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) (8) HANDLE, INSTRUMENT, DENTAL (EJB) (1) Handpiece, contra- and right-angle attachment, dental (EGS) (1)

Premarket Exempt

No Yes

Clear

AccessPost Overdenture - 00766054000600 Catalog Number : 550-03

Device Description : AccessPost Overdenture EZ-Change Wrench

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : EJB

Prescription Use : Yes

Device Count : 1

Tango-Endo - 00766054000617 Catalog Number : 5425-00

Device Description : Tango-Endo Intro Kit 25mm

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : EKP

Prescription Use : Yes

Device Count : 1

Tango-Endo - 00766054000624 Catalog Number : 5421-00

Device Description : Tango-Endo Intro Kit 21mm

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : EKP

Prescription Use : Yes

Device Count : 1

Tango-Endo - 00766054000631 Catalog Number : 5421-02

Device Description : Tango-Endo Refill Shaping 21mm

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : EKP

Prescription Use : Yes

Device Count : 1

Tango-Endo - 00766054000648 Catalog Number : 5425-02

Device Description : Tango-Endo Refill Shaping 25 mm

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : EKP

Prescription Use : Yes

Device Count : 1

Tango-Endo - 00766054000655 Catalog Number : 5421-04

Device Description : Tango-Endo Refill Finishing 21 mm

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : EKP

Prescription Use : Yes

Device Count : 1

Tango-Endo - 00766054000662 Catalog Number : 5425-04

Device Description : Tango-Endo Refill Finishing 25 mm

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : EKP

Prescription Use : Yes

Device Count : 1

Tango-Endo - 00766054000679 Catalog Number : 5425-40

Device Description : Tango-Endo Refill Large Canals 25 mm

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : EKP

Prescription Use : Yes

Device Count : 1

Tango-Endo - 00766054000686 Catalog Number : 5425-50

Device Description : Tango-Endo Refill Extra Large Canals 25 mm

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : EKP

Prescription Use : Yes

Device Count : 1

Tango-Endo - 00766054000693 Catalog Number : 5300-00

Device Description : Tango-Endo Reciprocating Handpiece - Latch Type

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : EGS

Prescription Use : Yes

Device Count : 1

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