ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle are three stylized human profiles facing to the right, with flowing lines above them. Public Health Service OCT 2 6 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. William T. Cousins Area Manager Quality Assurance & Regulatory Affairs Dentsply International 901 West Oakton Street Des Plaines, Illinois 60018-1884 Re: K994211 Trade/Device Name: AcuCam® Intraoral Camera Sheath Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: December 1, 1999 Received: December 14, 1999 Dear Mr. Cousins: This letter corrects our substantially equivalent letter of February 14, 2000 regarding the product code. 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 (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 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. {1}------------------------------------------------ #### Page 2 - Mr. Cousins 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 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to continue 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Shiu-Lin, Ph.D. 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 {2}------------------------------------------------ K994211 # FEB 1 4 2000 ## Attachment 11: 510(k) Summary of Safety and Effectiveness AcuCam® Intraoral Camera Sheath This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92(c). | Submitter: | DENTSPLY International, Inc.<br>Gendex Dental X-ray Division<br>901 West Oakton Street<br>Des Plaines, IL 60018-1884 | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | William T. Cousins<br>Area Manger Quality Assurance & Regulatory Affairs<br>phone: (847) 640-4924<br>fax: (847) 640-4970 | | Date Prepared: | December 1, 1999 | | Device Name: | AcuCam® Intraoral Camera Sheath | | Common Name: | AcuCam Sheath | | Classification Name: | Dental Operative Device, EIA, 872.6640 | | Predicate Device: | Sanitherm Oral Disposable Thermometer Sheath, 510(k) K983406 | | Product Description: | The AcuCam Intraoral Camera Sheath is a single-use device intended<br>for use with intraoral camera systems. The intraoral camera handpiece<br>is inserted into the sheath prior to use. | - Indications for Use: The AcuCam Intraoral Camera Sheath is a single-use device intended for use with intraoral camera systems to prevent contamination of the camera handpiece with saliva and other bodily fluids. ## Rationale for Substantial Equivalence The AcuCam Intraoral Camera Sheath shares the same indications for use as the predicate device. It is manufactured with identical materials, manufacturing process, and inspection and test procedures. The difference between the AcuCam Intraoral Camera Sheath and the predicate device is the size. Biocompatibility of materials has been demonstrated. {3}------------------------------------------------ #### Safety and Effectiveness Information: There are no differences between the design or manufacture of the AcuCam Intraoral Camera Sheath and the predicate device that could affect effectiveness relative to the intended use. Biocompatibility testing was conducted in accordance with ISO 10993-5. # Conclusion: The AcuCam Intraoral Camera Sheath was found to be substantially equivalent to the predicate device. The AcuCam Intraoral Camera Sheath is substantially equivalent to the predicate device except that the AcuCam Intraoral Camera Sheath is larger in size. {4}------------------------------------------------ # Section 3: Intended Use | 510(k) Number (if known): | K994424 K994211 | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | DENTSPLY International, Inc. AcuCam® Intraoral Camera Sheath | | Indications for Use: | The AcuCam® Intraoral Camera Sheath is a single-use device intended for use with the various intraoral camera systems to prevent contamination of the camera handpiece with saliva and other bodily fluids. | #### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) .............................................................................................................................................................................. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-the-Counter Use (Optional Format 1-2-96) 000009 Olin S. Lin (Division Sign-Off) Division of Dental, Infection Cor and General Hospital 510(k) Number 3-1 ﺑ