BETA-POWDER

K063236 · Brainbase Corporation · KOJ · Feb 16, 2007 · Dental

Device Facts

• Record ID: K063236
• Device Name: BETA-POWDER
• Applicant: Brainbase Corporation
• Product Code: KOJ · Dental
• Decision Date: Feb 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6080
• Device Class: Class 2

Indications for Use

Cleaning, polishing and restoring natural esthetics of tooth enamel.

Device Story

B-Powder is a dental polishing/prophy powder composed primarily of beta-tricalcium phosphate with trace hydroxyapatite. Used by dental professionals in a clinical setting, the powder is intended for use with an air-polishing device (air brush) to clean and polish tooth enamel. The device functions by mechanical abrasion to remove surface stains and restore natural tooth esthetics. Safety is established through chemical analysis confirming low levels of heavy metal contaminants (Cd, Pb, Hg, As).

Clinical Evidence

Bench testing only. Chemical characterization performed using X-ray diffraction to confirm crystalline structure and inductively coupled plasma/mass spectroscopy and atomic absorption spectrophotometry to quantify heavy metal contaminants (Cd, Pb, Hg, As), all found to be below 0.5 ppm.

Technological Characteristics

Fine powder composed of beta-tricalcium phosphate and hydroxyapatite. Relatively inert and biocompatible. Analyzed via X-ray diffraction, inductively coupled plasma/mass spectroscopy, and atomic absorption spectrophotometry. No performance standards applicable; follows Class II Special Controls Guidance for Dental Bone Grafting Material Devices where applicable.

Indications for Use

Indicated for cleaning, polishing, and restoring the natural esthetics of tooth enamel in patients requiring dental prophylaxis.

Regulatory Classification

Identification

An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.

Special Controls

The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”

Predicate Devices

• Clinpro Prophy Powder (K021450)
• New Prophy Powder (K014188)

Submission Summary (Full Text)

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K063236

### 510(k) Summary

FEB ! 6 2007

Submitter: Satoshi Noake, International Division, BrainBase Corporation, Tokyo, Japan, Phone: [phone], Fax: + 81-3-3778-4910.

- I. Classification Name and Number: Air Brush (accessory),
- II. Product name(s):

XIV.

- II.1 . Common or Usual Name: prophy powder, polishing powder
- II.2. Proprietary Name: B-Powder
- III. Registration No: 3005488486
- Compliance with Performance Standards: No performance standards are applicable. IV. However we followed "Class II Special Controls Guidance: Document: Dental Bone Grafting Material Devices", issued April 28, 2005 where applicable because of the materials content.
- V. Description of the Device: The ß-Powder system is comprised primarily of ßtricalcium phosphate. X-ray diffraction methods were used to identify the crystalline structure. These studies showed that the main constitutent of the device is ßtricalcium phosphate with a small amount of hydroxyapatite, but no other contaminants. Inductively coupled plasma/mass spectroscopy was used for cadmium (Cd) and lead (Pb) analyses, and atomic absorption spectrophotometry was used for mercury (Hg) and arsenic (As). The levels of these harmful elements were below 0.5 ppm
- Labels and Labeling: Draft labels of ß-powder, instructions for use, warnings and VI. contraindications are provided.
- Substantial Equivalence: ß Powder is intended for use as a polishing or prophy VII. powder. This use is the same as that for Clinpro Prophy Powder, cleared in K021450 by 3M Espe Dental Products, and New Prophy Powder, cleared in K014188 by Dentsply, Intl. The materials are the same or similar to those that have been used in commercially marketed products before.

The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below:

1. These products have the same intended use as predicate devices, for cleaning, polishing, and restoring the natural esthetics of teeth.

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2. The technological characteristics for this product are similar to those of the predicate devices and those currently on the market They are fine powders, relatively inert, biocompatible and previously used for periodontal purposes.

3. Descriptive information provided shows that the materials from which this device is made are well-established and well understood in the industry and among professional users.

4. The FDA "Decision-Making Process" chart was used and appears in Appendix V.

(End of Summary)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem featuring a stylized eagle with its wings spread, clutching a caduceus in its talons. The emblem is black and white.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Satoshi Noake Brainbase Corporation Yoneyama 2nd Building 6F, 22-13, Oi 1-chome Shinagawa-ku, Tokyo Japan 140-0014

FEB 16 2007

Re: K063236 Trade/Device Name: B-Powder Regulation Number: 872.6080 Regulation Name: Airbrush Regulatory Class: II Product Code: KOJ Dated: February 5, 2007 Received: February 9, 2007

Dear Mr. Noake:

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. Noake

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/industry/support/index.html.

Sincerely yours.

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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## XII. Indications for Use

510(k) Number: (not assigned)

Device Name: β - Powder

Indications for Use:

Cleaning, polishing and restoring natural esthetics of tooth enamel.

Prescription Use (Per 21 CFR 801 Subpart D)

or

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 Rung

Are (200 Off) ivisua of Anesthestology, General Hospital, non Control, Dental Devices

Repl. p. 6

K562236