INTRAORAL LENS OPTION TO SPECTROSHADE

K012744 · Mht Optic Research AG · EIA · Jan 23, 2002 · Dental

Device Facts

• Record ID: K012744
• Device Name: INTRAORAL LENS OPTION TO SPECTROSHADE
• Applicant: Mht Optic Research AG
• Product Code: EIA · Dental
• Decision Date: Jan 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

SpectroShade's intraoral lens option is an accessory imaging device, which is intended for use by dental professionals in taking intraoral images of dental anatomy in order to: 1) Assist in the assessment of the overall patient's dental health by providing magnified digital images of the oral cavity. 2) Provide visual educational information to the patient to more effectively communicate a treatment plan. 3) Provide documented images for patient records, insurance companies, and other dental professionals. 4) Allow the practitioner to display before and after images of dental procedures.

Device Story

Intraoral lens accessory for SpectroShade system; captures magnified digital images of dental anatomy. Used by dental professionals in clinical settings. Provides visual documentation for patient records, insurance, and treatment planning; facilitates patient education via before/after procedure displays. Device functions as an imaging aid to assist practitioners in assessing dental health.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Accessory intraoral lens for digital imaging. Operates as a component of the SpectroShade system. No specific materials, energy sources, or software algorithms detailed in the provided documentation.

Indications for Use

Indicated for dental professionals to capture magnified digital images of dental anatomy for health assessment, patient education, documentation, and procedure visualization.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 3 2002

Mr. Markus Angst MHT Optic Research AG Mandachstr. 50 Niederhasli, SWITZERLAND

Re: K012744

Trade/Device Name: Intraoral Lens Option To SpectroShade Regulation Number: 872.6640 Regulation Name: Dental Operative Unit Accessory Regulatory Class: I Product Code: EIA Dated: November 5, 2001 Received: November 7, 2001

Dear Mr. Angst:

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.

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.

{1}------------------------------------------------

Page 2 - Mr. Angst

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 (OS) 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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/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

{2}------------------------------------------------

510(k) Number: K012744

Intraoral Lens Option to SpectroShade Device Name:

## Indications for Use:

SpectroShade's intraoral lens option is an accessory imaging device, which is intended for use by dental professionals in taking intraoral images of dental anatomy in order to:

- 1) Assist in the assessment of the overall patient's dental health by providing magnified digital images of the oral cavity.
- 2) Provide visual educational information to the patient to more effectively communicate a treatment plan.
- 3) Provide documented images for patient records, insurance companies, and other dental professionals.
- 4) Allow the practitioner to display before and after images of dental procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ruscoe

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices KO12744 510(k) Number -

Prescription Use V (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Appendix A- 3