Identity
- Trade Name
- Comfort Splint FDA UDI
- Generic Name
- Mouthguard, reusable FDA UDI
- Device Name
- Device to alleviate pain caused by bruxing or clenching of teeth FDA UDI
- Model / Reference
- COMSPL FDA UDI
- Description
- Device to alleviate pain caused by bruxing or clenching of teeth FDA UDI
Identifiers
- Catalog Number
- COMSPL FDA UDI
- Primary DI / UDI-DI
- D745COMSPL0 FDA UDI
- 510(k) Number
- K121365 FDA UDI
- FDA Product Code
- MQC FDA UDI
- GMDN Term
- Mouthguard, reusable FDA UDI
Classification
- Device Class
- U 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mouthguard, reusable
Comfort Splint by Prismatik Dentalcraft, Inc. — Class U — 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 U | Pending data |
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Manufacturer
- Manufacturer
- Prismatik Dentalcraft, Inc.
Sources (1)
- FDA UDI 18ee733a-abae-465e-92f2-db795ac12a7a 37 fields · synced May 30, 2026