ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM

K040748 · Takara Belmont USA, Inc. · EHD · Jun 2, 2004 · Dental

Device Facts

• Record ID: K040748
• Device Name: ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM
• Applicant: Takara Belmont USA, Inc.
• Product Code: EHD · Dental
• Decision Date: Jun 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The ANA-BEL and ANA-BEL CM 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

ANA-BEL and ANA-BEL CM are extraoral X-ray systems used for dental imaging. Device generates radiographic images of dento-maxilofacial region for diagnosis of teeth, jaw, and oral structure diseases. Operated by dental professionals in clinical settings. System utilizes X-ray tube with maximum rated peak tube potential of 90 kV. Output consists of radiographic images used by clinicians to inform diagnostic and treatment decisions. Benefits include visualization of oral structures to facilitate accurate diagnosis.

Clinical Evidence

Bench testing only. Performance data provided to demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Extraoral source X-ray system; X-ray tube with maximum rated peak tube potential of 90 kV. Class II device.

Indications for Use

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

• X-Caliber Model 1000, X-Caliber CM Model 2000 (K900681)
• PLANMECA 2002 CC Proline Panoramic X-ray (K970812)

Submission Summary (Full Text)

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### SUBSTANTIAL EQUIVALENCE SUMMARY JUN - 2 2004

This summary follows the format of the FDA 510(k) Substantial Equivalence Decision Making Process document.

| EQUIVALENT (PREDICATE) DEVICE #1: | X-Caliber Model 1000, X-Caliber CM<br>Model 2000 |
|-----------------------------------|------------------------------------------------------|
| 510(k) Number | K900681 |
| Manufactured By: | TAKARA BELMONT USA, Inc.<br>Somerset, New Jersey |
| EQUIVALENT (PREDICATE) DEVICE #2: | PLANMECA 2002 CC Proline Panoramic<br>X-ray |
| 510(k) Number | K970812 |
| Manufactured By: | PLANMECA OY<br>Asentajankatu 6<br>Helsinki, FI 00880 |

#### A. Do the X-Ray Imaging Device have the same indications statements?

Yes. ANA-BEL and ANA-BEL CM, Takara X-Caliber and X-Caliber CM, and PLANMECA 2002 CC Proline Panoramic X-ray are intended for the following use:

- Generation of radiographic images of the dento-maxilofacial region for . dental examination and diagnosis of diseases of the teeth, jaw, and oral structures.

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### Do the X-Ray Imaging Device have the same technological characteristics, B.

### e.g., design, materials, etc.?

Yes. ANA-BEL and ANA-BEL CM, Takara X-Caliber and X-Caliber CM, and PLANMECA 2002 CC Proline Panoramic X-ray all employ X-ray tube with maximum rated peak tube potential of 90 kV. Please refer to the comparison table for specifications.

- C. Could the new characteristics affect safety and effectiveness? No.
- Do the new characteristics raise new types of safety or effectiveness D. questions?

No.

- Do acceptable scientific methods exist for assessing effects of the new E. characteristics?
Yes.

- Are performance data available to assess the effects of new characteristics? r. Yes.
#### G. Do performance data demonstrate equivalence?

Yes.

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## CONCLUSION:

The ANA-BEL and ANA-BEL CM, Takara X-Caliber and X-Caliber CM, and PLANMECA

2002 CC Proline Panoramic X-ray are substantially equivalent.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 2 2004

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Takara Belmont USA % Mr. Jean-Claude Amar Official Correspondent Schiff & Company 1129 Bloomfield Avenue WEST CALDWELL NJ 07006 Re: K040748 Trade/Device Name: ANA-BEL and ANA-BEL CM Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II

> Product Code: 90 EHD Dated: May 13, 2004 Received: May 14, 2004

Dear Mr. Amar:

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. 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

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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you vo organizatial equivalence of your device of your device to a legally promaticated predicated." The 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 If you desire spoolite at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Other of Complanos at (21CFR Part 807.97) you may obtain. 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,

Nancy C. Bryden

Nancy C. Brogdon Director. Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Device Name:

Not assigned yet ANA-BEL and ANA-BEL CM

Indications for Use:

. . . . .

The ANA-BEL and ANA-BEL CM 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.

**Prescription Use**

(Per 21 CFR 801 Subpart D)

Over-The-Counter Use

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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David A. Swanson

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

SUBMITTED BY SCHIFF & COMPANY, WEST CALDWELL, NJ

JC C:\Documents and Settings\Jean-Claude Amar\My Documents\TakaraBelmont\ANA-BEL\2004-03-15-Ana-Bel510k.doc