Suncoast Dental, Inc

Address:4500 140th Ave N Ste 112,CLEARWATER,FL,33762,US

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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

Screw, Fixation, Intraosseous (DZL) (5) IMPLANT, ENDOSSEOUS, ROOT-FORM (DZE) (2) Instruments, Dental Hand (DZN) (2) Accessories, implant, dental, endosseous (NDP) (1)

Premarket Exempt

No Yes

Clear

Tatum Surgical Bone Fixation Screw - 00083208006210 Catalog Number : Bone Fix Scw 1.5x15mm

Device Description : Bone Fixation Self-Drilling Screw for securing bone blocks

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : DZL

Prescription Use : Yes

Device Count : 1

Tatum Surgical Bone Fixation Screw - 00083208006227 Catalog Number : Bone Fix Scw 1.5x18mm

Device Description : Bone Fixation Self-Drilling Screw for securing bone blocks

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : DZL

Prescription Use : Yes

Device Count : 1

Tatum Surgical Bone Fixation Screw - 00083208006234 Catalog Number : Bone Fix Scw 1.5x21mm

Device Description : Bone Fixation Self-Drilling Screw for securing bone blocks

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : DZL

Prescription Use : Yes

Device Count : 1

Tatum Surgical Bone Fixation Screw - 00083208006241 Catalog Number : Bone Fix Scw 1.5x24mm

Device Description : Bone Fixation Self-Drilling Screw for securing bone blocks

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : DZL

Prescription Use : Yes

Device Count : 1

Tatum Surgical Bone Fixation Screw - 00083208006418 Catalog Number : Bone Fix Scw 2.0x14mm

Device Description : Bone Fixation Self-Drilling Screw for securing bone blocks

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : DZL

Prescription Use : Yes

Device Count : 1

TatumSurgical/HC ITI 7.0mm Integrity-Delrin HC for Integrity 7.0mm Implant - 00083208007071 Catalog Number : HC ITI 7.0mm Integrity

Device Description : HC ITI 7.0mm Integrity - Delrin Healing Cap for Integrity 7.0mm Implant

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Tatum Tunnel Grafting Kit - 00083208007774 Catalog Number : Tunnel Grafting Kit

Device Description : Tatum Tunnel Grafting Kit used to lift/separate (elevate) or tunnel under the p Tatum Tunnel Grafting Kit used to lift/separate (elevate) or tunnel under the periosteum during surgery. Set of 12 Instruments. Nine Molt/Periosteal instrument ( 3 Straight, 3 Left hand and 3 Right hand) and Three retractors to reflect tissue once released.

Device Class : 1

Duns Number: 078352849

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : Yes

Device Count : 1

Zoll Tunnel Graft Kit - 00083208007781 Catalog Number : Tunnel Graft Kit

Device Description : Zoll Tunnel Graft Kit used to lift/separate (elevate) or tunnel under the perios Zoll Tunnel Graft Kit used to lift/separate (elevate) or tunnel under the periosteum during surgery. Set of 12 Instruments. Nine Molt/Periosteal instrument ( 3 Straight, 3 Left hand and 3 Right hand) and Three retractors to reflect tissue once released.

Device Class : 1

Duns Number: 078352849

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : Yes

Device Count : 1

TatumSurgical/HC ITI 8.0mm Integrity-Delrin HC for Integrity 8.0mm Implant - 00083208008078 Catalog Number : HC ITI 8.0mm Integrity

Device Description : HC ITI 8.0mm Integrity - Delrin Healing Cap for Integrity 8.0mm Implant

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

TatumSurgical/Hand Tool - 00083208010040 Catalog Number : HT.01

Device Description : Hand Tool #1 Latch Grip Hand Driver 4mm

Device Class : 1

Duns Number: 078352849

Premarket Exempt : No

Product Code : NDP

Prescription Use : Yes

Device Count : 1

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