Smart Dent ®

FDA UDI

Class I (US FDA UDI)

by Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.

Identity

Trade Name: Smart Dent ® FDA UDI
Generic Name: Dental appliance fabrication material, resin FDA UDI
Device Name: 3D Printing Resin for models FDA UDI
Model / Reference: SMART PRINT L'AQUA MODEL 500g FDA UDI
Description: 3D Printing Resin for models FDA UDI

Identifiers

Primary DI / UDI-DI: D14307560147451530 FDA UDI
FDA Product Code: EBH FDA UDI
GMDN Term: Dental appliance fabrication material, resin FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3670 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental appliance fabrication material, resin

Smart Dent ® by Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dental appliance fabrication material, resin.

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Axcent Acrylics — GARRECO, LLC · Class II
smartrepair A2 — DETAX GmbH & Co. KG · Class IIa
BASIS HI — YAMAHACHI DENTAL MFG., CO. · Class II
vynacron dental resins — VYNACRON DENTAL RESINS, INC. · Class II
HI-I® — FRICKE INTERNATIONAL, INC. · Class II
FREEPRINT crown A1 500g — DETAX GmbH · Class II

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: Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.

Sources (1)

FDA UDI a763eaaf-ec76-45f4-8f2e-a41706615e98 33 fields · synced May 30, 2026