MRS-400, MAXI 400, MRSL-400, MAXI 400L

K981990 · D.B.I. America Corp. · EFB · Jun 22, 1998 · Dental

Device Facts

• Record ID: K981990
• Device Name: MRS-400, MAXI 400, MRSL-400, MAXI 400L
• Applicant: D.B.I. America Corp.
• Product Code: EFB · Dental
• Decision Date: Jun 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The dental handpiece is intended to be used by dentists to prepare dental cavities for restorations such as fillings and for cleaning teeth.

Device Story

Dental handpiece and accessories used by dentists for cavity preparation and tooth cleaning. Device functions as a mechanical tool for dental procedures. Operated by dental professionals in a clinical setting. Output is the physical removal of tooth structure or cleaning of tooth surfaces. Benefits include facilitating restorative dental procedures and oral hygiene maintenance.

Clinical Evidence

No clinical data provided; device is a standard dental handpiece.

Technological Characteristics

Dental handpiece (21 CFR 872.4200). Mechanical device for dental procedures. No software or electronic components described.

Indications for Use

Indicated for use by dentists to prepare dental cavities for restorations (e.g., fillings) and for cleaning teeth.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 2 1998

D.B.I America Corporation ·C/O Mr. Kent Donohue Staff Engineer Engineering Services Underwriters Laboratories, Incorporated® 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, North Carolina 27709-3995

Re : K981990 MRS-400, MAXI-400, MRSL-400, MAXI-400L Trade Name: Regulatory Class: I Product Code: EFB Dated: June 5, 1998 June 8, 1998 Received:

Dear Mr. Donohue:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Donohue

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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

Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K981G90 510(k) Number (if known):_

Device Name:_ Dental Handpiece and Accessories (21 CFR 872.4200)

Indications For Use:

The dental handpiece is intended to be used by dentists to prepare dental cavities for restorations such as fillings and for cleaning teeth.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Pinar

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number 10981990

Prescription Use (Per 21CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)