dima Print Teeth & Temp

FDA UDI

Class II (US FDA UDI)

by Kulzer, Inc.

Identity

Trade Name: dima Print Teeth & Temp FDA UDI
Generic Name: Dental acrylic resin FDA UDI
Device Name: dima Print Teeth & Temp A3/A3.5 1000g FDA UDI
Model / Reference: 66087426 FDA UDI
Description: dima Print Teeth & Temp A3/A3.5 1000g FDA UDI

Identifiers

Catalog Number: 66087426 FDA UDI
Primary DI / UDI-DI: J014660874260 FDA UDI
510(k) Number: K233868 FDA UDI
FDA Product Code: PZY FDA UDI
EBG FDA UDI
GMDN Term: Dental acrylic resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3590 FDA UDI
872.3770 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

Yes

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental acrylic resin

dima Print Teeth & Temp by Kulzer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K233868 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: Kulzer, Inc.

Sources (1)

FDA UDI 3d0192cd-c01e-4e3a-b393-6f81c805ba36 36 fields · synced May 31, 2026