RESINCAP LUBE 2300L

GUDID D6502300L0

PATTERN, COPING AND INLAY LUBRICANT

LANG DENTAL MANUFACTURING CO., INC.

Temporary dental crown/bridge resin
Primary Device IDD6502300L0
NIH Device Record Keye63918f1-264e-4e3c-b0fb-a7db4641f519
Commercial Distribution StatusIn Commercial Distribution
Brand NameRESINCAP LUBE
Version Model Number7 GRAM
Catalog Number2300L
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
HIBCCD6502300L0 [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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