MDC Dental

FDA UDI

Class II (US FDA UDI)

by Mdc Dental

Identity

Trade Name: MDC Dental FDA UDI
Generic Name: Temporary dental crown/bridge FDA UDI
Device Name: Tone A3. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions. It is used in the elaboration of all kinds of temporary dental Provisionals: inlays, onlays, veneers, bridges and partial or total crowns. It can be used as a filling / relining material for precast and temporary composite and metal crowns. FDA UDI
Model / Reference: Bisacryl Nictone A3 Tone FDA UDI
Description: Tone A3. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions. It is used in the elaboration of all kinds of temporary dental Provisionals: inlays, onlays, veneers, bridges and partial or total crowns. It can be used as a filling / relining material for precast and temporary composite and metal crowns. FDA UDI

Identifiers

Primary DI / UDI-DI: 07506338300766 FDA UDI
510(k) Number: K991577 FDA UDI
FDA Product Code: EBG FDA UDI
GMDN Term: Temporary dental crown/bridge FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3770 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

FDA UDI

Over-the-Counter

Yes

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Temporary dental crown/bridge

MDC Dental by Mdc Dental — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Temporary dental crown/bridge.

Visalys Temp — Kettenbach GmbH & Co. KG · Class II
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VIPI BLOCK — Vipi Indústria, Comércio, Exportação e Importação de Produtos Odontológicos Ltda. · Class II
VIPI BLOCK — Vipi Indústria, Comércio, Exportação e Importação de Produtos Odontológicos Ltda. · Class II
IDODENTINE — UNION DENTAL SA · Class II
10TEMP — UNION DENTAL SA · Class II
Pure PMMA Disc — QUEST DENTAL MATERIAL CORPORATION · Class II
Pure PMMA Disc — QUEST DENTAL MATERIAL CORPORATION · Class II

Cleared under the same submission

K991577 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: Mdc Dental

Sources (1)

FDA UDI 57e22c5f-97ad-4510-a6c3-8de203e43d4f 36 fields · synced May 30, 2026