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) (4) Wax, Dental, Intraoral (EGD) (4) Material, Impression Tray, Resin (EBH) (2)

Premarket Exempt

No Yes

Clear

POUR-PLUS - D8451151307 Catalog Number : 1151307

Device Description : POUR-PLUS, MDP, 11.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

POUR-PLUS - D8451151316 Catalog Number : 1151316

Device Description : POUR-PLUS, ORI, 11.3 kg

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

POUR-PLUS - D8451152100 Catalog Number : 1152100

Device Description : POUR-PLUS LIQUID, 250 ml

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

POUR-PLUS - D8451152200 Catalog Number : 1152200

Device Description : POUR-PLUS LIQUID, 500 ml

Device Class : 2

Duns Number: 202016064

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

BasePlate Wax - D8453001101 Catalog Number : 3001101

Device Description : Base Plate Wax, Pink, 2.3 kg

Device Class : 1

Duns Number: 202016064

Premarket Exempt : Yes

Product Code : EGD

Prescription Use : No

Device Count : 1

BasePlate Wax - D8453001102 Catalog Number : 3001102

Device Description : Base Plate Wax, Red, 2.3 kg

Device Class : 1

Duns Number: 202016064

Premarket Exempt : Yes

Product Code : EGD

Prescription Use : No

Device Count : 1

Bite Occlusion Rims - Wax - D8453003101 Catalog Number : 3003101

Device Description : Bite Occlusion Rims - Wax, Pink, 100 units

Device Class : 1

Duns Number: 202016064

Premarket Exempt : Yes

Product Code : EGD

Prescription Use : No

Device Count : 1

Laminated Bite Wafers-Wax - D8453003102 Catalog Number : 3003102

Device Description : Laminated Bite Wafers-Wax, White, 35 units

Device Class : 1

Duns Number: 202016064

Premarket Exempt : Yes

Product Code : EGD

Prescription Use : No

Device Count : 1

Photo-Base - D8453051101 Catalog Number : 3051101

Device Description : Light curing preformed sheets, Pink, 50 sheets

Device Class : 1

Duns Number: 202016064

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : No

Device Count : 1

Photo-Tray - D8453051102 Catalog Number : 3051102

Device Description : Light curing preformed sheets, Blue, 50 sheets

Device Class : 1

Duns Number: 202016064

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : No

Device Count : 1

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