Identity
- Trade Name
- COLTENE ADHESIVE FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Model / Reference
- 4410 FDA UDI
Identifiers
- Catalog Number
- 4410 FDA UDI
- Primary DI / UDI-DI
- 07640181478446 FDA UDI
- 510(k) Number
- K811666 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Silicone 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
No
FDA UDI
Category: Silicone dental impression material
Coltene Adhesive by Coltène/Whaledent AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Silicone dental impression material.
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- PERFECTO — CROWN DELTA CORP. · Class II
- Bona-Bite 50ml x 32 — DMP Dental Industry S.A. · Class I
Cleared under the same submission
K811666 also covers:
- COLTENE ADHESIVE — Coltène/Whaledent AG
- COLTEX EXTRAFINE — Coltène/Whaledent AG
- COLTEX MEDIUM — Coltène/Whaledent AG
- Pressure Spot lndicator — Coltène/Whaledent AG
- Pressure Spot lndicator — Coltène/Whaledent AG
- Speedex — Coltène/Whaledent AG
- Speedex — Coltène/Whaledent AG
- Speedex — Coltène/Whaledent AG
- Speedex — Coltène/Whaledent AG
- Speedex — Coltène/Whaledent AG
- Speedex — Coltène/Whaledent AG
- Speedex — Coltène/Whaledent AG
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
- Coltène/Whaledent AG
Sources (1)
- FDA UDI b246909e-1209-4eda-bd1d-be4ace8020e9 36 fields · synced Jun 6, 2026