ESSENTIAL DENTAL SYSTEMS, INC.

Address:89 LEUNING ST.,S Hackensack,NJ,07606,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

RESIN, ROOT CANAL FILLING (KIF) (7) CLEANSER, ROOT CANAL (KJJ) (2) CEMENT, DENTAL (EMA) (1)

Premarket Exempt

No Yes

Clear

Irritrol - 00766054000105 Catalog Number : 760-16

Device Description : Two-In-One Endodontic Irrigation Liquid for Cleansing a Root Canal

Device Class : U

Duns Number: 101147171

Premarket Exempt : No

Product Code : KJJ

Prescription Use : Yes

Device Count : 1

EDTA Plus - 00766054000112 Catalog Number : 770-02

Device Description : Endodontic Irrigation Liquid for Removal of Smear Layer of Root Canal

Device Class : U

Duns Number: 101147171

Premarket Exempt : No

Product Code : KJJ

Prescription Use : Yes

Device Count : 1

EZ-Fill Root Canal Cement - 00766054000129 Catalog Number : 1600-00

Device Description : Root Canal Cement Powder Jar/Gel Tube with Bi-Directional Spirals Stainless Steel

Device Class : 2

Duns Number: 101147171

Premarket Exempt : No

Product Code : KIF

Prescription Use : Yes

Device Count : 1

EZ-Fill Root Canal Cement - 00766054000136 Catalog Number : 1605-00

Device Description : Root Canal Cement Powder Jar/Gel Tube with Bi-Directional Spirals Nickel Titanium

Device Class : 2

Duns Number: 101147171

Premarket Exempt : No

Product Code : KIF

Prescription Use : Yes

Device Count : 1

EZ-Fill Root Canal Cement - 00766054000143 Catalog Number : 1608-00

Device Description : Root Canal Cement Powder Jar/Gel Tube

Device Class : 2

Duns Number: 101147171

Premarket Exempt : No

Product Code : KIF

Prescription Use : Yes

Device Count : 1

EZ-Fill Epoxy Gel - 00766054000150 Catalog Number : 1610-00

Device Description : Root Canal Gel Tube

Device Class : 2

Duns Number: 101147171

Premarket Exempt : No

Product Code : KIF

Prescription Use : Yes

Device Count : 1

EZ-Fill Xpress - 00766054000167 Catalog Number : 1620-00

Device Description : Root Canal Xpress Cement Syringeable with Bi-Directional Spirals Stainless Steel

Device Class : 2

Duns Number: 101147171

Premarket Exempt : No

Product Code : KIF

Prescription Use : Yes

Device Count : 1

EZ-Fill Xpress - 00766054000174 Catalog Number : 1625-00

Device Description : Root Canal Xpress Cement Syringeable with Bi-Directional Spirals Nickel Titanium

Device Class : 2

Duns Number: 101147171

Premarket Exempt : No

Product Code : KIF

Prescription Use : Yes

Device Count : 1

EZ-Fill Xpress Cement - 00766054000181 Catalog Number : 1628-00

Device Description : Root Canal Xpress Cement Syringeable

Device Class : 2

Duns Number: 101147171

Premarket Exempt : No

Product Code : KIF

Prescription Use : Yes

Device Count : 1

Ti-Core Auto Sample - 00766054000198 Catalog Number : 831-00

Device Description : Core Material Syringeable Dual Cure Natural Shade A2 Sample

Device Class : 2

Duns Number: 101147171

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

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