Suncoast Dental, Inc

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

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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

Screw, Fixation, Intraosseous (DZL) (6) IMPLANT, ENDOSSEOUS, ROOT-FORM (DZE) (3) Instruments, Dental Hand (DZN) (1)

Premarket Exempt

No Yes

Clear

TatumSurgical/HC ITI 4.5mm Integrity-Delrin HC for Integrity 4.5mm Implant - 00083208004575 Catalog Number : HC ITI 4.5mm Integrity

Device Description : HC ITI 4.5mm Integrity - Delrin Healing Cap for Integrity 4.5mm Implant

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

TatumSurgical/HC ITI 5.0mm Integrity-Delrin HC for Integrity 5.0mm Implant - 00083208005077 Catalog Number : HC ITI 5.0mm Integrity

Device Description : HC ITI 5.0mm Integrity - Delrin Healing Cap for Integrity 5.0mm Implant

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Bone Expander Screw Kit - 00083208005558 Catalog Number : Bone Expander Screw Kit (5)

Device Description : Bone Expander Screw Kit (5). Contains 2.6, 3.0, 3.4, 3.8 and 4.3mm Expanders, Ra Bone Expander Screw Kit (5). Contains 2.6, 3.0, 3.4, 3.8 and 4.3mm Expanders, Ratchet Wrench, Ratchet Extender, Latch Grip Adapter, Thumb Wrench, and BoxUsed to create an osteotomy for Implant placement.

Device Class : 1

Duns Number: 078352849

Premarket Exempt : No

Product Code : DZN

Prescription Use : Yes

Device Count : 1

TatumSurgical/HC ITI 6.0mm Integrity-Delrin HC for Integrity 6.0mm Implant - 00083208006074 Catalog Number : HC ITI 6.0mm Integrity

Device Description : HC ITI 6.0mm Integrity - Delrin Healing Cap for Integrity 6.0mm Implant

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Tatum Surgical Bone Fixation Screw - 00083208006135 Catalog Number : Bone Fix Scw 1.5x3mm

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 - 00083208006142 Catalog Number : Bone Fix Scw 1.5x4mm

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 - 00083208006173 Catalog Number : Bone Fix Scw 1.75x8mm

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 - 00083208006180 Catalog Number : Bone Fix Scw 1.75x10mm

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 - 00083208006197 Catalog Number : Bone Fix Scw 1.75x12mm

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 - 00083208006203 Catalog Number : Bone Fix Scw 1.75x14mm

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

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