SEPTODONT SAS SPECIALITES SEPTODONT

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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) Alloy, Amalgam (EJJ) (1) Bone Grafting Material, Synthetic (LYC) (1) Needle, Dental (DZM) (1)

Premarket Exempt

Clear

Ultra Safety Plus Twist kit 25G Long - 03701398105328 Catalog Number :

Device Description : 100 needles 25G long (Red) and 1 handle (to be sterilized)

Device Class : 1

Duns Number: 275273795

Premarket Exempt : No

Product Code : EJI, DZM

Prescription Use : Yes

Device Count : 101

R.T.R. Syringe - 03760140702987 Catalog Number : 01S0500

Device Description : Single-use, sterile resorbable bone substitute

Device Class : 2

Duns Number: 275273795

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

SAFETY PLUS HANDLES - 03760140703151 Catalog Number : 01N3000

Device Description : Sterisable Black Handle for Needle

Device Class : 2

Duns Number: 275273795

Premarket Exempt : No

Product Code : EJI

Prescription Use : Yes

Device Count : 1

ULTRA SAFETY PLUS STER SINGLE USE HANDLE - 03760140703168 Catalog Number : 01N3400

Device Description : Single Use white Sterile handle.

Device Class : 2

Duns Number: 275273795

Premarket Exempt : No

Product Code : EJI

Prescription Use : Yes

Device Count : 1

SAFETY PLUS KIT 25G LONG - 03760140703175 Catalog Number :

Device Description : 100 needles with sterilisable black handle

Device Class : 2

Duns Number: 275273795

Premarket Exempt : No

Product Code : EJI

Prescription Use : Yes

Device Count : 1

SAFETY PLUS KIT 27G SHORT - 03760140703182 Catalog Number : 01N4271

Device Description : 100 needles with sterilisable black handle

Device Class : 2

Duns Number: 275273795

Premarket Exempt : No

Product Code : EJI

Prescription Use : Yes

Device Count : 1

SAFETY PLUS KIT 27G LONG - 03760140703199 Catalog Number : 01N4272

Device Description : 100 needles with sterilisable black handle

Device Class : 2

Duns Number: 275273795

Premarket Exempt : No

Product Code : EJI

Prescription Use : Yes

Device Count : 1

SAFETY PLUS KIT 30G X-SHORT - 03760140703205 Catalog Number : 01N4300

Device Description : 100 needles with sterilisable black handle

Device Class : 2

Duns Number: 275273795

Premarket Exempt : No

Product Code : EJI

Prescription Use : Yes

Device Count : 1

SAFETY PLUS KIT 30G SHORT - 03760140703212 Catalog Number : 01N4301

Device Description : 100 needles with sterilisable black handle

Device Class : 2

Duns Number: 275273795

Premarket Exempt : No

Product Code : EJI

Prescription Use : Yes

Device Count : 1

SEPTALLOY NG50 - 1 SPILL - 03760140703229 Catalog Number : 01C1500

Device Description : Dental amalgam

Device Class : 2

Duns Number: 275273795

Premarket Exempt : No

Product Code : EJJ

Prescription Use : Yes

Device Count : 1

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