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

POST, ROOT CANAL (ELR) (9) TRAY, SURGICAL, INSTRUMENT (FSM) (1)

Premarket Exempt

No Yes

Clear

Flexi-Post - 00766054002574 Catalog Number : 197-04

Device Description : Flexi-Post Mini Sterilization Box (Empty)

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Flexi-Post - 00766054002581 Catalog Number : 197-01

Device Description : Flexi-Post Sterilization Box Complete Stainless Steel (50 Posts)

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

Flexi-Post - 00766054002598 Catalog Number : 197-02

Device Description : Flexi-Post Sterilization Box Complete Titanium (50 Posts)

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

Flexi-Post - 00766054002604 Catalog Number : 197-03

Device Description : Flexi-Post Sterilization Box Combi Titanium (Flexi-Post & Flexi OVD)

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

Flexi-Post - 00766054002611 Catalog Number : 197-05

Device Description : Flexi-Post Mini Sterilization Box Complete Stainless Steel (10 Posts)

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

Flexi-Post - 00766054002628 Catalog Number : 197-06

Device Description : Flexi-Post Mini Sterilization Box Complete Titanium (10 Posts)

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

Flexi-Post - 00766054002635 Catalog Number : 197-07

Device Description : Flexi-Post Sterilization Box Combi Stainless Steel (Flexi-Post & Flexi OVD)

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

Flexi-Flange - 00766054002642 Catalog Number : 197-08

Device Description : Flexi-Flange Mini Sterilization Box Complete Stainless Steel (8 Posts)

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

Flexi-Flange - 00766054002659 Catalog Number : 197-09

Device Description : Flexi-Flange Mini Sterilization Box Complete Titanium (8 Posts)

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

EZ-Fit - 00766054002673 Catalog Number : 2535-02

Device Description : EZ-Fit Passive Fiber Post Kit Size 0 Translucent

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

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