abutment Endosseous dental implant abutment Classification Name: 21 CFR 872.3630 Product code NHA

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

| Manufacturer | Device | 510(k)<br>Number |
|-----------------------------------------------------------|-------------------------------------------------------------|------------------|
| Astra Tech Inc.<br>(formerly Atlantis<br>Components Inc.) | Atlantis™ Abutment in Zirconia for<br>Nobel Replace Implant | K062277 |
| Nobel Biocare | Replace TiUnite | K023113 |
| Astra Tech Inc.<br>(formerly Atlantis<br>Components Inc.) | Atlantis Abutment in Zirconia | K052070 |

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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. Zirconia may have a variation in shade. The subject abutments are indicated for cemented restorations. The Atlantis™ Abutments in Zirconia for Nobel Replace Implants and abutment screws are made from biocompatible yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6872 & 13356 and may be produced in any composition complying with the values specified by these standards.. 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 Nobel Replace® Straight Groovy 3.5mm. Nobel Replace® Select Tapered and Straight 3.5mm, and NobelSpeedy™ 3.5mm implants.

#### 5. Intended Use of the Device

The Atlantis Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely endentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement or screw 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 Replace® Straight Groovy 3.5mm, Nobel Replace® Select Tapered and Straight 3.5mm and NobelSpeedy TM 3.5mm 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.

#### Basis for Substantial Equivalence 6.

The Atlantis™ Abutments in Zirconia for Nobel Replace Implants are substantially equivalent in intended use, material, design and performance to the Atlantis Abutments in Zirconia cleared under K052070. Atlantis Abutments in Zirconia for Nobel Replace cleared under K062277 and Nobel Replace cleared under K023113.

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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 depiction of an eagle with three bars above it, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle symbol. The image is in black and white and appears to be a scan or photocopy.

SEP 2 8 2009

Food and Drug Administration 10903 New Hampshire Avenne Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

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

Re: K091920

Trade/Device Name: Atlantis™ Abutment in Zirconia for Nobel Replace Implant Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 15, 2009 Received: June 30, 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

for

Susan Runner, D.D.S., M.A. Acting Division 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) Ko91920

Device Name: Atlantis ™ Abutment in Zirconia for Nobel Replace 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 and screw 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 Replace® Straight Groovy 3.5mm, Nobel Replace® Select Tapered and Straight 3.5mm and NobelSpeedyTM 3.5mm 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)

Kein Haley fa WSR

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

510(k) Number: K091920