Identity
- Trade Name
- CAMouflage FDA UDI
- Generic Name
- Custom-made dental composite resin kit FDA UDI
- Device Name
- CAMouflage NOW Milling Blocks & Bonding Kit C-Mandrel A1 HT FDA UDI
- Model / Reference
- 70-1000-CMN0016 FDA UDI
- Description
- CAMouflage NOW Milling Blocks & Bonding Kit C-Mandrel A1 HT FDA UDI
Identifiers
- Catalog Number
- 70-1000-CMN0016 FDA UDI
- Primary DI / UDI-DI
- D745701000CMN00160 FDA UDI
- 510(k) Number
- K160425 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Custom-made dental composite resin kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Custom-made dental composite resin kit
CAMouflage by Prismatik Dentalcraft, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K160425 also covers:
- CAMouflage — PRISMATIK DENTALCRAFT, INC.
- CAMouflage — PRISMATIK DENTALCRAFT, INC.
- CAMouflage — PRISMATIK DENTALCRAFT, INC.
- CAMouflage — PRISMATIK DENTALCRAFT, INC.
- CAMouflage — PRISMATIK DENTALCRAFT, INC.
- CAMouflage — PRISMATIK DENTALCRAFT, INC.
- CAMouflage — PRISMATIK DENTALCRAFT, INC.
- CAMouflage — PRISMATIK DENTALCRAFT, INC.
- CAMouflage — PRISMATIK DENTALCRAFT, INC.
- CAMouflage — PRISMATIK DENTALCRAFT, INC.
- CAMouflage — PRISMATIK DENTALCRAFT, INC.
- CAMouflage — PRISMATIK DENTALCRAFT, INC.
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Prismatik Dentalcraft, Inc.
Sources (1)
- FDA UDI c21b1069-b294-4f8b-abf7-9c4ca89a5dcf 37 fields · synced May 30, 2026