DENTALVIEW PERIOVIEW SYSTEM

K973492 · Dentalview, Inc. · EIA · Oct 21, 1997 · Dental

Device Facts

• Record ID: K973492
• Device Name: DENTALVIEW PERIOVIEW SYSTEM
• Applicant: Dentalview, Inc.
• Product Code: EIA · Dental
• Decision Date: Oct 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The PerioView system by DentalView is a system intended for use in direct visualization and therapy of periodontal disease and other situations that would require visualization of structures beneath an intact gumline within the oral cavity.

Device Story

PerioView system enables direct visualization of subgingival structures; used for periodontal disease diagnosis and therapy. Device provides visual access beneath intact gumline in oral cavity. Operated by dental professionals in clinical settings. Output consists of direct visual information to assist clinician in assessing periodontal health and performing therapeutic interventions. Benefits include improved diagnostic and therapeutic accuracy for subgingival conditions.

Indications for Use

Indicated for patients requiring direct visualization and therapy of periodontal disease or other conditions necessitating visualization of structures beneath an intact gumline within the oral cavity.

Regulatory Classification

Identification

A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. Wendell Ebling President/CEO Dentalview, Incorporated 15540-D Rockfield Boulevard Irvine, California 92618

OCT 21 1997

Re: K973492 Dentalview Perioview System Trade Name: Requlatory Class: I Product Code: EIA September 12, 1997 Dated: Received: September 15, 1997

Dear Mr. Ebling:

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 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 against 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. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (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 through 542 of the Act for devices under the Electronic

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Page 2 - Mr. Ebling

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 requlation (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" (21 CFR 807.97). Other general 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/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

. Enclosure

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K973.492

## INDICATIONS FOR USE STATEMENT

The PerioView system by DentalView is a system intended for use in direct visualization and therapy of periodontal disease and other situations that would require visualization of structures beneath an intact gumline within the oral cavity.

Angela Blockwell for Susan Sumner

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