Peak Universal Bond

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 4551

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 Total-Etch Intro Kit FDA UDI
Model / Reference: 4551 EUDAMEDFDA UDI
Description: Peak Universal Bond Total-Etch Intro Kit FDA UDI

Identifiers

Catalog Number: 4551 FDA UDI
Primary DI / UDI-DI: 00883205045058 EUDAMED
00883205104250 FDA UDI
Basic UDI-DI: 0883205-REF455175 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.

SEPTODONT HZ IMAGE MH COMP L/C SYR KIT — Septodont · Class II
SciPharm Cure-On Touch Orthodontic Adhesive — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
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

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

Manufacturer

Manufacturer: Ultradent Products, Inc.

Sources (2)

FDA UDI b4d579c8-3628-4361-b3c6-35e666992a5e 36 fields · synced Jul 15, 2026
EUDAMED 21c6cdf9-ea1c-456f-a4a3-808a83362756 61 fields · synced Jul 15, 2026