Identity
- Trade Name
- KöR FDA UDI
- Generic Name
- Dental impression material adhesive FDA UDI
- Device Name
- KöR Impression Tray Adhesive is an adhesive developed specifically for durable adhesion of addition curing vinyl silicone impression materials to disposable impression trays and avoids lifting of the impression material from the tray when taking the impression out of the mouth. FDA UDI
- Model / Reference
- KöR Impression Tray Adhesive FDA UDI
- Description
- KöR Impression Tray Adhesive is an adhesive developed specifically for durable adhesion of addition curing vinyl silicone impression materials to disposable impression trays and avoids lifting of the impression material from the tray when taking the impression out of the mouth. FDA UDI
Identifiers
- Catalog Number
- 10-1008 FDA UDI
- Primary DI / UDI-DI
- 00850362007021 FDA UDI
- 510(k) Number
- K992001 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 — 10 Milliliter FDA UDI
Category: Dental impression material adhesive
Kör by Evolve Dental Technologies, 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
- 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
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
- Evolve Dental Technologies, Inc.
Sources (1)
- FDA UDI 6f9047b5-723a-4bc0-b3a4-50edc0fc360b 38 fields · synced Jun 6, 2026