ENDSNOR

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the text "510(k) Summary" in a bold, sans-serif font. The text is black against a white background. The text is likely a title or heading for a document or section of a document. April 23, 2008 JUN 1 2 2008 Dockstader Orthodontic Lab, Inc. 340 West Cromwell Fresno, CA 93711 Establishment Registration Number: 510(k) Number: SBD070202 K072731 Contact Person: Michael C Bausman (559) 439-5160 Telephone: Fax: (559) 439-8147 #### Device | Trade Name: | EndSnor™ | |----------------------|---------------------------------| | Common Name: | Anti-Snoring/Sleep Apnea Device | | Classification Name: | Device, Anti-Snoring | | Product Code: | LRK | | Class: | II | | Regulation Number: | 872.5570 | Description of Device: The EndSnor™ device is a dentist prescribed one-piece anti-snoring/sleep apnea appliance, custom-fit to patients' teeth by a professional dentist. It consists of an acrylic upper and lower posterior bite registration with an acrylic overlay of the posterior teeth, finished to the buccal/lingual height of contour for retention. If needed, the dentist may request stainless steel ball clasps, commonly used in the fabrication of orthodontic appliances, be added for more retention. Four expansion screws, commonly used in the fabrication of orthodontic appliances, are set in the acrylic to allow for mandibular readjustment. Mandibular adjustments are made by turning each screw equally. A labial supporting bar, commonly used in the fabrication of orthodontic appliances, is used to bridge the anterior gap in order to allow for less obstruction of the airway, and to remove the occurrence of loosening or harming of lower anterior teeth. Image /page/0/Picture/10 description: In the image, a cartoon drawing shows a person sitting in a container filled with what appears to be rocks or debris. The person is lying down and seems to be relaxing or lounging amidst the rocks. The container is a hexagonal shape and is overflowing with the contents. There are also some objects or debris falling out of the container. 340 West Cromwell, Suite 102 California 93711-611 19-5160 Tolf Free Inside U.S.A 1-800/433-7168 559/439-8147 Intended Use Statement: The EndSnor™ appliance, a dentist prescribed mandibular repositioning (MRP) device, is worn during sleep and is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or mild to moderate obstructive sleep apnea. Before a dentist prescribes an EndSnor" appliance for treatment, it is recommended that the patient receive a medical examination including a sleep study diagnosis, and a dental examination including cephalometric and tomography analysis to determine the need for an EndSnor" appliance. {1}------------------------------------------------ ### Identification of Legally Marketed Device, (predicate) for Substantial Equivalence: Name: Adjustable PM Positioner K Number: K922203 Date Cleared: 02/08/1996 ### Technological Characteristics Summary: Similarities between both devices are the following: - Indications for use . - . Function (MRP) - Mandibular Repositioning Device - . Single Patient - Multi-Use . - Prescription Device - Custom Fabricated (Fit) from Common Orthodontic Appliance Materials . - Adjustable . - Environment Home/Sleep Laboratories . - . Removable . - Non Sterile . ### Comparison to Predicate Device | Attribute | EndSnorTM | Adjustable PM Positioner | |--------------------------------------------------------------------------------------------------------------------------|-----------|--------------------------| | Use: | | | | Intended as a Dentist<br>prescribed intraoral device | YES | YES | | Intended to reduce<br>or help snoring and<br>minor to moderate<br>obstructive sleep apnea | YES | YES | | Intended for use with<br>patients 18 years or older<br>who snore or have minor<br>to moderate obstructive<br>sleep apnea | YES | YES | | Indicated for single<br>patient multi-use | YES | YES | | Attribute | EndSnor™™ | Adjustable PM Positioner | | Use cont: | | | | Indicated for use at<br>home or sleep<br>laboratories | YES | YES | | Design: | | | | Custom fit for each<br>user | YES | YES | | Mandible can be<br>advanced with buccal<br>expansion screws | YES | YES | | Expansion screw<br>placement on buccal<br>for unobstructed airway<br>passage | YES | YES | | Permits user to<br>breath through mouth,<br>opens the airway | YES | YES | | Acrylic fits over<br>upper and lower<br>posterior teeth | YES | YES | | Anterior Acrylic<br>connector over upper<br>and lower anterior teeth | NO | YES | | Attribute | EndSnor™ | Adjustable PM Positioner | | Design cont: | | | | Anterior connector<br>on labial using<br>dental lingual bar<br>for orthodontic splints | YES | NO | | Prevents grinding<br>of teeth | YES | YES | | Easily removed<br>from mouth | YES | YES | | Placed in users<br>mouth each evening | YES | YES | | Cleaned daily | YES | YES | | Materials: | | | | Dental expansion<br>screws for mandibular<br>adjustment | YES | YES | | Non-Sterile | YES | YES | | Acrylic | YES | YES | | Heat-sensitive acrylic | NO | YES | | Retention clasps for<br>retention if needed | YES | NO | | Dental lingual bar<br>for splints | YES | NO | {2}------------------------------------------------ ে কি . 博体 Antinetis # Comparison to Predicate Device cont: · {3}------------------------------------------------ 。 # Comparison to Predicate Device cont: {4}------------------------------------------------ ### Differences Between EndSnor™ and Adjustable PM Positioner, a Marketed Predicated Device ### Differences are: - EndSnor™ has 4 buccal expansion screws instead of 2 for mandible . advancement. - A labial supporting dental lingual bar for orthodontic splints is used to bridge the . anterior gap on the labial instead of acrylic over the anterior upper and lower teeth, thus creating less obstruction of the airway and to remove the occurrence of loosening or harming of lower anterior teeth. The labial supporting dental lingual bar is placed so there isn't any contact with the lower or upper anterior teeth. - . EndSnor™ is made of cold cure splint acrylic that is commonly used in dental labs for orthodontic splint fabrication. The Adjustable PM Positioner is made of a heat sensitive acrylic. - The dentist can chose to add retention clasps if needed for retention of the ● EndSnor™ appliance in the mouth. These commonly used orthodontic retainer clasps are Ball Clasps. These are made of stainless steel wire commonly used in the fabrication of orthodontic appliances. ### Safety and Efficacy: - The EndSnor™ device is similar to the Adjustable PM Positioner, a marketed . predicated device, both are mandibular repositioning devices (MRP) and both are similar in design and function. The difference between the EndSnor™ and the Adjustable PM Positioner, a predicated device, are minor and do not raise any new safety concerns or risks. - Literature supports the historical significance of oral devices that reposition the . mandible and reduce and mange snoring as well as mild to moderate sleep apnea. {5}------------------------------------------------ Image /page/5/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" arranged around the perimeter. Inside the circle is a stylized eagle emblem, with its wings forming a protective shape. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 1 2 2008 Mr. Michael C. Bausman Chief Executive Officer Dockstader Orthodontic Lab, Incorporated 340 West Cromwell Fresno, California 93711-6113 Re: K072731 Trade/Device Name: EndSnor™ Regulation Number: 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices For Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: April 25, 2008 Received: April 25, 2008 Dear Mr. Bausman; 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. {6}------------------------------------------------ Page 2 - Mr. Bausman 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 CIFR 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 (240) 276-. 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/industry/support/index.html. Sincerely vours. Sutte y. Michien Dm.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 {7}------------------------------------------------ ### Indications for Use 510(k) Number (if known): K072731 Device Name: _EndSnor™ Intended Use Statement: The EndSnor™ appliance, a dentist prescribed mandibular repositioning (MRP) device, is worn during sleep and is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or mild to moderate obstructive sleep apnea. Before a dentist prescribes an EndSnor " appliance for treatment, it is recommended that the patient receive a medical examination including a sleep study diagnosis, and a dental examination including cephalometric and tomography analysis to determine the need for an EndSnor™ appliance. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) 07273 Melle fer MSR Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: