3D Dental - Dream

GUDID 00817169020172

DREAM FLUORIDE VARNISH BUBBLE GUM .40 ML BOX/50

3D DENTAL DESIGNS AND DEVELOPMENT, LLC

Dental coating, tooth-desensitizing
Primary Device ID00817169020172
NIH Device Record Key378adf7c-ad9d-4ae7-a699-671c89ba2ede
Commercial Distribution StatusIn Commercial Distribution
Brand Name3D Dental - Dream
Version Model NumberDFVBG
Company DUNS080194935
Company Name3D DENTAL DESIGNS AND DEVELOPMENT, 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 Usefalse
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
GS100817169020172 [Primary]
GS110817169020179 [Package]
Package: Case/12 [600 Units]
In Commercial Distribution

FDA Product Code

LBHVarnish, Cavity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-02-07
Device Publish Date2016-12-12

On-Brand Devices [3D Dental - Dream]

00817169020189DREAM FLUORIDE VARNISH SPEARMINT .40 ML BOX/50
00817169020172DREAM FLUORIDE VARNISH BUBBLE GUM .40 ML BOX/50
00817169021483DREAM FLUORIDE VARNISH MELON..40 ML BOX/50

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