ACE HA SCREW DENTAL IMPLANT SYSTEM

K021244 · Ace Surgical Supply Co., Inc. · DZE · May 3, 2002 · Dental

Device Facts

• Record ID: K021244
• Device Name: ACE HA SCREW DENTAL IMPLANT SYSTEM
• Applicant: Ace Surgical Supply Co., Inc.
• Product Code: DZE · Dental
• Decision Date: May 3, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ace HA Screw Dental Implant System is intended to be used in totally edentulous mandibles or maxillae or as a terminal or intermediary abutment for fixed or removable bridgework. The system can also be used for single tooth restorations.

Device Story

The Ace HA Screw Dental Implant System is an endosseous dental implant used for tooth replacement. It is surgically placed into the mandible or maxilla by a dental professional to serve as an anchor for fixed or removable bridgework or single tooth restorations. The device functions as a prosthetic foundation to restore oral function and aesthetics for edentulous patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endosseous dental implant system. Materials and specific technical dimensions are not detailed in the provided text.

Indications for Use

Indicated for patients with totally edentulous mandibles or maxillae, or patients requiring terminal or intermediary abutments for fixed or removable bridgework, or single tooth restorations.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. J. Edward Carchidi ACE Surgical Supply Company Limited 1034 Pearl Street Brockton, Massachusetts 02301

Re: K021244

Trade/Device Name: Ace HA Screw Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: April 15, 2002 Received: April 19, 2002

## Dear Dr. Carchidi:

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 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.

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.

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## Page 2 - Dr. Carchidi

You must comply with all the Act's requirements, including, but not limited to: registration r ou must config17 with and 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 OF RT Far 807), Modity systems (QS) regulation (21 CFR Part 820); and if requirence as betwents 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 1110 letter vill and in your of your of substantial equivalence of your device to 310(t) promiser nounce 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the and additionally 21 Cl [phone]. Additionally, for questions on the promotion and Office of Comphance wice, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours

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

Enclosure

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Ace Surgical Supply Co., Inc ..

Special 510(k) Notification: HA Screw Dental Implant System

# Attachment 4 - Indications for Use Enclosure

510(k) Number: _ KO21244

Device Name: Ace HA Screw Dental Implant System

### Intended Use / Indications for Use:

The Ace HA Screw Dental Implant System is intended to be used in totally edentulous mandibles or maxillae or as a terminal or intermediary abutment for fixed or removable bridgework. The system can also be used for single tooth restorations.

### (PLEASE DO NOT WRITE BELOW THIS LINE/CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Punr

(Division Sign-Off) (Division of Dental, Infection Control, and General Hospital C 510(k) Number -

Prescription Use (per 21 CFR 801.109)

OR

Over the Counter Use _ Optional Format 1-2-96