VISTADENT AT COMPLETE, MODEL 3.1

K053010 · Dentsply Intl., Inc. · LLZ · Nov 22, 2005 · Radiology

Device Facts

• Record ID: K053010
• Device Name: VISTADENT AT COMPLETE, MODEL 3.1
• Applicant: Dentsply Intl., Inc.
• Product Code: LLZ · Radiology
• Decision Date: Nov 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

VISTADENT™ AT COMPLETE software is a digital database for storing, retrieving and printing images that also has the ability to perform image manipulation and cephalometric analysis.

Device Story

VISTADENT™ AT COMPLETE is an orthodontic imaging database software; stores, organizes, and retrieves digital patient images and x-ray records. Features include image resizing, cropping, rotating, and cephalometric analysis with auto-tracing capability; supports virtual treatment objectives. Operates as stand-alone software or interfaces with practice management and digital x-ray systems. Used in clinical settings by dental/orthodontic professionals. Output allows clinicians to visualize patient anatomy, perform measurements, and plan orthodontic treatment; facilitates clinical decision-making regarding patient care and treatment objectives.

Clinical Evidence

No clinical data provided; substantial equivalence supported by bench testing and comparison of technological characteristics to predicate devices.

Technological Characteristics

Software-based orthodontic image management system. Functions include database storage, image manipulation (resize, crop, rotate), and cephalometric analysis. Supports networking and integration with practice management and digital x-ray systems. Operates as stand-alone software.

Indications for Use

Indicated for use as a digital database for storing, retrieving, and printing orthodontic patient images and x-ray records, including image manipulation and cephalometric analysis.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• KODAK Orthodontic Imaging & OMS Imaging 8.0 (K043104)
• EagleSoft ChairSide Software Application (K982422)

Reference Devices

• Radco DentalEye 2 Dental Image Management System (K012439)

Submission Summary (Full Text)

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

## NOV 2 2 2005

K05301D

# 510(k) SUMMARY

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872

| CONTACT: | Helen Lewis |
|----------------------------|-------------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | October 21, 2005 |
| TRADE OR PROPRIETARY NAME: | VISTADENT™ AT COMPLETE |
| CLASSIFICATION NAME: | Extraoral source x-ray system, 872.1800 |
| PREDICATE DEVICES: | KODAK Orthodontic Imaging & OMS Imaging 8.0, K043104;<br>EagleSoft ChairSide Software Application, K982422; |

Radco DentalEye 2 Dental Image Management System, K012439

#### DEVICE DESCRIPTION:

VISTADENT™ AT COMPLETE software is designed for use as an imaging database for storage and organization of orthodontic patient digital images and x-ray records. Features include resizing, cropping, and rotating of images; data and image sharing with practice management systems and digital x-ray systems; cephalometric analysis with auto-tracing capability; and virtual treatment objectives. VISTADENT™ AT COMPLETE can operate as a stand-alone software or interface with other systems software.

INTENDED USE:

VISTADENT™ AT COMPLETE software is a digital database for storing, retrieving and printing images that also has the ability to perform image manipulation and cephalometric analysis.

#### TECHNOLOGICAL CHARACTERISTICS:

The VISTADENT™ AT COMPLETE storing, organizing, imaging, scanning, loading, tracing, analyzing, and networking functions are similar to other legally marketed orthodontic image systems. We believe that use of VISTADENT™ AT COMPLETE and the predicate devices, the similarities to the predicates, and the performance data support the safety and effectiveness of VISTADENT™ AT COMPLETE for the indicated uses.

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

Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape and features the department's emblem in the center. The emblem is a stylized representation of a bird or eagle, with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 2 2005

Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street YORK PA 07405-0872

Re: K053010

Trade/Device Name: VISTADENT™ at Complete Regulatory Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: LLZ Dated: October 21, 2005 Received: October 26, 2005

Dear Ms. Lewis:

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 (Premarket Approval), 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.

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

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 CVR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation prumber at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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,

Nancy C. Brogdon

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

Enclosure

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

### INDICATIONS FOR USE

510(K) Number (if known):

16 05 2010

VISTADENT™ AT COMPLETE Device Name:

Indications for Use:

VISTADENT™ AT COMPLETE software is a digital database for storing, retrieving and printing images that also has the ability to perform image manipulation and cephalometric analysis.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

9

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel H. Legum

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K053010

Premarket Notification

VISTADENT™ AT COMPLETE