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

DP97 - D8451001303 Catalog Number : 1001303

Device Description : DP97, RPI, 11.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

DP97 - D8451001307 Catalog Number : 1001307

Device Description : DP97, MDP, 11.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

DP97 - D8451001309 Catalog Number : 1001309

Device Description : DP97, Custom, 11.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

DP97 - D8451001316 Catalog Number : 1001316

Device Description : DP97, ORI, 11.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-PLUS - D8451011101 Catalog Number : 1011101

Device Description : IMPACT-PLUS, SLP, 454 g

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-PLUS - D8451011102 Catalog Number : 1011102

Device Description : IMPACT-PLUS, LPL, 454 g

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-PLUS - D8451011103 Catalog Number : 1011103

Device Description : IMPACT-PLUS, RPI, 454 g

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-PLUS - D8451011104 Catalog Number : 1011104

Device Description : IMPACT-PLUS, SPI, 454 g

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-PLUS - D8451011105 Catalog Number : 1011105

Device Description : IMPACT-PLUS, LPI, 454 g

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-PLUS - D8451011107 Catalog Number : 1011107

Device Description : IMPACT-PLUS, MDP,454 g

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

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