BEL-CYPHER, MODEL Y977

K090020 · Takara-Belmont Co., Ltd. · MUH · Mar 13, 2009 · Dental

Device Facts

• Record ID: K090020
• Device Name: BEL-CYPHER, MODEL Y977
• Applicant: Takara-Belmont Co., Ltd.
• Product Code: MUH · Dental
• Decision Date: Mar 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The Bel-Cypher dental panoramic and cephalometric X-ray system is indicated for use as a generator of radiographic images of the dento-maxilofacial region and is intended for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures.

Device Story

Bel-Cypher is a digital dental panoramic and cephalometric X-ray system. It functions as an extraoral X-ray source to generate radiographic images of the dento-maxillofacial region. Used in dental clinical settings, the device is operated by dental professionals to assist in the examination and diagnosis of diseases affecting teeth, jaws, and oral structures. The system captures X-ray data, which is processed to produce digital images for clinician review. These images support clinical decision-making by providing visual diagnostic information regarding oral anatomy and pathology, potentially benefiting patients through improved diagnostic accuracy for dental conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Extraoral digital X-ray system; Class II (21 CFR 872.1800). Complies with IEC 60601-1-4 (1996), IEC 60601-1-4 (Form D-018/D-019-1), and ISO 14971 (2007).

Indications for Use

Indicated for dental patients requiring radiographic imaging of the dento-maxillofacial region for the examination and diagnosis of diseases of the teeth, jaw, and oral structures.

Regulatory Classification

Identification

An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

Predicate Devices

• ANA-BEL (040748)

Submission Summary (Full Text)

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## SUMMARY

MAR 1 3 2009

Schiff & Company, located in West Caldwell, NJ and on behalf of Takara Belmont, USA, Inc., is submitting this 510(k) Premarket Notification for Bel-Cypher. The Bel-Cypher dental panoramic and cephalometric X-ray system is indicated for use as a generator of radiographic images of the dento-maxilofacial region and is intended for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures.

Device Details:

| Device Class: | CFR 872.1800 identifies the device as an<br>Extraoral source x-ray system, Class II |
|----------------------------|--------------------------------------------------------------------------------------------------------|
| Trade or Proprietary Name: | Bel-Cypher |
| Common or Usual Name: | System, X-ray, Extraoral source, digital |
| Classification Name: | Extraoral source x-ray system |
| Performance Standards: | IEC 60601-1-4 (Form D-019-1), IEC 60601-1-4<br>(1996), ISO 14971 (2007), IEC 60601-1-4<br>(Form D-018) |

Labeling:

Copies are included with this submission.

Establishment Details:

Establishment Registration No: 96114485

Takara Belmont USA, Inc. Belmont Equipment Division 101 Belmont Drive Somerset, NJ 08873-1204

Performance Compliance:

IEC 60601-1-4 (Form D-019-1), iEC 60601-1-4 (1996), ISO 14971 (2007), IEC60601-1-4 (Form D-018)

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## Substantially Equivalent:

The Bel-Cypher is substantially equivalent to:

| DEVICE NAME | 510(K) Number<br>STATE LA PARTY & STANLAN | STATISTICS OF THE OFFICE OF CONSULTION OF CHEARTH OF CHEARTH OF CHEARTH AND THE OFFICE OF CHEARTH AND THE OFFICE OF CHEARTH AND THE FORM OF CHEARTH AND THE OFFICE AND THE OF<br>MANUFACTURER |
|-------------|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ANA-BEL | 040748 | Takara Belmont |

Comparison of the Bel-Cypher to the ANA-BEL and Generic X-Ray Film/Screen appears in Attachment 3 of this submission.

Installation, operating instructions, care and maintenance are also included with this submission.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2009

TAKARA Belmont Corporation % Mr. Kunihiko Sobue Product Manager TAKARA Belmont USA, Inc. 101 Belmont Drive SOMERSET NJ 08873-1204

Re: K090020

Trade/Device Name: Bel-Cypher Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: January 2, 2009 Received: January 5, 2009

Dear Mr. Sobue:

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. Drue, 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.

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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. 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 (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) premarket notification. The FDA finding os 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 one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. Youmay obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.

Sincerely yours,

Laura B. Morris

anine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indication for Use

510(k) Number (if known):

K090020

Device Name: Bel-Cypher

Indicaiton for Use:

The Bel-Cypher dental panoramic and cephalometric X-ray system is indicated for use as a generator of radiographic images of the dento-maxilofacial region for use a generator of rainomination and diagnosis of diseases of the teeth, iaw, and oral structures.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Offic of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

IND