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

Abutment, Implant, Dental, Endosseous (NHA) (6) IMPLANT, ENDOSSEOUS, ROOT-FORM (DZE) (4)

Premarket Exempt

No Yes

Clear

Tatum Surgical/Abutment (Post) - 00083208860508 Catalog Number : PN60.50S

Device Description : Abutment/6.0mm x 50 degree Post Short

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Tatum Surgical/Abutment (Post) - 00083208860607 Catalog Number : PN60.60S

Device Description : Abutment/6.0mm x 60 degree Post Short

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

TatumSurgical/Abutment (Post) - 00083208870002 Catalog Number : PN70.00S

Device Description : Implant Abutment 7.0mm x 0 degree(Straight)-5mm Height

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Tatum Surgical/Abutment (Post) - 00083208880001 Catalog Number : PN80.00S

Device Description : Abutment/8.0mm x 0 degree Post Short

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Tatum Surgical/Abutment (Post) - 00083208900501 Catalog Number : PITI5.0 Blank

Device Description : Abutment/5.0 Blank straight post for Integrity 5.0 Implants

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Tatum Surgical Integrity Abutment - 00083208903458 Catalog Number : PITI-3.7 - 4.5 (0°)

Device Description : Integrity Implant Abutment 3.7 - 4.5mm x 0° (Straight) -7mm Height. To fit Integ Integrity Implant Abutment 3.7 - 4.5mm x 0° (Straight) -7mm Height. To fit Integrity Implants diameter sizes 3.7 to 4.5 mm.

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Tatum Surgical Integrity Abutment - 00083208906787 Catalog Number : PITI-6.0-8.0 (0°)

Device Description : Integrity Implant Abutment 6.0 - 8.0mm x 0° (Straight) -7mm Height. To fit Integ Integrity Implant Abutment 6.0 - 8.0mm x 0° (Straight) -7mm Height. To fit Integrity Implants diameter sizes 6.0 to 8.0mm.

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Tatum Surgical Integrity Abutment - 00083208915345 Catalog Number : PITI-3.7 - 4.5 (15°)

Device Description : Integrity Implant Abutment 3.7 - 4.5mm x 15° angled -7mm Height. To fit Integrit Integrity Implant Abutment 3.7 - 4.5mm x 15° angled -7mm Height. To fit Integrity Implants diameter sizes 3.7 to 4.5 mm.

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Tatum Surgical Integrity Abutment - 00083208915680 Catalog Number : PITI-6.0-8.0 (15°)

Device Description : Integrity Implant Abutment 6.0 - 8.0mm x 15° (Angle) -7mm Height. To fit Integri Integrity Implant Abutment 6.0 - 8.0mm x 15° (Angle) -7mm Height. To fit Integrity Implants diameter sizes 6.0 to 8.0mm.

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

TatumSurgical/Integrity 2.0mm Abutment RH Screw for 3.7-5.0mm Implants - 00083208920004 Catalog Number : PITI-2.0 AS

Device Description : Integrity 2.0mm Abutment RH Screw for 3.7-5.0mm Implants

Device Class : 2

Duns Number: 078352849

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

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