Peak Universal Bond

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref S4551

by Ultradent Products, Inc.

Identity

Trade Name: Peak Universal Bond & Ultra-Etch EUDAMED
Peak Universal Bond FDA UDI
Generic Name: Dentine adhesive FDA UDI
Device Name: Peak Universal Bond EUDAMED
Peak Universal Bond Sample FDA UDI
Model / Reference: S4551 EUDAMEDFDA UDI
Description: Peak Universal Bond Sample FDA UDI

Identifiers

Catalog Number: S4551 FDA UDI
Primary DI / UDI-DI: 00883205045928 EUDAMED
00883205102058 FDA UDI
Basic UDI-DI: 0883205-REFS4551H5 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

Similar devices

Also classified as Dentine adhesive.

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E-ON — BENCO DENTAL SUPPLY CO. · Class II
Xeno® IV One Component Light Cured Self-Etching Dental Adhesive — Dentsply International · Class II
SciPharm Cure-On Touch Orthodontic Adhesive — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
SciPharm CuRay Eclipse Visible Light-Cured Orthodontic Adhesive — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class II
International Dental Supply Eclipse Visible Light-Cured Orthodontic Adhesive — SCIENTIFIC PHARMACEUTICALS, INC. · Class II

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 875939f7-4461-4e63-8863-41097553799f 36 fields · synced Aug 2, 2026
EUDAMED 58edacae-0147-4481-916e-946d93acdc0c 61 fields · synced Aug 2, 2026