X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE

K042466 · Zest Anchors, Inc. · NHA · Nov 24, 2004 · Dental

Device Facts

• Record ID: K042466
• Device Name: X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE
• Applicant: Zest Anchors, Inc.
• Product Code: NHA · Dental
• Decision Date: Nov 24, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The X-2 Implant Attachment is designed for use with overdentures or partial dentures, retained in whole or in part by endosseous implants in the mandible or maxilla. The X-2 Bar Attachment System is designed for use with overdentures or partial dentures retained in whole or in part by bar splinted endosseous implants in the mandible or maxilla. The X-2 Distal Extension Attachment System is designed for use with partial dentures retained in whole or in part by bar splinted endosseous implants and crowned roots with a distal extension in the mandible or maxilla.

Device Story

X-2 Implant, Bar, and Distal Extension Attachment Systems are dental prosthetic components; used to retain overdentures or partial dentures; interface with endosseous implants or bar-splinted implants in mandible or maxilla; provide mechanical retention for removable dental prostheses; operated by dental professionals; facilitate patient oral function and prosthetic stability.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endosseous dental implant abutment system; mechanical attachment components for overdentures/partial dentures; intended for use with dental implants; class II device.

Indications for Use

Indicated for patients requiring overdentures or partial dentures retained by endosseous implants or bar-splinted implants in the mandible or maxilla.

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.)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes emanating from its head, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 2004

Mr. Paul Zuest President Zest Anchors, Incorporated 2061 Wineridge Place, #100 Escondido, California 92029

Re: K042466

Trade/Device Name: X-2 Implant Bar and Distal Extension Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 3, 2004 Received: November 5, 2004

Dear Mr. Zuest:

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 vour 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.

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

Page 2 - Mr. Zuest

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact 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/dsma/dsmamain.html

Sincerely vours.

Carl G

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

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

## Indications for Use

510(k) Number:

Device Name:

Indications for Use:

Image /page/2/Picture/5 description: The image shows a graphic with a dark gray header that says "Multi-Part Device". Below the header is a white box that says "X-2 Implant, Bar and Distal Extension". The text is centered in the box.

## INDICATIONS

The X-2 Implant Attachment is designed for use with overdentures or partial dentures, retained in whole or in part by endosseous implants in the mandible or maxilla.

## INDICATIONS

The X-2 Bar Attachment System is designed for use with overdentures or partial dentures retained in whole or in part by bar splinted endosseous implants in the mandible or maxilla.

## INDICATIONS

The X-2 Distal Extension Attachment System is designed for use with partial dentures retained in whole or in part by bar splinted endosseous implants and crowned roots with a distal extension in the mandible or maxilla.

Prescription Use X (Part 21 CFR 801 Subpart D)

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 Runner

Division of Anesthesiology, General Hospital Infection Control, Dental Device 510(k) Number

Page 1 of 1

Koyaylab