ATLANTIS ABUTMENT FOR STRAUMANN INTERFACE

K050052 · Atlantis Components, Inc. · NHA · Mar 7, 2005 · Dental

Device Facts

• Record ID: K050052
• Device Name: ATLANTIS ABUTMENT FOR STRAUMANN INTERFACE
• Applicant: Atlantis Components, Inc.
• Product Code: NHA · Dental
• Decision Date: Mar 7, 2005
• 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 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 for Straumann Interface; titanium (Ti-6Al-4V ELI) component; functions as accessory to endosseous dental implants. Device placed over implant shoulder; secured via abutment screw. Supports cement-retained prosthetic restorations. Used in dental clinical settings by dental professionals. Provides structural support for prosthetic teeth in edentulous patients; restores masticatory function.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Titanium grade Ti-6Al-4V ELI (ASTM F-136). Form factor: Dental abutment for Straumann Standard/Standard Plus/Tapered Effect Regular Neck implants. Mechanical fixation via screw. Non-software device.

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.

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)

Submission Summary (Full Text)

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Pre-market Notification Page - 000009 MAR 7 - 2005

K050052

### SECTION 10 - 510 (K) SUMMARY VII.

This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR Part 807.92.

#### Applicants Name and Address .

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

#### 2. Name of Device

Atlantis ™ Abutment for Straumann Interface Trade Name: Endosseous dental implant abutment Common Name: 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) Number |
|--------------------------|-----------------------------------------|---------------|
| Atlantis Components Inc. | Atlantis Abutment and<br>Abutment Screw | K981858 |

4. 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 Notification Page -= = = = = = = = = = = = = = = = =

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

The Atlantis™ Abutments for Straumann 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 Straumann Standard Regular Neck (RN) implants with 3.3, 4.1, and 4.8mm diameters; Standard Plus Regular Neck (RN) with 3.3, 4.1, and 4.8mm diameters and the Tapered Effect Regular Neck (RN) with the 3.3 and 4.1mm diameters.

#### Intended Use of the Device ಳು

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 રું.

The Atlantis™ Abutments for Straumann Interface are substantially equivalent in intended use, material, design and performance to the Atlantis Abutments cleared under K981858.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure. The symbol is composed of three curved lines that converge to form the shape of a bird's head and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 7 - 2005

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

Re: K050052

K050052
Trade/Device Name: Atlantis™ Abutment for Straumann Interface Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: NHA Dated: January 6, 2005 Received: January 10, 2005

Dear Ms. Brown:

We have reviewed your Section 510(k) premarket notification of intent to market the device the We have reviewed your Scenon 210(tr) promation is substantially equivalent (for the referenced above and have determined the active in analy in the Medical Devices marketed in
indications for use stated in the enclosure) to legally markets of the Medical Dev indications for tise stated in the cherosared to to regulared date of the Medical Device with the provision interstate commerce prior to way 20, 1770, the childed in accordance with the provisions of Amendments, or to devices that have been recurse approval of approval of a prematked the Federal Food, Drug, and Cosmetic Act (71ct) that she ice, subject to the general
approval application (PMA). You may, therefore, market the Aet include approval application (1 MA). 1 od may, macontrols provisions of the Act include controls provisions of the Act. "The genting of devices, good manufacturing practice, requirements for annual regionst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III II your device is classified (see above) into controls. Fxisting major regulations affecting (PMA), it may be subject to such additional controls: Title 21, Tarts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title 21, the Federal your device can be found in the Code of Pederal Regioner of 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 I least that FDA has made a determination that your device complies with other requirements Incall that I DA nas made a determand regulations administered by other Federal agencies. UI the Act of ally i oderal baker and equirements, including, but not limited to: registration 1 ou must comply with and 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 007), labelity systems (QS) regulation (21 CFR Part 820); and if requirements as sectionic 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) I mis letter will and in you be organization of substantial equivalence of your device to a promatics notification. - The Presults 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), r you desire specific advise 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 may obtain 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,

Ching-Lin, Ph.D.

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 -000205

## Indications for Use

1050052 510(k) Number (if Known)

Device Name: Atlantis ™ Abutment for Straumann 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 maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous 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)

Anesthesiology, General Hospil. on Control, Dental Devices

Number: 1050052

693000