← Product Code [EIA](/productcode/EIA) · K984556

# SCICAN CLASSIC (K984556)

_Scholly Fiberoptic GmbH · EIA · Feb 9, 1999 · Dental · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K984556

## Device Facts

- **Applicant:** Scholly Fiberoptic GmbH
- **Product Code:** [EIA](/productcode/EIA.md)
- **Decision Date:** Feb 9, 1999
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.6640
- **Device Class:** Class 1
- **Review Panel:** Dental

## Indications for Use

The purpose of the SciCan Classic and accessories is to provide video images of the mouth and oral structures, dental cavities, dental pulps, dental canal morphology. It is used to perform various diagnostic procedures, to provide educational information to patients as well as to other clinical personnel and to provide documentation for patient records and for insurance companies. SciCan Classic also is used for inspection of reliable diagonsis of border gaps when dealing with inlays. Additionally it acts as an effective caries detector during the examination of areas of the mouth which are normally difficult to approach. Further indications for use are extra-oral imaging of the whole face and of the mouth, outline imaging of the quadrants and macroscopic images of the dental enamel.

## Device Story

SciCan Classic is a video camera system for dental imaging. Input: optical images of oral structures captured via interchangeable handpiece probes. Operation: fiber optic illumination; CCD sensor converts light to video signal (NTSC/PAL); automatic exposure control. Output: real-time video images displayed for clinician. Used in dental clinics by dentists/personnel for diagnostic procedures, patient education, and clinical documentation. Benefits: provides visual access to difficult-to-reach areas, aids in caries detection, and facilitates record-keeping.

## Clinical Evidence

Bench testing only. No clinical data provided.

## Technological Characteristics

Modular video camera system with interchangeable handpiece probes. Features 1/2" CCD sensor, fiber optic illumination, and automatic exposure control. Power consumption 150W. Complies with IEC 601-1, IEC 601-1-2 (DIN EN 60601-1-2), and IEC 601-2-18. NTSC/PAL video output.

## Regulatory 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.

## Predicate Devices

- Welch Allyn Reveal Intraoral Camera System ([K981937](/device/K981937.md))

## Submission Summary (Full Text)

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Ka84556

# 510(k) Summary - Summary of Safety and Effectiveness Information_

| Submitter's Name & Adress: | Schölly Fiberoptic GmbH                           |
|----------------------------|---------------------------------------------------|
|                            | Robert-Bosch-Strasse 1-3                          |
|                            | D-79211 Denzlingen                                |
| Contact Person;            | Carsten Schlenker                                 |
| Telephone &                | Tel.: 00 49 - 76 66 - 9 08 - 2 05                 |
| Fax:                       | Fax: 00 49 - 76 66 - 9 08 - 385                   |
| Date Summary Prepared:     | October 30, 1998                                  |
| Device Name:               | Device trade Name - SciCan Classic                |
|                            | Common Name - Video Camera System and Accessories |
|                            | Classification Name - Unit, Operative Dental      |
| Predicate Device:          | Welch Allyn Reveal Intraoral Camera System        |
|                            | (510(k) number K981937)                           |

### Device Description, Intended Use & Effectiveness:

The purpose of the SciCan Classic and accessories is to provide video images of the mouth and oral structures, dental cavities, dental pulps, dental canal morphology. It is used to perform various diagnostic procedures, to provide educational information to patients as well as to other clinical personnel and to provide documentation for patient records and for insurance companies.

SciCan Classic also is used for inspection of reliable diagonsis of border gaps when dealing with inlays. Additionally it acts as an effective caries detector during the examination of areas of the mouth which are normally difficult to approach. Further indications for use are extra-oral imaging of the whole face and of the mouth, outline imaging of the quadrants and macroscopic images of the dental enamel.

| Comparison feature | SciCan Classic                                                        | Welch Allyn Reveal (K981937)                                                   |
|--------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------------|
| General            |                                                                       |                                                                                |
| design             | modular design due handpiece<br>system with interchangeable<br>optics | modular design due handpiece<br>system with interchangeable<br>optics (lenses) |
| power consumtion   | 150 Watt                                                              | 144 Watt                                                                       |
| Camera Typ         | Video camera system                                                   | Video camera system                                                            |
| Video System       | NTSC / PAL                                                            | PAL                                                                            |
| Camera chip        | CCD ½"                                                                | CCD 1/4"                                                                       |
| Illumination       | fiber optic illumination provided<br>by an integrated light source    | fiber optic illumination provided<br>by an integrated light source             |
| light control      | CCD, automatic exposure control                                       | CCD, automatic exposure control                                                |
| handpiece          | removable and interchangeable<br>probe options                        | removable and interchangeable<br>lens (probe )options                          |
| probes             | 90° probes, 0° probe                                                  | 90° probes, 0° probe                                                           |
| standards met      | IEC 601-1, IEC 601-1-2 (DIN EN<br>60601-1-2),<br>IEC-601-2-18         | IEC 601, EN 60601-1-2, AS3200.1.0                                              |

#### Technological Characteristics:

| drawn up /by:    | 11/29/98/cs | file:       | ANL03FDA.DOC |
|------------------|-------------|-------------|--------------|
| last change /by: | -           | department: | R&D          |
| revision:        | 0           | page        | 12           |

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# Summary of Safety:

The SciCan Classic was designed to provide safety to the patient as well as the user and assisting personnel. The device complies with IEC 601-1-2, and IEC 601-1-2, and IEC 601-2-18.

### Summary of Effectiveness:

The SciCan Classic is effective for its intended use of providing video images for the above described purposes and procedures.

| drawn up /by:    | 11/29/98 / cs | file:       | ANL03FDA.DOC |
|------------------|---------------|-------------|--------------|
| last change /by: | -             | department: | R&D          |
| revision:        | 0             | page        | 13           |

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 9 1999

Mr. Carsten Schlenker Regulatory Affairs Manager Scholly Fiberoptic GmbH Robert-Bosch-Strasse 1-3 D-79211 Denzlingen

Re: K984556 Scican Classic Trade Name: Requlatory Class: I Product Code: EIA Dated: November 29, 1998 December 23, 1998 Received:

Dear Mr. Schlenker:

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 The general controls controls provisions of the Act. 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 requlations 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 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 Reqister. 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. Schlenker

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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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| 510(k) Number (if known): | K984556        |
|---------------------------|----------------|
| Device Name:              | SciCan Classic |

Indications For Use:

The SciCan Classic and accessories are indicated for use when video images are desired to provide visual information during dental examinations and procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runor

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number 16 78 155 65 6 510(k) Number.

Image /page/4/Picture/7 description: The image shows the words "Prescription Use" and the phrase "(Per 21 CFR 801.109)" below it. There is a filled in circle to the left of the words "Prescription Use". There is also an arrow pointing down from the right.

OR

### Over-The-Counter Use

(Optional Format 1-2-96)

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