SEPTODONT, INC

Address:205 Granite Run Dr., Suite 150,Lancaster,PA,17601,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

Syringe, Cartridge (EJI) (8) Injector, Jet, Mechanical-Powered (EGM) (2)

Premarket Exempt

No Yes

Clear

ASPIJECT SELF ASPIRATING SYRINGE - 00303620000000 Catalog Number : 01N2020

Device Description : Dental cartridge syringe

Device Class : 2

Duns Number: 012925513

Premarket Exempt : No

Product Code : EJI

Prescription Use : No

Device Count : 1

ASPIJECT WITH O-RING - 00303620000017 Catalog Number : 01N2030

Device Description : Dental cartridge syringe

Device Class : 2

Duns Number: 012925513

Premarket Exempt : No

Product Code : EJI

Prescription Use : No

Device Count : 1

PAROJECT - 00303620000024 Catalog Number : 01N2040

Device Description : Dental cartridge syringe

Device Class : 2

Duns Number: 012925513

Premarket Exempt : No

Product Code : EGM

Prescription Use : No

Device Count : 1

PLUNGER FOR PAROJECT-HF02500A1 - 00303620000031 Catalog Number :

Device Description : Spare part for dental cartridge syringe

Device Class : 2

Duns Number: 012925513

Premarket Exempt : No

Product Code : EGM

Prescription Use : No

Device Count : 1

SEPTODONT PETITE - BLUE - 00303620000048 Catalog Number : 01N2100

Device Description : Aspirating Syringe Small Blue Septodont USA

Device Class : 2

Duns Number: 012925513

Premarket Exempt : No

Product Code : EJI

Prescription Use : No

Device Count : 1

SEPTODONT FUSION(TITANIUM) SYRINGE - 00303620000055 Catalog Number :

Device Description : Aspirating Syringe Medium Titanium Fusion Septodont USA

Device Class : 2

Duns Number: 012925513

Premarket Exempt : No

Product Code : EJI

Prescription Use : No

Device Count : 1

SEPTODONT STANDARD- GOLD - 00303620000062 Catalog Number : 01N2110

Device Description : Aspirating Syringe Large Gold Septodont USA

Device Class : 2

Duns Number: 012925513

Premarket Exempt : No

Product Code : EJI

Prescription Use : No

Device Count : 1

SEPTODONT PINK PETITE ASPIRATING SYRINGE - 00303620000079 Catalog Number : 01N2120

Device Description : Aspirating Syringe Small Pink Septodont USA

Device Class : 2

Duns Number: 012925513

Premarket Exempt : No

Product Code : EJI

Prescription Use : No

Device Count : 1

SEPTODONT ECO-A ASPIRATING SYR WINGLESS - 00303620000086 Catalog Number : 01N2200

Device Description : Aspirating Syringe Eco-A

Device Class : 2

Duns Number: 012925513

Premarket Exempt : No

Product Code : EJI

Prescription Use : No

Device Count : 1

SEPTODONT ECO-CW ASPIRATING SYR WINGED - 00303620000093 Catalog Number : 01N2210

Device Description : Aspirating Syringe Eco-CW

Device Class : 2

Duns Number: 012925513

Premarket Exempt : No

Product Code : EJI

Prescription Use : No

Device Count : 1

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