SEPTODONT TOOTHFAIRY BPA FREE P&F SEA=

GUDID 00303620000963

SEPTODONT, INC

Dental pit/fissure sealant
Primary Device ID00303620000963
NIH Device Record Keya6fd5bf5-9e2d-41bd-8579-51e22bf03d98
Commercial Distribution StatusIn Commercial Distribution
Brand NameSEPTODONT TOOTHFAIRY BPA FREE P&F SEA=
Version Model Number01C2400
Company DUNS012925513
Company NameSEPTODONT, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Customer Support Contacts

Phone(303) 665-7535
Emailusregulatoryaffairs@septodont.com

Device Dimensions

Weight3.5 Gram

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100303620000963 [Primary]

FDA Product Code

EBCSealant, Pit And Fissure, And Conditioner

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-12

Devices Manufactured by SEPTODONT, INC

13760140703608 - R.T.R Membrane2021-02-08 Absorbable Collagen Membrane (15X20MM) for dental surgery.
03760140703618 - R.T.R Membrane 2021-02-08 Absorbable Collagen Membrane (20X30MM) for dental surgery
13760140703622 - R.T.R Membrane 2021-02-08 Absorbable Collagen Membrane (30X40MM) for dental surgery.
00303620000291 - EARLOOP FACE MASK BLUE 3 PLY (2115)2020-05-06 FACEMASK BLUE E/L
00303620000307 - EARLOOP FACE MASK PINK 3 PLY (2116)2020-05-06 FACEMASK PINK E/L
00303620000314 - EARLOOP FACE MASK WHITE 3 PLY (2130)2020-05-06 MASK E/L WH L1
00303620000109 - 2 INCH CLEAR CONT NYL FILM (0002)2019-11-08 2 INCH CLEAR CONT NYL FILM (0002)
00303620000116 - 3 INCH CLEAR CONT NYLON FILM (0003)2019-11-08 3 INCH CLEAR CONT NYLON FILM (0003)

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