ProTech SuperBond SBT12

GUDID D814SBT121

120 ml ProTech Thinner

PROTECH PROFESSIONAL PRODUCTS INC

Denture reliner, elastic, short-term
Primary Device IDD814SBT121
NIH Device Record Keya3bee5ff-b5ac-4325-bfc3-85796e25a7c0
Commercial Distribution Discontinuation2016-08-29
Commercial Distribution StatusNot in Commercial Distribution
Brand NameProTech SuperBond
Version Model NumberSBT12
Catalog NumberSBT12
Company DUNS117374900
Company NamePROTECH PROFESSIONAL PRODUCTS 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD814SBT121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-05-20
Device Publish Date2016-08-29

On-Brand Devices [ProTech SuperBond]

D814SRSB115 ml superbond
D814SBT121120 ml ProTech Thinner
D814SBT11160 ml ProTech Thinner
D814SBL121120 ml ProTech Superbond
D814SBL11160 ml ProTech SuperBond
D814SBA121ProTech SuperBond Kit - 120 ml superbond and 120 ml thinner
D814SBA111ProTech SuperBond Kit - 60 ml superbond and 60 ml thinner

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