CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS

K033213 · Codent Technical Industry Co., Ltd. · EFB · Feb 6, 2004 · Dental

Device Facts

• Record ID: K033213
• Device Name: CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS
• Applicant: Codent Technical Industry Co., Ltd.
• Product Code: EFB · Dental
• Decision Date: Feb 6, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

CODENT Dental Air-Powered Handpiece, model HPS is intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth. CAUTION: Federal (US) law restricts the use of this device to licensed professionals.

Device Story

Air-powered dental handpiece; utilizes compressed air to drive internal turbine/motor; used by licensed dental professionals in clinical settings for restorative procedures including cavity preparation, tooth structure reduction, and polishing. Device functions as mechanical tool for dental surgery and maintenance; provides high-speed rotation for burs or polishing attachments. Benefits patient by enabling precise removal of decayed tissue and restoration of tooth structure.

Clinical Evidence

Bench testing only.

Technological Characteristics

Air-powered dental handpiece; high-speed turbine/motor assembly; intended for use with standard dental burs and polishing attachments. Class I medical device.

Indications for Use

Indicated for licensed dental professionals performing removal of carious material, reduction of hard tooth structure, cavity preparation, finishing of tooth preparations and restorations, and tooth polishing.

Regulatory Classification

Identification

A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

Predicate Devices

• MICRO MOTORS RSH High Speed Handpiece (K935676)

Submission Summary (Full Text)

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# 5. 510(K) SUMMARY

FEB - 6 2004

K033213

## CONDENT Dental Air-Powered Handpiece Models: HPS

510K: CODENT Technical Industry Co., Ltd. Submitted by: 6F-8, No.7, Wu-Chuan 1st Road, Wu-Ku Industrial Park, Hsin Chuang City, Taipei, 242, Taiwan Dr. Jen. Ke-Min Contact person: No.58, Fu-Chiun Street, Hsin-Chu City,Taiwan, ROC fax: [phone] Tel: [phone] E-mail: ceirs [e-mail] September 27, 2003 Date Summary Prepared: Name of the Device: Dental Air-Powered Handpiece Dental Air-Powered Handpiece ( class I medical Classification: device; 21 CFR 872.4200 ) Procuct code: EFB Panel: 72 MICRO MOTORS RSH High Speed Handpiece Predicate Device: 510K. No -- K935676 The CODENT Dental Air- Powered Handpiece is Statement of Intended Use: intended for removing escious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth. CAUTION: Federal (US) haw restricts the use of this device to licensed professionals.

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The claim of substantial equivalence is based on Performance Data: comparisons of formulations and intended uses of the HPS Dental Air-Powered Handpiece and its claimed predicate.

:

Conclusion:

Based on the information in the notification CODENT believes that Dental Air-Powered Handpiece HPS is substantially equivalent to the claimed predicate, i.e., MICRO MOTORS RSil High Speed Handpiece (k935676)

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized eagle emblem. The eagle is depicted with three wavy lines representing its body and wings, symbolizing the department's mission to protect and enhance the health and well-being of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB = 6 2004

Codent Technical Industry Company Limited C/O Dr. Jen, Ke-Min Ph.D. Official Correspondent Dr. Jen Ke-Min No.58, Fu- Chiun Street, Hsin- Chu City, TAIWAN, ROC

Re: K033213

Trade/Device Name: CODENT Dental Air- powdered Handpiece, Model HPS Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: December 18, 2003 Received: December 30, 2003

Dear Dr. Ke-Min:

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, thereforc, 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 adultcration.

If your device is classified (sec 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, I'DA may publish further announcements concerning your device in the Ecderal Register.

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Page 2 –Dr. . Ke-Min

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 mean that I DT mas made a statutes and regulations administered by other Federal agencies. of the Act of ally i ederal states and registments, including, but not limited to: registration 1 our must comply with art 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CF R Part 807), lateling (QS) regulation (21 CFR Part 820); and if requirements as so form in the quadiation 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) IThis letter will anon your copa finding of substantial equivalence of your device to a premarket nothrounom. - 11 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), If you desire specific at no Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other gencral 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/dsma/dsmamain.html

Sincerely yours,

Quls

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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### Indications for Use

| 510(k) Number (if known): | K033213 |
|---------------------------|---------|
|---------------------------|---------|

# Device Name: CODENT Dental Air-Powered Handpiece, model HPS

#### Indications for Use:

- CODENT Dental Air-Powered Handpiece, model HPS is intended for removing carious � CODENT Delucing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
- CODENT Dental Air-Powered Handpiece carries the following label: . CAUTION: Federal (US)) law restricts the use of this device to licensed professionals.

AND/OR Prescription Use x (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ruan

on of Anesthesin Infection Controi Dent

510(k) Number: K033213

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