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Gluma Desensitizer Single Dose 40x1 Pce

FDA UDI

Class II (US FDA UDI)

by Kulzer, Inc.

Identity

Trade Name
GLUMA DESENSITIZER SINGLE DOSE 40X1 PCE FDA UDI
Generic Name
Dentine bonding agent/set FDA UDI
Device Name
Agent, tooth bonding resin FDA UDI
Model / Reference
66001854 FDA UDI
Description
Agent, tooth bonding resin FDA UDI

Identifiers

Catalog Number
66001854 FDA UDI
Primary DI / UDI-DI
J014660018540 FDA UDI
510(k) Number
K962812 FDA UDI
FDA Product Code
KLE FDA UDI
GMDN Term
Dentine bonding agent/set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3200 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: Dentine bonding agent/set

Gluma Desensitizer Single Dose 40x1 Pce by Kulzer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dentine bonding agent/set.

Cleared under the same submission

K962812 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kulzer, Inc.

Sources (1)

  • FDA UDI ce72d228-a5f2-45c0-b664-84ca5d8fcb06 36 fields · synced May 30, 2026