FDA.reportPublic FDA data

Mastication muscle exerciser

Definition
An intraoral mechanical exercise apparatus intended primarily to strengthen and rehabilitate the jaw muscles of mastication of a patient who has pain in, or disorders of, the temporomandibular joint (TMJ), typically through repetitive biting against resistive forces provided by the device. This is a reusable device.
GUDID devices
42
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07331791004834TheraBite Bite Pad, Regular (4 pcs)Atos Medical ABPA0012022-11-28
07331791004841TheraBite Bite Pad, Edentulous (4 pcs)Atos Medical ABPA0022022-11-28
07331791004858TheraBite Bite Pad, Pediatric (4 pcs)Atos Medical ABPA0032022-11-28
07331791004865TheraBite Range of Motion Scale (150 pcs)Atos Medical ABSC0012022-11-29
00860014768620MouthflexINNOMOTIVE L.L.CMF1002026-02-11
D90970060010ORTHO ARCHOrtho Arch Company Inc700-6002025-08-27
D90970060111ORTHO ARCHOrtho Arch Company Inc700-6012025-08-27
D90970060212ORTHO ARCHOrtho Arch Company Inc700-6022025-08-27
D90970060313ORTHO ARCHOrtho Arch Company Inc700-6032025-08-27
D90970060414ORTHO ARCHOrtho Arch Company Inc700-6042025-08-27
D90970060515ORTHO ARCHOrtho Arch Company Inc700-6052025-08-27
D90970060616ORTHO ARCHOrtho Arch Company Inc700-6062025-08-27
D90970060919ORTHO ARCHOrtho Arch Company Inc700-6092025-08-27
D90970061011ORTHO ARCHOrtho Arch Company Inc700-6102025-08-27
D90970061112ORTHO ARCHOrtho Arch Company Inc700-6112025-08-27
D90970061213ORTHO ARCHOrtho Arch Company Inc700-6122025-08-27
D90970061314ORTHO ARCHOrtho Arch Company Inc700-6132025-08-27
D90970061718ORTHO ARCHOrtho Arch Company Inc700-6172025-08-27
00850056079051OraStretch® Bitepad Pack – StandardCranio Mandibular Rehab, Inc.CR10502024-04-01
00850056079068OraStretch® Bitepad Pack – StandardCranio Mandibular Rehab, Inc.CR10552024-04-01
00850056079075OraStretch® Bitepad Pack – StandardCranio Mandibular Rehab, Inc.CR10572024-04-01
00850056079082OraStretch® Power Band PackCranio Mandibular Rehab, Inc.CR10702024-04-01
00850056079099OraStretch® Jaw ROM Scale PackCranio Mandibular Rehab, Inc.CR10802024-04-01
00850056079105OraStretch® Deflection Deviation ScalesCranio Mandibular Rehab, Inc.CR10832024-04-01
00850056079129OraStretch® Jaw MIO Plastic ScaleCranio Mandibular Rehab, Inc.CR10872024-04-01
00850056079136OraMPA™ Microstomia ApplianceCranio Mandibular Rehab, Inc.CR17302024-04-01
00850056079143OraMPA™ Microstomia Appliance - Severe Extra SmallCranio Mandibular Rehab, Inc.CR17352024-04-01
00850056079150OraMPA™ Dynamic Band PackCranio Mandibular Rehab, Inc.CR17412024-04-01
00850056079167OraMPA™ Static Wrap PackCranio Mandibular Rehab, Inc.CR17432024-04-01
00850056079396OraStretch® Jaw MIO Scale PackCranio Mandibular Rehab, Inc.CR10852024-04-01
00850056079402OraMPA™ Microstomia Appliance - XL Semi-CircumferentialCranio Mandibular Rehab, Inc.CR17332024-04-01
00850056079006OraStretch® Press Device – StandardCranio Mandibular Rehab, Inc.CR10002023-10-05
00850056079020OraStretch® Press Device – AnteriorCranio Mandibular Rehab, Inc.CR10032023-10-05
00850056079037OraStretch® Press Device – PediatricCranio Mandibular Rehab, Inc.CR10052023-10-05
00850056079044OraStretch® Extended Clip-On MouthpieceCranio Mandibular Rehab, Inc.CR10072023-10-05
07331791004827TheraBite ActiveBand KitAtos Medical AB82602022-11-29
07331791016622TheraBite Range of Motion ScaleAtos Medical ABSC0012022-11-29
07331791004872TheraBite Jaw Motion Rehabilitation System, AdultAtos Medical ABTH0012022-11-28
07331791004889TheraBite Jaw Motion Rehabilitation System, PediatricAtos Medical ABTH0022022-11-28
07331791016592TheraBite Bite Pad, RegularAtos Medical ABPA0012022-11-28
07331791016608TheraBite Bite Pad, EdentulousAtos Medical ABPA0022022-11-28
07331791016615TheraBite Bite Pad, PediatricAtos Medical ABPA0032022-11-28