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

Yes No

Clear

IMPACT-PLUS - D8451011301 Catalog Number : 1011301

Device Description : IMPACT-PLUS, SPL, 11.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-PLUS - D8451011302 Catalog Number : 1011302

Device Description : IMPACT-PLUS,LPL, 11.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-PLUS - D8451011303 Catalog Number : 1011303

Device Description : IMPACT-PLUS, RPI, 11.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-PLUS - D8451011304 Catalog Number : 1011304

Device Description : IMPACT-PLUS, SPI, 11.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-PLUS - D8451011305 Catalog Number : 1011305

Device Description : IMPACT-PLUS, LPI, 11.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-PLUS - D8451011307 Catalog Number : 1011307

Device Description : IMPACT-PLUS, MDP, 11.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-PLUS - D8451011309 Catalog Number : 1011309

Device Description : IMPACT-PLUS, CUSTOM, 11.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-PLUS - D8451011316 Catalog Number : 1011316

Device Description : IMPACT-PLUS, ORI, 11.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-PLUS - D8451011317 Catalog Number : 1011317

Device Description : IMPACT-PLUS, VIR, 11.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

DP-HC - D8451012100 Catalog Number : 1012100

Device Description : LIQUID DP-HC, 250 ml

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

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