Be sure with this administration to pay for your FDA class @ license, and have your facility up to FDA Standards. Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Apnea; That the material has gone thru the extended biocompatibility testing as outlined in the FDA-modified or a surface device that contacts intraoral (i.e., mucosal, gingival, and palatal) surfaces for prolonged contact. Your summary report should contain a statement that testing will be conducted as described in Parts 5 and 10 of ISO-10993 the standard (the statement should also include the acceptance criteria to be applied).