Identity
- Trade Name
- TheraBite Bite Pad, Regular (4 pcs) EUDAMEDFDA UDI
- Generic Name
- Mastication muscle exerciser FDA UDI
- Device Name
- TheraBite bite pad EUDAMEDThe TheraBite Bite Pads are self-adhesive pads intended to protect the user’s teeth. FDA UDI
- Model / Reference
- PA001 EUDAMEDFDA UDI
- Description
- The TheraBite Bite Pads are self-adhesive pads intended to protect the user’s teeth. FDA UDI
Identifiers
- Catalog Number
- PA001 FDA UDI
- Primary DI / UDI-DI
- 07331791004834 EUDAMEDFDA UDI
- Basic UDI-DI
- 7331791-JAW-A-000-0001-QT EUDAMED
- Unit of Use DI
- 07331791016592 EUDAMED
- FDA Product Code
- ION FDA UDI
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
- GMDN Term
- Mastication muscle exerciser FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5370 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 6 Centimeter FDA UDI
TheraBite Bite Pad, Regular (4 pcs) by Atos Medical AB — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7331791-JAW-A-000-0001-QT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Atos Medical AB
- EUDAMED SRN
- SE-MF-000000725
Sources (2)
- EUDAMED 864f7468-7580-4d3a-b550-5bc4a1c423ef 61 fields · synced Jul 22, 2026
- FDA UDI 2c5de315-b050-48ad-b80a-d8399313248f 37 fields · synced May 27, 2026