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

Tray, Surgical, Instrument (FSM) (6) Chisel, Osteotome, Surgical (EMM) (2) ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS (NHA) (1) IMPLANT, ENDOSSEOUS, ROOT-FORM (DZE) (1)

Premarket Exempt

No Yes

Clear

Tatum Surgical-Osteotome Kit - 00083208001116 Catalog Number : Osteotomez Str 24

Device Description : Tatum Universal Straight Osteotome Kit designed for use in bone expansion: Inclu Tatum Universal Straight Osteotome Kit designed for use in bone expansion: Includes 24 instruments and 2 Autoclaveable cassettes:Bone Scalpels (Blue) - BS4.0, 5.0 & 6.0, Bone Blades (Green) - BB5.5, 7.5, & 10.0, "D" Shape (Black) - D1-4.0, D2-5.5, D3-7.5, & D4-10.0, Round Tapered (White) - RT2.0, 3.0, 4.0, & 5.0 Round Parallel Pointed (Yellow) - RP3.0, 3.5, 4.0, 4.5, & 5.0, Round Parallel Blunt (Red) - RB3.0, 3.5, 4.0, 4.5, & 5.0

Device Class : 1

Duns Number: 078352849

Premarket Exempt : Yes

Product Code : EMM

Prescription Use : Yes

Device Count : 1

PST Tray and Lid - 00083208001307 Catalog Number : PST 2701

Device Description : Autoclavable cassette 2.5W x 7.5L : for instruments such as Curette (set of 3), Autoclavable cassette 2.5W x 7.5L : for instruments such as Curette (set of 3), or Micro-Osteotome set

Device Class : 1

Duns Number: 078352849

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Tatum Integrity Implant Kit Box - 00083208001406 Catalog Number : Tatum Integrity Implant Kit Box

Device Description : Tatum Integrity Implant Kit Box (Italy) - Autoclavable Box to hold all Drills, D Tatum Integrity Implant Kit Box (Italy) - Autoclavable Box to hold all Drills, Drivers and ratchet for Integrity Implant placement

Device Class : 1

Duns Number: 078352849

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Tatum "D" Implant Kit Box - 00083208001604 Catalog Number : Tatum "D" Implant Kit Box

Device Description : Tatum "D" Implant Kit Box - #04-3393 - Autoclavable Box to hold all Channel and Tatum "D" Implant Kit Box - #04-3393 - Autoclavable Box to hold all Channel and Socket formers for "D" Implant placement

Device Class : 1

Duns Number: 078352849

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Tatum Tapered Implant Kit Box - 00083208001703 Catalog Number : Tatum Tapered Implant Kit Box

Device Description : Tatum Tapered Implant Kit Box - #04-3389 - Autoclavable Box to hold all Drills, Tatum Tapered Implant Kit Box - #04-3389 - Autoclavable Box to hold all Drills, Drivers and ratchet for Tapered Implant placement

Device Class : 1

Duns Number: 078352849

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

PST Tray and Lid - 00083208001802 Catalog Number : PST 6100A

Device Description : Autoclavable cassette 6W x 10L x 075 deep : for instruments such as periosteal (set of 8)

Device Class : 1

Duns Number: 078352849

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

PST Tray and Lid - 00083208001901 Catalog Number : PST 4711A

Device Description : Autoclavable cassette 4.0W x 7.5L x 1.5Deep: for instruments such as Sinus Flap Autoclavable cassette 4.0W x 7.5L x 1.5Deep: for instruments such as Sinus Flap retractors.

Device Class : 1

Duns Number: 078352849

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Tatum Surgical-Osteotome Kit - 00083208002229 Catalog Number : Osteotomez Offset 24

Device Description : Tatum Universal Offset Osteotome Kit designed for use in bone expansion: Include Tatum Universal Offset Osteotome Kit designed for use in bone expansion: Includes 24 instruments and 2 Autoclaveable cassettes:Bone Scalpels (Blue) - BS4.0, 5.0 & 6.0, Bone Blades (Green) - BB5.5, 7.5, & 10.0, "D" Shape (Black) - D1-4.0, D2-5.5, D3-7.5, & D4-10.0, Round Tapered (White) - RT2.0, 3.0, 4.0, & 5.0 Round Parallel Pointed (Yellow) - RP3.0, 3.5, 4.0, 4.5, & 5.0, Round Parallel Blunt (Red) - RB3.0, 3.5, 4.0, 4.5, & 5.0

Device Class : 1

Duns Number: 078352849

Premarket Exempt : Yes

Product Code : EMM

Prescription Use : Yes

Device Count : 1

TatumSurgical/HC ITI 3.7mm Integrity-Delrin HC for Integrity 3.7mm Implant - 00083208003776 Catalog Number : HC ITI 3.7mm Integrity

Device Description : HC ITI 3.7mm Integrity - Delrin Healing Cap for Integrity 3.7mm Implant

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

TatumSurgical/HC ITI 4.0mm Integrity-Delrin HC for Integrity 4.0mm Implant - 00083208004070 Catalog Number : HC ITI 4.0mm Integrity

Device Description : HC ITI 4.0mm Integrity - Delrin Healing Cap for Integrity 4.0mm Implant

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

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