Porcelain Etch

GUDID 07290115050479

B.J.M. LABORATORIES LTD

Dental prosthesis priming agent
Primary Device ID07290115050479
NIH Device Record Keya13bb972-3692-49a5-ac8e-a2aa7398a1cf
Commercial Distribution StatusIn Commercial Distribution
Brand NamePorcelain Etch
Version Model Number400082
Company DUNS514764117
Company NameB.J.M. LABORATORIES LTD
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 Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Total Volume2.4 Milliliter
Total Volume2.4 Milliliter
Total Volume2.4 Milliliter
Total Volume2.4 Milliliter
Total Volume2.4 Milliliter
Total Volume2.4 Milliliter
Total Volume2.4 Milliliter
Total Volume2.4 Milliliter
Total Volume2.4 Milliliter
Total Volume2.4 Milliliter
Total Volume2.4 Milliliter
Total Volume2.4 Milliliter
Total Volume2.4 Milliliter
Total Volume2.4 Milliliter
Total Volume2.4 Milliliter
Total Volume2.4 Milliliter
Total Volume2.4 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 and 24 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290115050479 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLEAGENT, TOOTH BONDING, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-30
Device Publish Date2023-11-22

Devices Manufactured by B.J.M. LABORATORIES LTD

07290115050141 - Multi Bond2023-11-30
07290115050158 - Multi Bond2023-11-30
07290115050370 - High-Q-Bond Adhesive Resin Cement Automix2023-11-30
07290115050448 - Porcelain Fix2023-11-30 Single package containing 2 syringes Porcelain Etch and 2 bottles Porcelain Silane
07290115050462 - Porcelain Silane2023-11-30
07290115050479 - Porcelain Etch2023-11-30
07290115050479 - Porcelain Etch2023-11-30
07290115052886 - Auto-Cure Activator2023-11-30

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