UPTEMP By 3D DENTAL

GUDID 00817169021438

UPTEMP TEMPORARY CEMENT AUTOMIX SYRINGE 7 ML NE

3D DENTAL DESIGNS AND DEVELOPMENT, LLC

Zinc polycarboxylate dental cement
Primary Device ID00817169021438
NIH Device Record Keya888e27f-d7eb-402f-8c55-e65df4cc0366
Commercial Distribution StatusIn Commercial Distribution
Brand NameUPTEMP By 3D DENTAL
Version Model NumberTEMNE
Company DUNS080194935
Company Name3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817169021438 [Primary]

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-13
Device Publish Date2026-03-05

On-Brand Devices [UPTEMP By 3D DENTAL]

00817169021445UPTEMP TEMPORARY CEMENT AUTOMIX SYRINGE 7 ML
00817169021438UPTEMP TEMPORARY CEMENT AUTOMIX SYRINGE 7 ML NE

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