Identity
- Trade Name
- COE® Adhesive FDA UDI
- Generic Name
- Dental impression material adhesive FDA UDI
- Device Name
- COE® ADHESIVE THINNER , 15mL FDA UDI
- Model / Reference
- 133921 FDA UDI
- Description
- COE® ADHESIVE THINNER , 15mL FDA UDI
Identifiers
- Catalog Number
- 133921 FDA UDI
- Primary DI / UDI-DI
- D6581339211 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Dental impression material adhesive 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental impression material adhesive
COE® Adhesive by Gc America Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental impression material adhesive.
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- 3M™ — 3M Deutschland GmbH · Class I
- Affinity™ Tray Adhesive — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. · Class I
- 3M™ Impregum™ — 3M Deutschland GmbH · Class I
- 3M™ — 3M Deutschland GmbH · Class I
- 3M™ — 3M Deutschland GmbH · Class I
- 3M™ ESPE™ Impregum™ — 3M Deutschland GmbH · Class I
- The Orthodontic Store — Young Innovations, Inc. · 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
- Gc America Inc.
Sources (1)
- FDA UDI 42ad39d8-a506-4456-895c-c31043e98f3f 35 fields · synced May 30, 2026