Dream Systems is PDAC E0486 Medicare cleared for its Telescopic Sleep Herbst.
he Dream Systems Telescopic Sleep HerbstTM is FDA cleared for Sleep Apnea under Dream Systems, LLC for the Acrylic Splint Hinge Appliance FDA 510K 083209 01/02/2013. The Dream Systems Telescopic Sleep Herbst is EO486 PDAC cleared through Medicare (Herbst Oral Appliance MC1 Dream Systems LLC E0486 01/11/2013) Our Telescopic Herbst provides maximum tongue space, and exceptional freedom of movement, vertically and horizontally, though limited with elastics. The Telescopic hinges extend, but do not come apart.
The Herbst Screw design allows the doctor to advance the mandible in ¼ mm increments. One turn of the advancement mechanism (until the next hole appears) ad-vances the mandible about 1/16 mm. The arrows indicate the directions of advancement; Right side-up, Left side-down. Turns with the orthodontic key will allow for a maximum of 5mm with the standard Herbst Screw Hinges. If more adjustment is required, longer Herbst Screw Hinges can be provided for an additional 5mm extension or Extension Clips in 1mm, 2mm or 3mm.
Our Premium Telescopic Sleep Herbst uses the Schue Telecopic Screw Hinges. It has a fully-welded 044 wire framework, lingually and buccally, with Tunnel Pivots (Fig.1—No Surface Weld) for the buccal frame to handle the strong forces on the hinges, while strengthening the Vitacrylic HardFlex or Hard Acrylic splints.
Ball or Arrow clasps are added for extra retention. Directional Arrows are added. 6 ounce, 5/16″ elastics are included to limit jaw movement and minimize dislodgement of the splints. Ceka Bond is added to help keep Herbst Hex Screws from unscrewing during wear. A Hex Wrench is provided for periodic tightening and an orthodontic key for advancing the mandibular position.
Our Medicare Telescopic Sleep Herbst also uses the Schue Telecopic Screw Hinges and has a wire and welded framework. It also includes the Tunnel Pivots for strength, Ball / Arrow Clasps, Ball Hooks and Elastics, Directional Arrows and Ceka Bond is added to the Screws.