EXACTA Flow-lc 1-EFBL

GUDID 00815619020215

2g syringe of flowable composite for dental restorations.

EXACTA DENTAL PRODUCTS INC

Dental composite resin
Primary Device ID00815619020215
NIH Device Record Keyf9627e08-9675-41b6-9c70-974241c5b0bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXACTA Flow-lc
Version Model NumberShade BL
Catalog Number1-EFBL
Company DUNS016325552
Company NameEXACTA DENTAL PRODUCTS INC
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
GS100815619020215 [Primary]

FDA Product Code

EBCSealant, Pit And Fissure, And Conditioner

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-19
Device Publish Date2018-10-17

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