Identity
- Trade Name
- SICAT OPTIMOTION FDA UDI
- Generic Name
- Custom-made mouthguard FDA UDI
- Device Name
- SICAT OPTIMOTION FDA UDI
- Model / Reference
- 10501 FDA UDI
- Description
- SICAT OPTIMOTION FDA UDI
Identifiers
- Catalog Number
- 10501 FDA UDI
- Primary DI / UDI-DI
- D776105010 FDA UDI
- 510(k) Number
- K143655 FDA UDI
- FDA Product Code
- MQC FDA UDI
- GMDN Term
- Custom-made mouthguard 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: Custom-made mouthguard
Sicat Optimotion by SiCAT GmbH & Co. KG — 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
- SiCAT GmbH & Co. KG
Sources (1)
- FDA UDI 470273c5-bf67-40c9-ac70-47ba9be8103f 36 fields · synced Jun 1, 2026