Sample Ionosit Baseliner

FDA UDI

Class II (US FDA UDI)

by DMG Chemisch-Pharmazeutische Fabrik GmbH

Identity

Trade Name: Sample Ionosit Baseliner FDA UDI
Generic Name: Dental composite resin FDA UDI
Device Name: Light-curing compomer base liner. Gap-free restorations. Content: 1 Saferinge @ 0,3 g paste FDA UDI
Model / Reference: 2291 FDA UDI
Description: Light-curing compomer base liner. Gap-free restorations. Content: 1 Saferinge @ 0,3 g paste FDA UDI

Identifiers

Catalog Number: 2291 FDA UDI
Primary DI / UDI-DI: EDMG22911 FDA UDI
510(k) Number: K935689 FDA UDI
FDA Product Code: EBD FDA UDI
GMDN Term: Dental composite resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3310 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental composite resin

Sample Ionosit Baseliner by DMG Chemisch-Pharmazeutische Fabrik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
Llis — Dentscare Ltda · Class II
Capo Universal, 6 g — Schütz Dental GmbH · Class II
OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II

Cleared under the same submission

K935689 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: DMG Chemisch-Pharmazeutische Fabrik GmbH

Sources (1)

FDA UDI c9e192b1-bc9b-4f12-ae9e-1bc7729e33d8 37 fields · synced May 30, 2026