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PRO Resins Arch X

FDA UDI

Class II (US FDA UDI)

by DeltaMed GmbH

Identity

Trade Name
PRO Resins Arch X FDA UDI
Generic Name
Dental appliance fabrication material, combination-material FDA UDI
Device Name
PRO Resins Arch X A1 1000g FDA UDI
Model / Reference
019.3256 FDA UDI
Description
PRO Resins Arch X A1 1000g FDA UDI

Identifiers

Catalog Number
019.3256 FDA UDI
Primary DI / UDI-DI
04260635981488 FDA UDI
510(k) Number
K243720 FDA UDI
FDA Product Code
EBF FDA UDI
EBI FDA UDI
EBG FDA UDI
PZY FDA UDI
GMDN Term
Dental appliance fabrication material, combination-material FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3690 FDA UDI
872.3760 FDA UDI
872.3770 FDA UDI
872.3590 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Resin artificial teethDental appliance fabrication material, resinTemporary dental crown/bridge resinDental appliance fabrication material, combination-material

PRO Resins Arch 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, combination-material.

Cleared under the same submission

K243720 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DeltaMed GmbH

Sources (1)

  • FDA UDI b5e37f3d-0a33-4933-9282-e67a7e18999a 36 fields · synced May 30, 2026