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

IMPACT-PLUS - D8451011116 Catalog Number : 1011116

Device Description : IMMPACT-PLUS, ORI, 454 g

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-PLUS - D8451011117 Catalog Number : 1011117

Device Description : IMPACT-PLUS, VIR, 454 g

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-PLUS - D8451011201 Catalog Number : 1011201

Device Description : IMPACT-PLUS, SLP, 2.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-PLUS - D8451011202 Catalog Number : 1011202

Device Description : IMPACT-PLUS, LPL, 2.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-PLUS - D8451011203 Catalog Number : 1011203

Device Description : IMPACT-PLUS, RPI, 2.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-PLUS - D8451011204 Catalog Number : 1011204

Device Description : iMPACT-PLUS, SPI.

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-PLUS - D8451011205 Catalog Number : 1011205

Device Description : IMPACT-PLUS, LPI, 2.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-PLUS - D8451011207 Catalog Number : 1011207

Device Description : IMPACT-PLUS, MDP, 2.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-PLUS - D8451011216 Catalog Number : 1011216

Device Description : IMPACT-PLUD, ORI, 2.3kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPACT-PLUS - D8451011217 Catalog Number : 1011217

Device Description : IMPACT-PLUS, VIR, 2.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

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