Identity
- Trade Name
- CUTTERSIL MUCOSA 1X140 ML FDA UDI
- Generic Name
- Polyether dental impression material FDA UDI
- Device Name
- Material Impression FDA UDI
- Model / Reference
- 65767011 FDA UDI
- Description
- Material Impression FDA UDI
Identifiers
- Catalog Number
- 65767011 FDA UDI
- Primary DI / UDI-DI
- J014657670110 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Polyether 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
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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polyether dental impression material
Cuttersil Mucosa 1x140 Ml by Kulzer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyether dental impression material.
- Ramitec™ — 3M Deutschland GmbH · Class II
- SKY SELECT — DANVILLE MATERIALS, LLC · Class II
- 3M™ ESPE™ Impregum™ Penta™ — 3M Deutschland GmbH · Class II
- Ramitec™ — 3M Deutschland GmbH · Class I
- Impregum™ Penta™ Soft Medium Body — 3M Deutschland GmbH · Class II
- Impregum™ Penta™ — 3M Deutschland GmbH · Class II
- Impregum™ F — 3M Deutschland GmbH · Class II
- ROYAL — DANVILLE MATERIALS, LLC · Class II
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
- Kulzer, Inc.
Sources (1)
- FDA UDI f0683e37-e84b-4075-9369-5a1f0ed1a01e 35 fields · synced Jun 8, 2026