Identity
- Trade Name
- Accusil Putty (Soft) FDA UDI
- Generic Name
- Composite dental impression material FDA UDI
- Model / Reference
- 150ml FDA UDI
Identifiers
- Catalog Number
- 70003 FDA UDI
- Primary DI / UDI-DI
- D967700030 FDA UDI
- 510(k) Number
- K213244 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Composite dental impression material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3660 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Composite dental impression material
Accusil Putty (Soft) by Prevest Denpro Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Composite dental impression material.
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Cleared under the same submission
K213244 also covers:
- Accusil Bite Registration — PREVEST DENPRO LIMITED
- Accusil Bite Registration — PREVEST DENPRO LIMITED
- Accusil Bite Registration — PREVEST DENPRO LIMITED
- Accusil Bite Registration — PREVEST DENPRO LIMITED
- Accusil Combo Kit Putty + Light Body (Soft) — PREVEST DENPRO LIMITED
- Accusil Combo Kit Putty + Light Body (Soft) — PREVEST DENPRO LIMITED
- Accusil Heavy Body — PREVEST DENPRO LIMITED
- Accusil Heavy Body — PREVEST DENPRO LIMITED
- Accusil Heavy Body — PREVEST DENPRO LIMITED
- Accusil Heavy Body — PREVEST DENPRO LIMITED
- Accusil Heavy Body — PREVEST DENPRO LIMITED
- Accusil Heavy Body — PREVEST DENPRO LIMITED
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
- Prevest Denpro Limited
Sources (1)
- FDA UDI a679fe14-a333-49c6-b006-c5d7aeec7f40 34 fields · synced May 30, 2026