ACUCAM CONCEPT IV FWT, MODEL 110-0185G1

K032904 · Dentsply Intl. · EIA · Oct 14, 2003 · Dental

Device Facts

• Record ID: K032904
• Device Name: ACUCAM CONCEPT IV FWT, MODEL 110-0185G1
• Applicant: Dentsply Intl.
• Product Code: EIA · Dental
• Decision Date: Oct 14, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The AcuCam Concept IV Digital Dental Intraoral Camera System is a dental imaging system intended for use by health professionals in taking intraoral and extraoral images of dental anatomy.

Device Story

AcuCam Concept IV is a digital dental intraoral camera system used by dental practitioners in clinical settings. The device captures intraoral and extraoral images of dental anatomy. It consists of a handpiece assembly with a monocoil cable and a docking station (wall or counter-mounted). Optional peripherals include video monitors and printers. The system provides magnified, high-quality visual data to assist in assessing dental health, communicating treatment plans to patients, and documenting clinical findings for records or insurance. The practitioner operates the handpiece to visualize difficult-to-view regions of the oral cavity, facilitating patient education and visual confirmation of procedure outcomes.

Clinical Evidence

Bench testing only. Evidence includes performance testing to meet product specifications, software design/performance validation, and hazard analysis. No clinical trial data provided.

Technological Characteristics

Digital dental intraoral camera system. Components include a handpiece assembly with monocoil cable and a docking station. System supports integration with external monitors and printers. Operates as a dental operative unit (Product Code: EIA).

Indications for Use

Indicated for use by dental health professionals to capture intraoral and extraoral images of dental anatomy for assessment, patient education, treatment planning, documentation, and monitoring of dental procedures.

Regulatory Classification

Identification

A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.

Predicate Devices

• Gendex AcuCam Concept IV
• Vistacam Omni
• Vistacam Omni (IC)
• Ultracam

Submission Summary (Full Text)

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

# OCT 1 4 2003

Image /page/0/Picture/1 description: The image shows the logos for Dentsply and Gendex. The Dentsply logo is in a bold, sans-serif font, with a stylized "P" that has a triangular cutout. Below Dentsply, the Gendex logo is displayed in a simpler, sans-serif font. Both logos are in black and are positioned one above the other.

K032904

DENTSPLY International Gendex Division 901 West Oakton Street Des Plaines, IL 60018-1884 Phone [phone] Fax [phone]

## 510(k) Summary Statement for the Gendex AcuCam Concept IVFMT Digital Dental Intraoral Camera System

| I. | General Information | |
|-----|------------------------------|-------------------------------------------------------------------------------------------|
| | Submitter: | DENTSPLY International<br>Gendex Division<br>901 West Oakton St.<br>Des Plaines, IL 60018 |
| | Telephone: | [phone] – Company Number<br>[phone] - Contact Person |
| | Fax: | [phone] |
| | Contact Person: | John R. Miller<br>Director, Quality Assurance and Regulatory Affairs |
| | Summary Preparation Date: | September 16, 2003 |
| II. | Names | |
| | Device Name: | AcuCam Concept IV ^FWT Digital Dental Intraoral<br>Camera System |
| | Primary Classification Name: | EIA - Dental Operative Unit |

### III. Predicate Devices

- Gendex AcuCam Concept IV Intraoral Camera System .
- . Vistacam Omni and Vistacam Omni (IC)
- . Ultracam

### IV. Product Description

The DENTSPLY International, Gendex Division AcuCam Concept IVf"" Digital Dental Intraoral Camera System is an imaging device that is intended for use in taking intraoral and extraoral images.

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

The DENTSPLY International, Gendex Division AcuCam Concept IVF™™ Digital Dental Intraoral Camera System is comprised of the following main components:

- Docking station (wall mounted, or counter top) .
- Handpiece assembly with monocoil cable .

Optional components:

- Video monitor .
- Printer .

### V. Indications for Use / Rationale for Substantial Equivalence

The AcuCam Concept IVFWT Digital Dental Intraoral Camera System is an imaging device, which is intended for use by health professionals in taking intraoral and extraoral images of dental anatomy in order to:

- 1. To assist the dental practitioner in the assessment of the overall dental health of the patient by providing high quality, magnified images of regions of the oral cavity which otherwise are difficult or impossible to view.
- 2. Allow the dental practitioner to provide educational information to the patient and to more effectively communicate a treatment plan.
- 3. Provide documented images for patient records, insurance companies, and health professionals.
- 4. To allow the practitioner to provide before and after color images showing the results of the dental procedures performed.

The end user must insure that any peripheral equipment (i.e., monitor, printer, computer, etc.) used with the AcuCam Concept IV Digital Dental Intraoral Camera System is approved for medical applications under the respective national regulations.

It shares the same indications for use, similar materials, design, operational, and functional features and therefore is substantially equivalent to the predicate devices listed in Section III of this summary.

### VI. Safety and Effectiveness Information

Safety and Effectiveness is demonstrated by:

- -Performance testing to meet product/specifications
- Software testing to validate software design / performance ﺴ
- Effective clinical image exposures -
- ﻴﻨ Hazard analysis including risk level and solution
- Same indications for use as predicate devices. "

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

All the aforementioned steps and evaluations combine to demonstrate that the AcuCam Concept IVEWT Digital Dental Intraoral Camera System is safe and effective when the device is used as labeled.

#### VII. Conclusion

The AcuCam Concept IVF™T Digital Dental Intraoral Camera System was found to be Substantially Equivalent to the predicate devices; the Gendex AcuCam Concept IV, the Air Techniques Vistacam Omni and Vistacam Omni (IC), and Mr. W. Edward Johansen's Ultracam. The AcuCam Concept IVF"" Digital Dental Intraoral Camera System shares the same indications for use, similar materials, design, operational, and functional features as the current marketed predicate devices. It has been shown to be safe and effective when used as labeled.

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 4 2003

Mr. John R. Miller Director Quality Assurance and Regulatory Affairs Dentsply International 901 West Oakton Street Des Plaines, Illinois 60018-1884

Re: K032904

Trade/Device Name: AcuCam Concept IV™ Digital Intraoral Camera System Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: September 16, 2003 Received: September 25, 2003

Dear Mr. Miller:

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.

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

Page 2 -Mr. Miller

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 (OS) 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 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 Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 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/dsma/dsmamain.html

Sincerely yours.

Cluiz

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

510(k) Number (if known): Not Assigned

AcuCam Concept IVFWT Digital Dental Intraoral Camera System Device Name:

### Indications for Use:

The AcuCam Concept IVF"T Digital Dental Intraoral Camera System is a dental imaging system intended for use by health professionals in taking intraoral and extraoral images of dental anatomy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suser Runser

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental De

510(k) Number: K032904

Prescription Use (Per 21CFR 801.109)

OR

Over-The-Counter Use __

(Optional Format 1-2-96)

000036