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) (6) Needle, Dental (DZM) (5) Resin, Root Canal Filling (KIF) (4)

Premarket Exempt

Clear

Ultra Safety Plus Twist 25G Long - 03701398101870 Catalog Number : 01N4452

Device Description : 100 needles with one sterilisable handle

Device Class :

Duns Number: 275273795

Premarket Exempt : No

Product Code : DZM, EJI

Prescription Use : Yes

Device Count : 101

Biodentine XP 200 - 03701398102136 Catalog Number : 01C0710

Device Description : Bioactive dentin substitute

Device Class : 2

Duns Number: 275273795

Premarket Exempt : No

Product Code : KIF

Prescription Use : Yes

Device Count : 10

Biodentine XP 500 - 03701398102143 Catalog Number : 01C0720

Device Description : Bioactive dentin substitute

Device Class : 2

Duns Number: 275273795

Premarket Exempt : No

Product Code : KIF

Prescription Use : Yes

Device Count : 10

BioRoot Flow- 2 g - 03701398102556 Catalog Number : 01E0510

Device Description : Bioactive mineral Root Canal Sealer

Device Class : 2

Duns Number: 275273795

Premarket Exempt : No

Product Code : KIF

Prescription Use : Yes

Device Count : 1

BioRoot Flow-0.5 g - 03701398102563 Catalog Number : 01E0500

Device Description : Bioactive mineral Root Canal Sealer

Device Class : 2

Duns Number: 275273795

Premarket Exempt : No

Product Code : KIF

Prescription Use : Yes

Device Count : 1

Ultra Safety Plus Twist Reusable Handle - 03701398103232 Catalog Number :

Device Description : 1 handle to be sterilized

Device Class : 2

Duns Number: 275273795

Premarket Exempt : No

Product Code : EJI

Prescription Use : Yes

Device Count : 1

Ultra Safety Plus Twist kit 30G Extra Short - 03701398105281 Catalog Number :

Device Description : 100 30G Extra Short (Purple) needles 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

Ultra Safety Plus Twist Kit 30G Short - 03701398105298 Catalog Number :

Device Description : 100 needles 30G short (blue) 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

Ultra Safety Plus Twist 27G Short - 03701398105304 Catalog Number :

Device Description : 100 needles 27G short (orange) 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

Ultra Safety Plus Twist kit 27G Long - 03701398105311 Catalog Number :

Device Description : 100 needles 27G long (yellow) 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

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