Spot-On Etch

GUDID 00348783000832

Spot-On Etch Intro 5 syr 1.2 ml, 20 tips

PREMIER DENTAL PRODUCTS COMPANY

Dental etching solution
Primary Device ID00348783000832
NIH Device Record Keyfe0e075f-cdcc-44d3-94cc-7a0ede745301
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpot-On Etch
Version Model Number3001461
Company DUNS014789663
Company NamePREMIER DENTAL PRODUCTS COMPANY
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100348783000832 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-10-17
Device Publish Date2016-09-21

On-Brand Devices [Spot-On Etch]

00348783000832Spot-On Etch Intro 5 syr 1.2 ml, 20 tips
00348783000825Spot-On Etch Bulk 12 gram syringe, 50 tips

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