MEDTECH PRODUCTS INC.

Address:660 white plains rd,Tarrytown,NY,10591,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

Floss, Dental (JES) (6) Toothbrush, Manual (EFW) (3) Mouthguard, Over-The-Counter (OBR) (1)

Premarket Exempt

No Yes

Clear

DENTEK CMPLT CLEAN BK 75CT FLS PICK 72 - 00047701002155 Catalog Number :

Device Description : DENTEK COMPLETE CLEAN BACK 75CT FLOSS PICK 72

Device Class : 1

Duns Number: 060272465

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 75

DENTEK SLIM BRUSH 32CT IDBR 36 - 00047701002247 Catalog Number :

Device Description : DENTEK SLIM BRUSH 32CT IDBR 36

Device Class :

Duns Number: 060272465

Premarket Exempt : Yes

Product Code : EFW

Prescription Use : No

Device Count : 32

DENTEK DEEP CLEAN 100CT IDBR 24 - 00047701002407 Catalog Number :

Device Description : DENTEK DEEP CLEAN 100CT IDBR 24

Device Class :

Duns Number: 060272465

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 100

DENTEK FUN 40CT FLOSSER 72 - 00047701002568 Catalog Number :

Device Description : DENTEK FUN 40CT FLOSSER 72

Device Class :

Duns Number: 060272465

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 40

DENTEK EASY BRUSH 16CT WIDE 36 - 00047701002582 Catalog Number :

Device Description : DENTEK EASY BRUSH 16CT WIDE 36

Device Class :

Duns Number: 060272465

Premarket Exempt : Yes

Product Code : EFW

Prescription Use : No

Device Count : 16

DENTEK ADV ANCED TRIPLE CLEAN 75CT FLS PICK 72 - 00047701002704 Catalog Number :

Device Description : DENTEK ADVANCED TRIPLE CLEAN 75CT FLS PICK 72

Device Class :

Duns Number: 060272465

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 75

DENTEK CMF CLEAN 75CT FLOSS PICK 24 - 00047701002711 Catalog Number :

Device Description : DENTEK COMFORT CLEAN 75CT FLOSS PICK 24

Device Class : 1

Duns Number: 060272465

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 75

Dentek - 00047701002773 Catalog Number :

Device Description : DNTK MAX PROTECT DNTL GRD 12

Device Class : U

Duns Number: 060272465

Premarket Exempt : No

Product Code : OBR

Prescription Use : No

Device Count : 1

DENTEK EASY BRUSH TIGHT 16CT IDBR 36 - 00047701002834 Catalog Number :

Device Description : DENTEK EASY BRUSH TIGHT 16CT IDBR 36

Device Class :

Duns Number: 060272465

Premarket Exempt : Yes

Product Code : EFW

Prescription Use : No

Device Count : 16

DENTEK ON THE GO 4CT FLOSS PICK DS 36 - 00047701003466 Catalog Number :

Device Description : DENTEK ON THE GO 4CT FLOSS PICK DS 36

Device Class :

Duns Number: 060272465

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 4

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