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) (8) GAUGE, DEPTH, INSTRUMENT, DENTAL (EIL) (1) TRAY, SURGICAL, INSTRUMENT (FSM) (1)

Premarket Exempt

No Yes

Clear

Flexi-Post - 00766054002475 Catalog Number : 145-01

Device Description : Flexi-Post Economy Refill Size 1 Titanium

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

Flexi-Post - 00766054002482 Catalog Number : 145-02

Device Description : Flexi-Post Economy Refill Size 2 Titanium

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

Flexi-Post - 00766054002499 Catalog Number : 145-03

Device Description : Flexi-Post Economy Refill Size 3 Titanium

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

Flexi-Post - 00766054002505 Catalog Number : 140-00

Device Description : Flexi-Post Economy Refill Size 00 Stainless Steel

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

Flexi-Post - 00766054002512 Catalog Number : 140-0

Device Description : Flexi-Post Economy Refill Size 0 Stainless Steel

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

Flexi-Post - 00766054002529 Catalog Number : 140-01

Device Description : Flexi-Post Economy Refill Size 1 Stainless Steel

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

Flexi-Post - 00766054002536 Catalog Number : 140-02

Device Description : Flexi-Post Economy Refill Size 2 Stainless Steel

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

Flexi-Post - 00766054002543 Catalog Number : 140-03

Device Description : Flexi-Post Economy Refill Size 3 Stainless Steel

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

Flexi-Post - 00766054002550 Catalog Number : 195-00

Device Description : Flexi-Post Depth Gauge

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : EIL

Prescription Use : Yes

Device Count : 1

Flexi-Post - 00766054002567 Catalog Number : 197-00

Device Description : Flexi-Post Sterilization Box (Empty)

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

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