ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW

K981858 · Atlantis Components, Inc. · DZE · Mar 22, 1999 · Dental

Device Facts

• Record ID: K981858
• Device Name: ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW
• Applicant: Atlantis Components, Inc.
• Product Code: DZE · Dental
• Decision Date: Mar 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Indications 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 prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The impression coping is intended to transfer the position of the implant in the oral cavity to a working cast. The impression coping screw is intended to temporarily secure the impression coping to either the implant fixture or the analog fixture.

Device Story

Atlantis Abutment System serves as interface between endosseous dental implants and prosthetic restorations. Dentist prescribes abutment; Atlantis designs and manufactures custom abutment based on prescription. Abutment attaches to implant via Atlantis screw; supports screw-retained or cement-retained prostheses. Impression copings facilitate transfer of implant position to working casts. System used in dental clinics by dentists to restore oral function in edentulous patients.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological and design identity to predicate devices.

Technological Characteristics

Endosseous implant abutment system. Components include abutment, abutment screw, and impression coping. Designed for interface with endosseous implants in mandible or maxilla. Materials and design are identical to predicate Lifecore Biomedical UCLA abutment system.

Indications for Use

Indicated for partially or completely edentulous patients requiring single or multiple tooth prostheses supported by endosseous implants in the mandible or maxilla.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

• Lifecore Biomedical RD Hexed UCLA Abutment Gold Sleeve (K931468, K944069)
• Lifecore Biomedical RD Titanium UCLA Abutment Screw (K931468, K944069)

Submission Summary (Full Text)

{0}------------------------------------------------

3/22/99

KA81858

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| Submitted by: | Atlantis Components, Inc.<br>270 Third Street<br>Cambridge, MA 02142-1112<br>617-661-9799<br>fax [phone]<br>[e-mail] |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Andrew Ziegler, Chief Technology Officer |
| Device Name: | Atlantis Abutment System |
| Classification Name: | Class III Endosseous Implants per 21 C.F.R. 872.3640 |
| Equivalent Device: | Lifecore Biomedical RD Hexed UCLA Abutment Gold Sleeve<br>and Lifecore Biomedical RD Titanium UCLA Abutment Screw<br>With .048 in Hex. (These are covered in one or more of the<br>following: K931468, K944069.) |
| Device Description: | The Atlantis abutment is an abutment used with an endosseous<br>implant that is implanted in the upper or lower jawbone. The<br>abutment sits on the implant interface and is retained by the<br>Atlantis screw. The abutment allows the option for the prostheses<br>to be cemented directly to the abutment, or to be retained by a<br>screw. The abutment is ordered by prescription from a Dentist,<br>then is designed and manufactured by Atlantis to that prescription. |
| Intended Use: | The Atlantis abutment is intended for use as an accessory to an<br>endosseous implant to support a prosthetic device in a partially or<br>completely edentulous patient. It is intended for use to support<br>single and multiple tooth prostheses, in the mandible or maxilla.<br>The prostheses can be screw or cement retained to the abutment.<br>The abutment screw is intended to secure the abutment to the<br>endosseous implant. The impression coping is intended to<br>transfer the position of the implant in the oral cavity to a working<br>cast. The impression coping screw is intended to temporarily<br>secure the impression coping to either the implant fixture or the<br>analog fixture. |
| Comparison of Technological Characteristics: | The technological characteristics of the<br>Atlantis Abutment System and the corresponding predicate |

Lifecore UCLA abutment are identical.

Atlantis Components, Inc. CONFIDENTIAL 5/22/98

б

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines, creating a sense of unity and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 2 1999

Mr. Andrew Ziegler Chief Technology Officer Atlantis Components, Incorporated 270 Third Street Cambridge, Massachusetts 02142-1112

Re : K981858 Trade Name: Atlantis Abutment and Atlantis Abutment Screw Regulatory Class: III Product Code: DZE Dated: December 21, 1998 Received: December 22, 1998

Dear Mr. Ziegler

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

{2}------------------------------------------------

Page 2 - Mr. Ziegler

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Patrucci Cucerite/for

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

LABELING AND INSTRUCTIONS:

## ATLANTIS ABUTMENT SYSTEM DEVICE NAME:

## INDICATIONS FOR USE

The Atlantis Abutment is used to connect an implanted fixture to a restoration.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Susa Rurr
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devic 510(k) Number .

Atlantis Components, Inc. CONFIDENTIAL 5/22/98

11