Identity
- Trade Name
- OraStretch® Bitepad Pack – Standard FDA UDI
- Generic Name
- Mastication muscle exerciser FDA UDI
- Device Name
- The OraStretch Bitepads are self-adhesive pads used with the OraStretch press device to cushion the user's teeth. This pack includes 4 pediatric sized bitepads. FDA UDI
- Model / Reference
- CR1055 FDA UDI
- Description
- The OraStretch Bitepads are self-adhesive pads used with the OraStretch press device to cushion the user's teeth. This pack includes 4 pediatric sized bitepads. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850056079068 FDA UDI
- FDA Product Code
- ION FDA UDI
- GMDN Term
- Mastication muscle exerciser FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 60 Millimeter FDA UDI
Category: Mastication muscle exerciser
OraStretch® Bitepad Pack – Standard by CranioMandibular Rehab, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- CranioMandibular Rehab, Inc.
Sources (1)
- FDA UDI 4ee7c658-b0f1-4e84-8aec-2f362e985072 35 fields · synced Jun 9, 2026