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

Accessories, Implant, Dental, Endosseous (NDP) (4) IMPLANT, ENDOSSEOUS, ROOT-FORM (DZE) (4) Abutment, Implant, Dental, Endosseous (NHA) (2)

Premarket Exempt

No Yes

Clear

Tatum Surgical ITI Integrity Ball Screw - 00083208920011 Catalog Number : PITI-2.0 Ball Screw

Device Description : Integrity 2.0mm ball screw for taking impressions with 3.7-5.0mm Implant components.

Device Class : 1

Duns Number: 078352849

Premarket Exempt : No

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Tatum Surgical Integrity - 00083208920028 Catalog Number : Analog ITI-OT XFer Screw 2.0

Device Description : Integrity Open Tray Transfer Screw 2.0mm, Fits transfers 3.7-4.5 & 5.0mm

Device Class : 1

Duns Number: 078352849

Premarket Exempt : No

Product Code : NDP

Prescription Use : Yes

Device Count : 1

TatumSurgical/Integrity 2.5mm Abutment RH Screw for 6.0-8.0mm Implants - 00083208925009 Catalog Number : PITI-2.5 AS

Device Description : Integrity 2.5mm Abutment RH Screw for 6.0-8.0mm Implants

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Tatum Surgical ITI Integrity Ball Screw - 00083208925016 Catalog Number : PITI-2.5 Ball Screw

Device Description : Integrity 2.5mm ball screw for taking impressions with 6.0-8.0mm Implant components.

Device Class : 1

Duns Number: 078352849

Premarket Exempt : No

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Tatum Surgical Integrity - 00083208925023 Catalog Number : Analog ITI-OT XFer Screw 2.5

Device Description : Integrity Open Tray Transfer Screw 2.5mm, Fits transfers 6.0-8.0mm

Device Class : 1

Duns Number: 078352849

Premarket Exempt : No

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Tatum Surgical-Integrity One Piece Abutment 3.7-4.5 - 00083208934452 Catalog Number : PITI-OP 3.7-4.5 (0°)

Device Description : Integrity One Piece, Threaded Abutment for 3.7-4.5mm implants

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

TatumSurgical/Abutment (Integrity Post) - 00083208937002 Catalog Number : PITI-37.00

Device Description : Integrity Implant Abutment 3.7mm x 0 degree -7mm Height

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

TatumSurgical/Abutment (Integrity Post) - 00083208937156 Catalog Number : PITI-37.15

Device Description : Integrity Implant Abutment 3.7mm x 15 degree -7mm Height

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

TatumSurgical/Abutment (Integrity Post) - 00083208937309 Catalog Number : PITI-37.30

Device Description : Integrity Implant Abutment 3.7mm x 30 degree -7mm Height

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Tatum Surgical/Abutment (Post) - 00083208937453 Catalog Number : PITI3.7-4.5 Blank

Device Description : Abutment/3.7 to 4.5 Blank straight post for Integrity 3.7-4.5 Implants

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

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