Philips Zoom!

GUDID 08710103632061

Discus Dental, LLC

Dental coating, tooth-desensitizing
Primary Device ID08710103632061
NIH Device Record Key2abcbfdf-6846-4c2b-8368-dc687081113f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhilips Zoom!
Version Model NumberDIS5714/01
Company DUNS831726109
Company NameDiscus Dental, LLC
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
GS108710103632061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LBHVARNISH, CAVITY

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-01
Device Publish Date2019-06-21

On-Brand Devices [Philips Zoom!]

00075020035004DIS557/01
00075020034991DIS556/01
08710103632061DIS5714/01

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