Identity
- Trade Name
- SML FDA UDI
- Generic Name
- Custom-made mouthguard FDA UDI
- Device Name
- The POD FDA UDI
- Model / Reference
- 62065 FDA UDI
- Description
- The POD FDA UDI
Identifiers
- Primary DI / UDI-DI
- D854620651 FDA UDI
- 510(k) Number
- K182820 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
Yes
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Custom-made mouthguard
Sml by Selane Products, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- BENCO — BENCO DENTAL SUPPLY CO. · Class I
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
- Selane Products, Inc.
Sources (1)
- FDA UDI 92572acc-87f4-4b8b-9461-60e53a70e24b 34 fields · synced Jun 6, 2026