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

Tray, Surgical, Instrument (FSM) (5) Accessories, Implant, Dental, Endosseous (NDP) (2) Abutment, Implant, Dental, Endosseous (NHA) (1) Instruments, Dental Hand (DZN) (1) Screw, Fixation, Intraosseous (DZL) (1)

Premarket Exempt

No Yes

Clear

Tatum Surgical Bone Fixation Screw Kit - 00083208000003 Catalog Number : EZ-Bone Fixation Screw Kit

Device Description : Bone Fixation Self-Drilling Screw kit with various size of bone screw for securi

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : DZL

Prescription Use : Yes

Device Count : 1

Tatum Surgical-Tatum Ratchet - 00083208000041 Catalog Number : Tatum Ratchet

Device Description : Tatum Ratchet fits all 3.5mm hex hand tools

Device Class : 1

Duns Number: 078352849

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Tatum Surgical-Osteotome Box ( 6 space) - 00083208000065 Catalog Number : Tatum Surgical-Osteotome Box (6)

Device Description : Tatum Surgical-Osteotome Box - Hold up to 6 instruments - autoclavable

Device Class : 1

Duns Number: 078352849

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Tatum Surgical/IP Healing Plug - 00083208000096 Catalog Number : IP Healing Plug

Device Description : IP Healing Plug 3.0mm Well - material HDPE

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Tatum Surgical-Osteotome Box ( 12 space) - 00083208000126 Catalog Number : Tatum Surgical-Osteotome Box (12)

Device Description : Tatum Surgical-Osteotome Box - Hold up to 12 instruments - autoclavable

Device Class : 1

Duns Number: 078352849

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Tatum Surgical-EZ Screw Driver - 00083208000140 Catalog Number : EZSD

Device Description : Tatum EZ Screw Driver, 2.5mm Hex for bone screws

Device Class : 1

Duns Number: 078352849

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Tatum EZ Out Periotome Kit Box - 00083208000164 Catalog Number : Tatum EZ Out Periotome Kit Box

Device Description : Tatum EZ Out Periotome Kit Box. holds 7 Periotome Instruments

Device Class : 1

Duns Number: 078352849

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Tatum Sinus Instrument Kit Box - 00083208000195 Catalog Number : Tatum Sinus Kit Box

Device Description : Tatum sinus kit Box. holds 10 sinus instruments.

Device Class : 1

Duns Number: 078352849

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Tatum Sinus Retractor Kit Box - 00083208000201 Catalog Number : Tatum Sinus Retractor Kit Box

Device Description : Tatum sinus retractor kit Box. holds 5 Sinus retractors

Device Class : 1

Duns Number: 078352849

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Tatum Surgical-Screw Driver Handle - 00083208000232 Catalog Number : EZ-Screw Fixation Driver Handle

Device Description : Bone Fixation EZ-Screw Driver Handle for Bone Fixation Screw (Kit)

Device Class : 1

Duns Number: 078352849

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : Yes

Device Count : 1

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