Pro3dure Gr-19 Oa

FDA UDI

Class U (US FDA UDI)

by Pro3Dure Medical

Identity

Trade Name: PRO3DURE GR-19 OA FDA UDI
Generic Name: Dental appliance fabrication material, resin FDA UDI
Device Name: printodent GR-19 OA FDA UDI
Model / Reference: 500 g - Rose transparent FDA UDI
Description: printodent GR-19 OA FDA UDI

Identifiers

Catalog Number: D1001611 FDA UDI
Primary DI / UDI-DI: EPRCD1001611 FDA UDI
510(k) Number: K211415 FDA UDI
FDA Product Code: MQC FDA UDI
EBI FDA UDI
KMY FDA UDI
GMDN Term: Dental appliance fabrication material, resin FDA UDI

Classification

Device Class: U FDA UDI
Regulation Number: 872.3760 FDA UDI
872.5525 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

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

Pro3dure Gr-19 Oa by Pro3Dure Medical — Class U — 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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BASIS HI — YAMAHACHI DENTAL MFG., CO. · Class II
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HI-I® — FRICKE INTERNATIONAL, INC. · Class II
FREEPRINT crown A1 500g — DETAX GmbH · Class II

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 0da53ab6-5ef1-4185-86b5-538f03e89fa3 37 fields · synced May 30, 2026