INTEGRATED DENTAL SYSTEMS, LLC

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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

Implant, Endosseous, Root-Form (DZE) (10)

Premarket Exempt

Clear

Reflect Implant System - 00817773025426 Catalog Number : RCHA3383C

Device Description : Reflect™ Certus 3.4 Healing Abutment Ø3.4 x 3H

Device Class : 2

Duns Number: 079439145

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Reflect Implant System - 00817773025433 Catalog Number : RCHA3382C

Device Description : Reflect™ Certus 3.4 Healing Abutment Ø3.4 x 2H

Device Class : 2

Duns Number: 079439145

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Reflect Implant System - 00817773025440 Catalog Number : RCICC50S

Device Description : Reflect Certus Closed-Tray Tran 5.0 x 5.0D x 10H

Device Class : 2

Duns Number: 079439145

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Reflect Implant System - 00817773025457 Catalog Number : RCICC41S

Device Description : Reflect Certus Closed-Tray Tran 4.1 x 4.1D x 10H

Device Class : 2

Duns Number: 079439145

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Reflect Implant System - 00817773025464 Catalog Number : RCICC34S

Device Description : Reflect Certus Closed-Tray Tran 3.4 x 3.4D x 10H

Device Class : 2

Duns Number: 079439145

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Reflect Implant System - 00817773025471 Catalog Number : RCHA4503C

Device Description : Reflect Certus 4.1 Healing

Device Class : 2

Duns Number: 079439145

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Reflect Implant System - 00817773025488 Catalog Number : RCHA4504C

Device Description : Reflect Certus 4.1 Healing

Device Class : 2

Duns Number: 079439145

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Reflect Implant System - 00817773025495 Catalog Number : RCICO50S

Device Description : Reflect Certus Open-Tray

Device Class : 2

Duns Number: 079439145

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

CemPlant - 00817773026096 Catalog Number : CP400

Device Description : CemPlant Implant Cement

Device Class : 2

Duns Number: 079439145

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Reflect Implant System - 00817773026201 Catalog Number :

Device Description : Reflect Certus 4.1 Healing Abut 6.0x4H

Device Class : 2

Duns Number: 079439145

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

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