PRO Resins Base X

FDA UDI

Class II (US FDA UDI)

by DeltaMed GmbH

Identity

Trade Name: PRO Resins Base X FDA UDI
Generic Name: Dental appliance fabrication material, resin FDA UDI
Device Name: PRO Resins Base X pink-transparent 1000g FDA UDI
Model / Reference: 019.3327 FDA UDI
Description: PRO Resins Base X pink-transparent 1000g FDA UDI

Identifiers

Catalog Number: 019.3327 FDA UDI
Primary DI / UDI-DI: 04260635981358 FDA UDI
510(k) Number: K212541 FDA UDI
FDA Product Code: EBI FDA UDI
GMDN Term: Dental appliance fabrication material, resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3760 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

PRO Resins Base X by DeltaMed GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental appliance fabrication material, resin.

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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

Cleared under the same submission

K212541 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: DeltaMed GmbH

Sources (1)

FDA UDI 1d874b60-919c-4c71-8a24-19eb1c41d4cf 36 fields · synced Jun 8, 2026