ACRY PRINT RU-005 Guide

FDA UDI

Class U (US FDA UDI)

by Pro3Dure Medical

Identity

Trade Name: ACRY PRINT RU-005 Guide FDA UDI
Generic Name: Dental appliance fabrication material, resin FDA UDI
Device Name: ACRY PRINT RU-005 Guide 1000g Clear-Transparent FDA UDI
Model / Reference: 1000g ; Clear-Transparent FDA UDI
Description: ACRY PRINT RU-005 Guide 1000g Clear-Transparent FDA UDI

Identifiers

Catalog Number: 0220005 FDA UDI
Primary DI / UDI-DI: EPRC0220005 FDA UDI
510(k) Number: K211415 FDA UDI
FDA Product Code: MQC FDA UDI
GMDN Term: Dental appliance fabrication material, resin FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental appliance fabrication material, resin

ACRY PRINT RU-005 Guide by Pro3Dure Medical — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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 U	Pending data

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Manufacturer

Manufacturer: Pro3Dure Medical

Sources (1)

FDA UDI b5109680-388b-4130-9d3f-95b23056e628 35 fields · synced May 30, 2026