ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM

K041834 · Takara Belmont USA, Inc. · MUH · Dec 3, 2004 · Dental

Device Facts

• Record ID: K041834
• Device Name: ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM
• Applicant: Takara Belmont USA, Inc.
• Product Code: MUH · Dental
• Decision Date: Dec 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The ADR Plus SSXI Imaging Device for X-ray systems such as X-CALIBER, X-CALIBER CM, ANA-BEL and ANA-BEL CM, a Solid State X-Ray Imaging Device is indicated for use as a generator of radiographic images of the dento-maxilofacial region and is intended to replace conventional radiographic film for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures.

Device Story

The ADR Plus SSXI is a solid-state X-ray imaging device designed to replace conventional radiographic film. It integrates with X-ray systems (e.g., X-CALIBER, ANA-BEL) to capture radiographic images of the dento-maxillofacial region. Used in dental clinical settings by dental professionals, the device transforms X-ray radiation into digital radiographic images. These images are displayed for the clinician to facilitate the diagnosis of dental, jaw, and oral pathologies. The system provides a digital alternative to film-based radiography, potentially improving workflow efficiency and diagnostic capabilities through digital image acquisition.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Solid-state X-ray imaging device; functions as an accessory/component for extraoral X-ray systems. Operates as a digital receptor for radiographic image generation. Class II device under 21 CFR 872.1800 (Product Codes: MUH, EHD, MQB).

Indications for Use

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

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and its head turned to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

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

Takara Belmont USA, Inc. Robert Schiff, Ph.D. President Schiff & Company 1129 Bloomfield Avenue WEST CALDWELL NJ 07006

AUG 21 2013

Re: K041834

Trade/Device Name: ADR Plus SSXI Imaging Device for X-ray Systems Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH, EHD, and MQB Dated: October 19, 2004 Received: October 20, 2004

Dear Dr. Schiff:

This letter corrects our substantially equivalent letter of December 3, 2004.

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

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

medical device-related adverse events) (21 CFR 803); and good manufacturing practice medious do roo realted as not be quality systems (QS) regulation (21 CFR Part 820). This letter requirences as bet form in and one device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nonicate 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 11 you desire spoolily darrow to your viro 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 Four inay 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,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

. AND ANA-

## INDICATIONS FOR USE STATEMENT

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

Not assigned yet ADR Plus SSXI Imaging Device for X-ray systems such as X-CALIBER, X-CALIBER CM, ANA-BEL and ANA-BEL CM

Indications for Use:

The ADR Plus SSXI Imaging Device for X-ray systems such as X-CALIBER, X-CALIBER CM, ANA-BEL and ANA-BEL CM, a Solid State X-Ray Imaging Device is indicated for use as a generator of radiographic images of the dento-maxilofacial region and is intended to replace conventional radiographic film for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures.

Prescription Use X

(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)

Nancyic broadon

(Division Sign-Off) ()
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K041834

SUBMITTED BY SCHIFF & COMPANY, WEST CALDWELL, NJ

JC \\Server\sorver\TakaraBetmont\SSXI\2004-07-01-SSXI-510k.doc