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3Delta UNlimited

FDA UDI

Class II (US FDA UDI)

by DeltaMed GmbH

Identity

Trade Name
3Delta UNlimited FDA UDI
Generic Name
Dental appliance fabrication material, resin FDA UDI
Device Name
3Delta UNlimited A3 500g FDA UDI
Model / Reference
1613130 FDA UDI
Description
3Delta UNlimited A3 500g FDA UDI

Identifiers

Catalog Number
1613130 FDA UDI
Primary DI / UDI-DI
EDEL16131300 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, resin 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

No

FDA UDI

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

3Delta UNlimited 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 48597390-a785-42d3-8ae9-36c1da8fb202 36 fields · synced May 30, 2026