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

REAMER, PULP CANAL, ENDODONTIC (EKP) (4) Handpiece, direct drive, ac-powered (EKX) (3) POST, ROOT CANAL (ELR) (3)

Premarket Exempt

No Yes

Clear

EZ-Fit - 00766054002680 Catalog Number : 2535-01

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

EZ-Fit - 00766054002697 Catalog Number : 2535-0

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

AccessPost Overdenture - 00766054002703 Catalog Number : 527-01

Device Description : AccessPost Overdenture Trial Kit Size 1

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

Endo CSV - 00766054002710 Catalog Number : 5100-00

Device Description : Endo CSV Hand Piece

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : EKX

Prescription Use : Yes

Device Count : 1

Endo CSV - 00766054002727 Catalog Number : 5121-00

Device Description : Endo CSV Hand Piece with 21 mm Instruments

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : EKX

Prescription Use : Yes

Device Count : 1

Endo CSV - 00766054002734 Catalog Number : 5125-00

Device Description : Endo CSV Hand Piece with 25 mm Instruments

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : EKX

Prescription Use : Yes

Device Count : 1

Safesider HF - 00766054002741 Catalog Number : 5121-123

Device Description : Safesider HF Intro Kit 21 mm

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : EKP

Prescription Use : Yes

Device Count : 1

Safesider HF - 00766054002758 Catalog Number : 5125-123

Device Description : Safesider HF Intro Kit 25 mm

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : EKP

Prescription Use : Yes

Device Count : 1

Safesider HF - 00766054002765 Catalog Number : 5121-01

Device Description : Safesider HF Glidepath Refill 21 mm

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : EKP

Prescription Use : Yes

Device Count : 1

Safesider HF - 00766054002772 Catalog Number : 5121-02

Device Description : Safesider HF Shaper Refill 21 mm

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : EKP

Prescription Use : Yes

Device Count : 1

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