ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES

K043325 · Rolence Enteprise, Inc. · EIA · Feb 11, 2005 · Dental

Device Facts

• Record ID: K043325
• Device Name: ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES
• Applicant: Rolence Enteprise, Inc.
• Product Code: EIA · Dental
• Decision Date: Feb 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The ZoomCam LD-10 Intraoral Camera and Accessories are indicated for use to provide a image of the mouth before and after the dental procedure, which assists the dentist in describing the dental procedure being performed as well as the results.

Device Story

ZoomCam LD-10 is an intraoral camera system used in dental clinics. Device captures visual images of oral cavity; transmits data to display monitor for dentist and patient viewing. Primary function is visual documentation and patient education regarding dental procedures. Operated by dental professionals. Output is real-time or captured still imagery. Benefits include improved patient understanding of clinical findings and treatment outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intraoral camera system; optical imaging sensor; handheld form factor; connects to external display/monitor. Class I device (21 CFR 872.6250).

Indications for Use

Indicated for use by dentists to capture and display intraoral images before and after dental procedures to assist in patient communication and documentation.

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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Public Health Service

FEB 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Sterling Cheng Manager Rolence Enterprise, Incorporated 18-3, Lane 231 Pu Chung Road Chungli 320, TAIWAN R.O.C

Re: K043325

Trade/Device Name: ZoomCam LD-10 Regulation Number: 872.6250 Regulation Name: Dental Chair and Accessories Regulatory Class: I Product Code: EIA Dated: November 11, 2004 Received: December 2, 2004

Dear Mr. Cheng:

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 apps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 (1 Nr.), it an 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 - Cheng

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. or met 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) ring reter 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,

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): K043325

Device Name: ZoomCam LD-10

Indications for Use:

The ZoomCam LD-10 Intraoral Camera and Accessories are indicated for use to provide a image of the mouth before and after the dental procedure, which assists the dentist in describing the dental procedure being performed as well as the results.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rupp

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Sion Sion-Off Ision of Anesthesiology, General Hospital. Intection Control, Dental Devices

Number: Kou3326