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) (4) Mouthguard, Over-The-Counter (OBR) (3) Toothbrush, Manual (EFW) (2) Oral Wound Dressing (OLR) (1)

Premarket Exempt

No Yes

Clear

DENTEK EASY BRUSH STD 10CT IDBR 36 - 00047701001134 Catalog Number :

Device Description : DENTEK EASY BRUSH STD 10CT IDBR 36

Device Class :

Duns Number: 060272465

Premarket Exempt : Yes

Product Code : EFW

Prescription Use : No

Device Count : 10

Dentek - 00047701001202 Catalog Number :

Device Description : DNTK CANKER RELIEF 6CT PATCH 24

Device Class : U

Duns Number: 060272465

Premarket Exempt : No

Product Code : OLR

Prescription Use : No

Device Count : 1

Dentek - 00047701001325 Catalog Number :

Device Description : DNTK FRSH PROTECT 6CT GRD 12

Device Class :

Duns Number: 060272465

Premarket Exempt : No

Product Code : OBR

Prescription Use : No

Device Count : 1

Dentek - 00047701001516 Catalog Number :

Device Description : DNTK CMF FIT 2CT DNTL GRD 12

Device Class : U

Duns Number: 060272465

Premarket Exempt : No

Product Code : OBR

Prescription Use : No

Device Count : 1

DNTK FRSH BREATH 90CT FLS PICK 36 - 00047701001745 Catalog Number :

Device Description : DENTEK FRESH BREATH 90CT FLOSS PICK 36

Device Class :

Duns Number: 060272465

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 90

Dentek - 00047701001752 Catalog Number :

Device Description : DNTK FRSH PROTECT 16CT GRD 12

Device Class : U

Duns Number: 060272465

Premarket Exempt : No

Product Code : OBR

Prescription Use : No

Device Count : 1

DENTEK ADVANCED TRIPLE CLEAN 150CT FLOSS PICK 30 - 00047701001905 Catalog Number :

Device Description : DENTEK ADVANCED TRIPLE CLEAN 150CT FLOSS PICK 30

Device Class :

Duns Number: 060272465

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 150

DENTEK CMF CLEAN 150CT FLOSS PICK 30 - 00047701001950 Catalog Number :

Device Description : DENTEK COMFORT CLEAN 150CT FLOSS PICK 30

Device Class :

Duns Number: 060272465

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 150

DENTEK EASY BRUSH STD 16CT IDBR 36 - 00047701002032 Catalog Number :

Device Description : DENTEK EASY BRUSH STANDARD 16CT IDBR 36

Device Class :

Duns Number: 060272465

Premarket Exempt : Yes

Product Code : EFW

Prescription Use : No

Device Count : 16

DENTEK FUN 75CT FLOSSER 36 - 00047701002100 Catalog Number :

Device Description : DENTEK FUN 75CT FLOSSER 36

Device Class :

Duns Number: 060272465

Premarket Exempt : Yes

Product Code : JES

Prescription Use : No

Device Count : 75

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