Peak Universal Bond

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref S4554

by Ultradent Products, Inc.

Identity

Trade Name: Peak Universal Bond & Peak SE Primer EUDAMED
Peak Universal Bond FDA UDI
Generic Name: Dentine adhesive FDA UDI
Device Name: Peak Universal Bond EUDAMED
Peak Universal Bond Sample SE FDA UDI
Model / Reference: S4554 EUDAMEDFDA UDI
Description: Peak Universal Bond Sample SE FDA UDI

Identifiers

Catalog Number: S4554 FDA UDI
Primary DI / UDI-DI: 00883205045911 EUDAMED
00883205102065 FDA UDI
Basic UDI-DI: 0883205-REFS4554HB EUDAMED
FDA Product Code: KLE FDA UDI
EMDN Code: Q01010104 DENTAL BONDING AGENTS EUDAMED
GMDN Term: Dentine adhesive FDA UDI

Classification

Device Class: Class III EUDAMED
Class II FDA UDI
Regulation Number: 872.3200 FDA UDI
Medical Purpose: Intended for professional dental use to provide adhesive bonding between tooth structure and direct or indirect dental restorative materials during restorative and prosthetic dental procedures. EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Peak Universal Bond by Ultradent Products, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Also classified as Dentine adhesive.

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Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class II
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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ultradent Products, Inc.

Sources (2)

FDA UDI 262117e8-c79b-4a64-a509-91110e8b3b6b 36 fields · synced Jun 19, 2026
EUDAMED fe233498-14e1-49ff-91a7-fd84d9357156 61 fields · synced Jun 19, 2026