Prima Quick Prime

GUDID 07290115050196

B.J.M. LABORATORIES LTD

Dentine bonding agent/set
Primary Device ID07290115050196
NIH Device Record Key20920f92-6c57-4204-a9ab-e8b12e0f435e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrima Quick Prime
Version Model Number100210
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 Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290115050196 [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 Date2026-03-23
Device Publish Date2026-03-13

Devices Manufactured by B.J.M. LABORATORIES LTD

07290115050400 - High-Q-Bond SE2026-03-30
07290115050523 - BJM Root Canal Sealer2026-03-30
07290115050035 - High-Q-Bond Bracket Adhesive2026-03-23
07290115050196 - Prima Quick Prime2026-03-23
07290115050196 - Prima Quick Prime2026-03-23
07290115053340 - Quick Seal2026-03-23
07290115051889 - Smile Stream STEP-1 PumEtch2026-03-23
07290115051896 - Ideal 1 Orthodontic Bracket Adhesive2026-03-23
07290115051902 - High-Q-Bond Band2026-03-23

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