APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2

K033198 · Apoza Enterprise Co., Ltd. · ELC · Apr 30, 2004 · Dental

Device Facts

• Record ID: K033198
• Device Name: APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2
• Applicant: Apoza Enterprise Co., Ltd.
• Product Code: ELC · Dental
• Decision Date: Apr 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Apoza Selector U2 is designed for the dentists to remove the calculus or stains on surface of teeth or clean the root canal ( with endo-kit) in the prophylaxis procedures. CAUTION: Federal (US) law restricts the use of this device to licensed professionals.

Device Story

Ultrasonic scaler unit for dental prophylaxis; removes calculus/stains from teeth; cleans root canals using specialized endo-kit. Operated by dentists in clinical settings. Device transforms electrical energy into ultrasonic vibrations delivered via handpiece/tips. Provides mechanical cleaning action. Benefits include efficient removal of dental deposits and root canal debris.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Ultrasonic scaler; electrical energy source; handpiece with interchangeable tips for scaling and endodontic procedures. Class II device. No specific materials or software algorithms described.

Indications for Use

Indicated for dental prophylaxis procedures, specifically the removal of calculus or stains from tooth surfaces and root canal cleaning (when used with an endo-kit) by licensed dental professionals.

Regulatory Classification

Identification

An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

Predicate Devices

• SATELEC SUPRASSON P5 BOOSTER (K961158)

Submission Summary (Full Text)

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### 5. 510(K) SUMMARY

# APR 3 0 2004

## APOZA ULTRASONIC SCALER AND ENDODONTIC'S UNIT Models: SELECTOR U2

510K:

| Submitted by: | APOZA ENTERPRISE CO, LTD. |
|-----------------|--------------------------------------------------|
| | 6F, No.657, Chuang Chong Road, Hsin-Chuang City, |
| | Taipei Hsien, China (Taiwan) |
| Contact person: | General Manager |
| | Mr. SHIH MIN-TEH |

September 27, 2003 Date Summary Prepared:

Classification name: Scaler, Ultrasonic ●

ELC', Class H ● Classification number:

Regulation Number: 872.4850

.

.

.

SCALER AND ULTRASONIC Proprietary name: APOZA ENDODONTICS UNIT, SELECTOR 02

Common name of device: Ultrasonic Scaler .

SATELEC SUPRASSON P5 BOOSTER Predicate Device:

510K No K961158

Tre Apoza Selector U2 is designed for the deatists to Statement of Intended Use: remove the calculus or stains on surface of teeth or clean the root canal ( with endo-kit) in the prophylaxis procedures. - The device carries the following label:

CAUTION: Federal (US) law restricts the use of this device to licensed professionals.

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## Comparison to Predicate Devices: The APOZA Ultrasonic Scaler, Sciector U2, has

been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addinon, performance testing has been done to validate the performance of the device. The comparison and validation results presented in this 510k notification to the FDA show that the subject device is substantially equivalent to predicated device and is safe and effective in its intended use. We believe that the APOZA Ultrasonic Scaler, Selector U2 is substantially equivalent to the predicate device, i.e., SATELEC SUPRASSON P5 BOOSTER(K961158), and the data provided support the safety and effectiveness of Selector 'J2 for the intended uses.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes across its body, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is in black and white.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 3 0 2004

Mr. Shih Min-Teh Official Correspondent Apoza Enterprise Company, Limited 6 F, No. 657, Chuang-Cheng Road, Hsin-Chuang City, Taipei Hsicn, CHINA (Taiwan) 242

Re: K033198

Trade/Devicc Name: Apoza Ultrasonic Scaler and Endodontics Unit, Selector U2 Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: February 9, 2004 Received: February 17, 2004

Dear Mr. Min-Tch:

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.

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Page 2 - Mr. Min-Teh

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.

ClsLs

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 STATEMENT 4.

Applicant : ___________________________________________________ 510(k) Number : TO BE ASSIGNED APOZA ULTRASONIC SCALER AND Device Name . . ENDODONTICS UNIT, SELECTOR U2

### Indications for Use :

The Apoza Selector U2 is designed for the dentists to remove the calculus or stains on surface of teeth er clean the root canal ( with endo-kit) in the prophylaxis procedures.

The device carries the following label:

CAUTION: Federal (US) law restricts the use of this device to licensed professionals.

ULTEAN! DO MOLEVRITOW THIS LINE-CONTINUE ON ANSITUAR LAGE IN NEFARTO Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use Per 21 CFR 801 109

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Over-The-Counter

(Optional Formal 1-2-96)

Robert S. Betz for Dr. Susan Renner

510(k) Number: K033198