Identity
- Trade Name
- Patterson® FDA UDI
- Generic Name
- Composite dental impression material FDA UDI
- Device Name
- MATERIAL, TOOTH SHADE, RESIN FDA UDI
- Model / Reference
- 71258383 FDA UDI
- Description
- MATERIAL, TOOTH SHADE, RESIN FDA UDI
Identifiers
- Catalog Number
- 71258383 FDA UDI
- Primary DI / UDI-DI
- D6620712583832 FDA UDI
- 510(k) Number
- K182778 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Composite dental impression material 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Composite dental impression material
Patterson® by Patterson Dental Supply, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Bosworth Rimseal — Harry J. Bosworth Co. · Class II
- Accusil Heavy Body — PREVEST DENPRO LIMITED · Class II
- AxioSil Heavy Body — Axiodent Inc. · Class II
Cleared under the same submission
K182778 also covers:
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 |
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Manufacturer
- Manufacturer
- Patterson Dental Supply, Inc.
Sources (1)
- FDA UDI fbfb73be-fbcb-4efa-bcf1-15d8d0cd5db5 35 fields · synced Jun 6, 2026