BEL-CYPHER N

K110160 · Takara Belmont Corporation · MUH · Feb 17, 2011 · Dental

Device Facts

• Record ID: K110160
• Device Name: BEL-CYPHER N
• Applicant: Takara Belmont Corporation
• Product Code: MUH · Dental
• Decision Date: Feb 17, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The Bel-Cypher N dental panoramic 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 N is a digital dental panoramic X-ray system. It functions as an extraoral source X-ray generator to capture radiographic images of the dento-maxillofacial region. Used in dental clinics by dental professionals for examination and diagnosis of oral, jaw, and tooth pathologies. The system produces digital images for clinician review to support diagnostic decision-making and patient treatment planning.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Extraoral source digital X-ray system. Complies with IEC 60601-1 (1995), IEC 60601-1-1 (2000), IEC 60601-1-2 (2004), IEC 60601-1-3 (1994), IEC 60601-1-4 (1999), IEC 60601-2-7 (1998), IEC 60601-2-28 (1993), and IEC 60601-2-32 (1994).

Indications for Use

Indicated for dental patients requiring radiographic imaging of the dento-maxillofacial region for 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

• Bel-Cypher (090020)

Submission Summary (Full Text)

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

### 510(k) SUMMARY

Schiff & Company, located in West Caldwell, NJ and on behalf of Takara Belmont, USA, Inc., is submitting this Special 510(k) Premarket Notification for Bel-Cypher N. The Bel-Cypher N dental panoramic 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 N |
| Common or Usual Name: | System, X-ray, Extraoral source, digital |
| Classification Name: | Extraoral source x-ray system |
| Performance Standards: | IEC 60601-1 (1995), IEC 60601-1-1 (2000),<br>IEC 60601-1-2 (2004), IEC 60601-1-3 (1994),<br>IEC 60601-1-4 (1999), IEC 60601-2-7 (1998),<br>IEC60601-2-28 (1993), IEC60601-2-32 (1994) |

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 (1995), IEC 60601-1-1 (2000), IEC 60601-1-2 (2004), IEC 60601-1-3 (1994), IEC 60601-1-4 (1999), IEC 60601-2-7 (1998), IEC60601-2-28 (1993), IEC60601-2-32 (1994)

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

# Substantially Equivalent:

.

.

.

The Bel-Cypher is substantially equivalent to:

| DEVICE NAME | 510(k) NUMBER | MANUFACTURER |
|-------------|---------------|----------------|
| Bel-Cypher | 090020 | Takara Belmont |

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

Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room – WO66-G609 Silver Spring, MD 20993-0002

Takara Belmont Corporation % Mr. Kunihiko Sobue Product Manager Takara Belmont USA, Inc. 101 Belmont DR SOMERSET NJ 08873

Re: K110160

Trade/Device Name: Bel-Cypher N Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: January 18, 2011 Received: January 19, 2011

FFB 17 201

#### 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, 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR-Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

{3}------------------------------------------------

Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Mary S Postel

Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

### Enclosure

{4}------------------------------------------------

# Indication for Use

510(k) Number (if known):

Device Name: Bel-Cypher N

Indication for Use:

The Bel-Cypher N dental panoramic X-ray system is indicated for use as generator of radiographic images of the dento-maxilofacial region and is intended for dental examination and diagnosis of diseases of the tooth, jaw, 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)

hul D'Okn

(Division Sign-Off) Division of Radiological Device Office of In Vitro Diagnostic Device Evaluat

510K. K110160

Page 1 of 1