Identity
- Trade Name
- Rubber Base Adhesive FDA UDI
- Generic Name
- Dental impression material adhesive FDA UDI
- Device Name
- Impression adhesive for Permlastic. FDA UDI
- Model / Reference
- 00674 FDA UDI
- Description
- Impression adhesive for Permlastic. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195062037979 FDA UDI
- 510(k) Number
- K003650 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 59 Milliliter FDA UDI
Category: Dental impression material adhesive
Rubber Base Adhesive by Kerr Corporation — 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
- COE® Adhesive — Gc America Inc. · Class II
- 3M™ — 3M Deutschland GmbH · Class I
- 3M™ ESPE™ Impregum™ — 3M Deutschland GmbH · Class I
Cleared under the same submission
K003650 also covers:
- Permlastic — KERR CORPORATION
- Permlastic — KERR CORPORATION
- Permlastic — KERR CORPORATION
- Permlastic — KERR CORPORATION
- Permlastic — KERR CORPORATION
- Permlastic — KERR CORPORATION
- Permlastic — KERR CORPORATION
- Permlastic — KERR CORPORATION
- Permlastic — KERR CORPORATION
- Permlastic — KERR CORPORATION
- Permlastic — KERR CORPORATION
- Permlastic — KERR CORPORATION
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
- Kerr Corporation
Sources (1)
- FDA UDI 03835bb9-e056-477e-bae9-8f5b7b7dfca1 37 fields · synced Jun 8, 2026