TruTemp C&B

GUDID D724N1101161

A3

PEARSON DENTAL SUPPLIES, INC.

Temporary dental crown/bridge resin
Primary Device IDD724N1101161
NIH Device Record Key028338f5-3206-4027-b47f-e1268c0f5e6f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTruTemp C&B
Version Model NumberN110116
Company DUNS082874108
Company NamePEARSON DENTAL SUPPLIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD724N1101161 [Primary]

FDA Product Code

EBGCrown And Bridge, Temporary, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-10-29
Device Publish Date2016-06-23

On-Brand Devices [TruTemp C&B ]

D724N1101181C2
D724N1101161A3
D724N1101141A2
D724N1101121A1

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