Porcelain Repair

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 1108-

by Ultradent Products, Inc.

Identity

Trade Name: Porcelain Repair EUDAMEDFDA UDI
Generic Name: Dental etching solution FDA UDI
Device Name: Porcelain Repair EUDAMED
Porcelain Repair Kit FDA UDI
Model / Reference: 1108- EUDAMED
1108 FDA UDI
Description: Porcelain Repair Kit FDA UDI

Identifiers

Catalog Number: 1108 FDA UDI
Primary DI / UDI-DI: 00883205044990 EUDAMED
00883205034465 FDA UDI
Basic UDI-DI: 0883205-REF11085T EUDAMED
FDA Product Code: EIH FDA UDI
EMDN Code: Q01010402 ENAMEL-DENTINAL ETCHING MATERIALS EUDAMED
GMDN Term: Dental etching solution FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 872.6660 FDA UDI
Medical Purpose: Intended for professional dental use to prepare porcelain and silica-based dental restorative surfaces for adhesive bonding procedures through chemical etching and silane surface treatment. 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: Dental etching solution

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

Similar devices

Also classified as Dental etching solution.

Dento-Etch — Spident · Class IIa
Vivid TruEtch 10% Kit — PEARSON DENTAL SUPPLIES, INC. · Class II
DC Keramik Ätzgel — PRISMAN GmbH · Class I
MASTER-DENT — DENTONICS, INC.
OSE 8oz. Orthodontic Etching Gel - Blue — ORTHODONTIC SUPPLY & EQUIPMENT CO., INC. · Class II
ETCHANT — Pulpdent Corporation · Class II
Scotchbond™ Universal — 3M Deutschland GmbH · Class II
GC CERAMIC PRIMER II — Gc America 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 87138cf1-88a1-4d2c-bac5-8fc50937452f 36 fields · synced Jul 29, 2026
EUDAMED 2f44b9a9-ad1b-4796-a994-5c8b08c1b325 61 fields · synced Jul 29, 2026