JET SET-4 TOOTH SHADW POWDER 382066M

GUDID D650382066M0

VERY FAST CURING PROVISIONAL CROWN & BRIDE ACRYLIC RESIN POWDER

LANG DENTAL MANUFACTURING CO., INC.

Temporary dental crown/bridge resin
Primary Device IDD650382066M0
NIH Device Record Key5bf88585-e9de-452f-957e-250c8fad6d35
Commercial Distribution StatusIn Commercial Distribution
Brand NameJET SET-4 TOOTH SHADW POWDER
Version Model Number100 GRAM SHADE 66/A3
Catalog Number382066M
Company DUNS005185798
Company NameLANG DENTAL MANUFACTURING CO., INC.
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 Usetrue
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
HIBCCD650382066M0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number4
Public Version Date2021-10-29
Device Publish Date2016-09-01

Devices Manufactured by LANG DENTAL MANUFACTURING CO., INC.

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D6501356PT0 - ORTHO-JET2023-07-05 FAST CURING ORTHODONTIC ACRYLIC RESIN POWDER AND LIQUID
D6501480LI0 - JET TOOTH SHADE POWDER2023-07-05 FAST CURING PROVISIONAL CROWN & BRIDGE ACRYLIC RESIN
D6504720F20 - JET SET-4 DENTURE REPAIR2022-10-28 VERY FAST CURING DENTURE REPAIR ACRYLIC RESIN POWDER

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