Denplus Inc

Address:333-M Chemin du Tremblay,Boucherville Quebec,CA

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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

Resin, Denture, Relining, Repairing, Rebasing (EBI) (10)

Premarket Exempt

No Yes

Clear

DP-HC - D8451012200 Catalog Number : 1012200

Device Description : LIQUID DP-HC, 1L

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

DP20 - D8451021100 Catalog Number : 1021100

Device Description : DP20, CLR, 454 g

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

DP20 - D8451021200 Catalog Number : 1021200

Device Description : DP20, CLR, 2.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

DP20 - D8451021300 Catalog Number : 1021300

Device Description : DP20, CLR, 11.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

DP20 - D8451021309 Catalog Number : 1021309

Device Description : DP20, CUSTOM, 11.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-20 - D8451031101 Catalog Number : 1031101

Device Description : IMPACT-20, SPL, 454 g

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Impact-20 - D84510311010 Catalog Number : 1031101

Device Description : Impact-20, 1 lbs, SPL

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-20 - D8451031102 Catalog Number : 1031102

Device Description : IMPACT-20, LPL, 454 g

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-20 - D8451031103 Catalog Number : 1031103

Device Description : IMPACT-20, RPI, 454 g

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-20 - D8451031104 Catalog Number : 1031104

Device Description : IMPACT-20, SPI, 454 g

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

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