FLEXISCOPE OPTOMODUL

K984641 · Schoelly Fiberoptic GmbH · EIA · Mar 29, 1999 · Dental

Device Facts

• Record ID: K984641
• Device Name: FLEXISCOPE OPTOMODUL
• Applicant: Schoelly Fiberoptic GmbH
• Product Code: EIA · Dental
• Decision Date: Mar 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The Flexiscope Optomodul is indicated for use during dental in the country bear when a video image is desired. The Flexiscope Optomodul Is Indreason 2007 - 100 mm a video image is desired.

Device Story

Flexiscope Optomodul is an endoscopic imaging device used in dental procedures. It captures visual data of the oral cavity and transmits it as a video image for clinician viewing. The device assists dentists in visualizing areas of interest during examinations or treatments. It is operated by dental professionals in a clinical setting. The output allows for real-time observation, aiding in clinical decision-making and patient assessment.

Technological Characteristics

Endoscopic imaging system designed for dental applications. Provides video output for visualization. Technical specifications and materials are not detailed in the provided documentation.

Indications for Use

Indicated for use in dental procedures where a video image is required.

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 20850

MAR 2 9 1999

Schoelly Fiberoptic, GmbH C/O Mr. Joseph Ress Medical Device Regulatory Consultants 45 Pontiac Road Newton, Massachusetts 02468

K984641 Re : Flexiscope Optomodul Trade Name: Regulatory Class: I EIA Product Code: December 29, 1998 Dated: Received: December 31, 1998

Dear Mr. Ress

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 The general controls provisions of the Act 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. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements 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

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Page 2 - Mr. Ress

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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" (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 (800) 638-2M41 or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timot 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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Appendix K - Indications for Use

STATEMENT FOR INDICATIONS FOR USE

510 (K) Number:

Device Name: Flexiscope Optomodul

Indications for Use:

The Flexiscope Optomodul is indicated for use during dental
in the country bear when a video image is desired. The Flexiscope Optomodul Is Indreason 2007 - 100 mm a video image is desired.

(PLEASE DO MOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Susan Runne
(Division Sign-Off)

OR

(Controllon of Dental, Infection Control, and General Hosp 510(k) Number