Nic Tone, MDC Dental

FDA UDI

Class II (US FDA UDI)

by Mdc Dental

Identity

Trade Name: Nic Tone, MDC Dental FDA UDI
Generic Name: Temporary dental crown/bridge resin FDA UDI
Device Name: Acrylic Temporary Resin for dental use, Tone BLEACH. Content: 1 Cartridge, with 76 g + 10 mixing tips. FDA UDI
Model / Reference: Bisacryl FDA UDI
Description: Acrylic Temporary Resin for dental use, Tone BLEACH. Content: 1 Cartridge, with 76 g + 10 mixing tips. FDA UDI

Identifiers

Primary DI / UDI-DI: 07506338300322 FDA UDI
510(k) Number: K991577 FDA UDI
FDA Product Code: EBG FDA UDI
GMDN Term: Temporary dental crown/bridge resin 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 resin

Nic Tone, 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 resin.

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UNIFAST™ — Gc America Inc. · Class II
MODIFYING STAIN — AMERICAN TOOTH INDUSTRIES · Class II
DENTURE BASE — AMERICAN TOOTH INDUSTRIES · Class II
PORTUX CAD/CAM Disc. 98.5X 25mm C2. MN — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A · Class II
tempofit premium BL — DETAX GmbH · Class II
YAMAHACHI PMMA DISK — YAMAHACHI DENTAL MFG., CO. · 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 9a11266b-0b4a-4cf8-b23d-55efa554e1ca 36 fields · synced May 30, 2026