SMARTBURS

K080687 · S.S. White Burs, Inc. · EJL · Jun 20, 2008 · Dental

Device Facts

• Record ID: K080687
• Device Name: SMARTBURS
• Applicant: S.S. White Burs, Inc.
• Product Code: EJL · Dental
• Decision Date: Jun 20, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3240
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

After primary access using another instrument, Smartburs is intended to selectively remove decayed dentin, without removal of healthy dentin from tooth surfaces. Smartburs is not designed to cut or remove enamel, composite, amalgam, cementum, or healthy dentin.

Device Story

Smartburs are dental burs used by dentists to selectively remove decayed dentin. Device requires primary access to the tooth to be established by another instrument before use. Operates by mechanical abrasion; design specifically targets decayed tissue while sparing healthy dentin, enamel, composite, amalgam, and cementum. Used in clinical dental settings to facilitate caries removal; aids clinicians in preserving healthy tooth structure during restorative procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental bur; mechanical cutting/abrasion instrument. Designed for selective dentin removal. Class I device under 21 CFR 872.3240.

Indications for Use

Indicated for selective removal of decayed dentin in patients requiring dental caries treatment, following primary access by another instrument. Contraindicated for cutting or removing enamel, composite, amalgam, cementum, or healthy dentin.

Regulatory Classification

Identification

A dental bur is a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone. It is also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 0 2008

Mr. Derek Gladden Management Representative S.S. White Burs, Incorporated 1145 Towbin Avenue Lakewood, New Jersey 08701

Re: K080687

Trade/Device Name: Smartburs Regulation Number: 21 CFR 872.3240 Regulation Name: Dental Bur Regulatory Class: I Product Code: EJL Dated: May 23, 2008 Received: June 9, 2008

Dear Mr. Gladden:

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. Gladden

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.

Suite Y. Michie Omd.

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): K080687

Device Name: Smartburs

Indications for Use:

After primary access using another instrument, Smartburs is intended to selectively remove decayed dentin, without removal of healthy dentin from tooth surfaces. Smartburs is not designed to cut or remove enamel, composite, amalgam, cementum, or healthy dentin.

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

Over-The-Counter Use (21 CFR Part 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 Plummer

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K080652

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