Prime&Bond Elect® Universal Dental Adhesive

FDA UDI

Class II (US FDA UDI)

by Dentsply International

Identity

Trade Name: Prime&Bond Elect® Universal Dental Adhesive FDA UDI
Generic Name: Dentine adhesive FDA UDI
Device Name: Prime&Bond Elect® Universal Dental Adhesive - Light Cure - Unit Dose Package (100) FDA UDI
Model / Reference: 634603 FDA UDI
Description: Prime&Bond Elect® Universal Dental Adhesive - Light Cure - Unit Dose Package (100) FDA UDI

Identifiers

Catalog Number: 634603 FDA UDI
Primary DI / UDI-DI: D0026346031 FDA UDI
510(k) Number: K041343 FDA UDI
K051463 FDA UDI
FDA Product Code: KLE FDA UDI
GMDN Term: Dentine adhesive 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

FDA UDI

Single Use

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Dentine adhesive

Prime&Bond Elect® Universal Dental Adhesive by Dentsply International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dentine adhesive.

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Peak Universal Bond — ULTRADENT PRODUCTS, INC. · Class II
E-ON — BENCO DENTAL SUPPLY CO. · Class II
PermaFlo DC — ULTRADENT PRODUCTS, INC. · Class II
SciPharm Cure-On Touch Orthodontic Adhesive — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
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Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class II

Cleared under the same submission

K041343 also covers:

K051463 also covers:

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: Dentsply International

Sources (1)

FDA UDI 11fc6fc5-6bc2-4ad3-945c-9d5ad0042427 38 fields · synced May 29, 2026