Kulzer

FDA UDI

Class I (US FDA UDI)

by Kulzer, Inc.

Identity

Trade Name: Kulzer FDA UDI
Generic Name: Dental impression material adhesive FDA UDI
Device Name: Universal Silicone Adhesive FDA UDI
Model / Reference: 65607758 FDA UDI
Description: Universal Silicone Adhesive FDA UDI

Identifiers

Catalog Number: 65607758 FDA UDI
Primary DI / UDI-DI: J014656077580 FDA UDI
FDA Product Code: EHY FDA UDI
GMDN Term: Dental impression material adhesive FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6880 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental impression material adhesive

Kulzer by Kulzer, Inc. — Class I — 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

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 I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Kulzer, Inc.

Sources (1)

FDA UDI 19ba5225-b525-46df-9f1f-b1fb5dac12d5 35 fields · synced Jun 8, 2026