ISOTEK, MDC Dental

FDA UDI

Class I (US FDA UDI)

by Mdc Dental

Identity

Trade Name: ISOTEK, MDC Dental FDA UDI
Generic Name: Resin artificial teeth FDA UDI
Device Name: Box with 30 tablets of acrylic resin tooth Anterior FDA UDI
Model / Reference: Anterior FDA UDI
Description: Box with 30 tablets of acrylic resin tooth Anterior FDA UDI

Identifiers

Primary DI / UDI-DI: 07506338322416 FDA UDI
FDA Product Code: ELK FDA UDI
GMDN Term: Resin artificial teeth FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3910 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

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Resin artificial teeth

ISOTEK, MDC Dental by Mdc Dental — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Mdc Dental

Sources (1)

FDA UDI d32ea52d-66f5-4907-a136-e5935e6a026c 34 fields · synced Jun 6, 2026