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) (7) INSTRUMENT, FILLING, PLASTIC, DENTAL (EIY) (3)

Premarket Exempt

No Yes

Clear

AccessPost Overdenture - 00766054000501 Catalog Number : 525-01

Device Description : AccessPost Overdenture Refill Size 1

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

AccessPost Overdenture - 00766054000518 Catalog Number : 525-02

Device Description : AccessPost Overdenture Refill Size 2

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

AccessPost Overdenture - 00766054000525 Catalog Number : 525-03

Device Description : AccessPost Overdenture Refill Size 3

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

AccessPost Overdenture - 00766054000532 Catalog Number : 580-01

Device Description : AccessPost Overdenture Accessories (Caps)

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

AccessPost Overdenture - 00766054000549 Catalog Number : 585-01

Device Description : AccessPost Overdenture Accessories (Studs Size 1)

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

AccessPost Overdenture - 00766054000556 Catalog Number : 585-02

Device Description : AccessPost Overdenture Accessories (Studs Size 2)

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

AccessPost Overdenture - 00766054000563 Catalog Number : 585-03

Device Description : AccessPost Overdenture Accessories (Studs Size 3)

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

AccessPost Overdenture - 00766054000570 Catalog Number : 550-00

Device Description : AccessPost Overdenture EZ-Change Intro

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : EIY

Prescription Use : Yes

Device Count : 1

AccessPost Overdenture - 00766054000587 Catalog Number : 550-01

Device Description : AccessPost Overdenture EZ-Change Refill (Keepers-Caps-Bands)

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : EIY

Prescription Use : Yes

Device Count : 1

AccessPost Overdenture - 00766054000594 Catalog Number : 550-02

Device Description : AccessPost Overdenture EZ-Change Refill (6 Caps)

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : EIY

Prescription Use : Yes

Device Count : 1

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