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

Wrap, Sterilization (FRG) (6) Mask, Surgical (FXX) (3) Material, Tooth Shade, Resin (EBF) (1)

Premarket Exempt

No Yes

Clear

4 INCH LOGO PERF NYLON FILM (0024) - 00303620000208 Catalog Number : 01I0024

Device Description : 4 INCH LOGO PERF NYLON FILM (0024)

Device Class : 2

Duns Number: 012925513

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 1

6 INCH LOGO PERF NYLON FILM (0026) - 00303620000215 Catalog Number : 01I0032

Device Description : 6 INCH LOGO PERF NYLON FILM (0026)

Device Class : 2

Duns Number: 012925513

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 1

2 INCH SELF SEAL POUCH (0032) - 00303620000222 Catalog Number : 01I0032

Device Description : 2 INCH SELF SEAL POUCH (0032)

Device Class : 2

Duns Number: 012925513

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 1

3 INCH SELF SEAL POUCH (0033) - 00303620000239 Catalog Number :

Device Description : 3 INCH SELF SEAL POUCH (0033)

Device Class : 2

Duns Number: 012925513

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 1

4 INCH SELF SEAL POUCH (0034) - 00303620000246 Catalog Number : 01I0034

Device Description : 4 INCH SELF SEAL POUCH (0034)

Device Class : 2

Duns Number: 012925513

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 1

6 INCH SELF SEAL POUCH (0036) - 00303620000253 Catalog Number :

Device Description : 6 INCH SELF SEAL POUCH (0036)

Device Class : 2

Duns Number: 012925513

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 1

EARLOOP FACE MASK BLUE 3 PLY (2115) - 00303620000291 Catalog Number :

Device Description : FACEMASK BLUE E/L

Device Class : 2

Duns Number: 012925513

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

EARLOOP FACE MASK PINK 3 PLY (2116) - 00303620000307 Catalog Number :

Device Description : FACEMASK PINK E/L

Device Class : 2

Duns Number: 012925513

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

EARLOOP FACE MASK WHITE 3 PLY (2130) - 00303620000314 Catalog Number :

Device Description : MASK E/L WH L1

Device Class : 2

Duns Number: 012925513

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

Adherence - 00303620000505 Catalog Number :

Device Description : Adherence Dual Cure Resin Cement Kit

Device Class : 2

Duns Number: 012925513

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

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