Data / Medical devices / United States / Suncoast Dental, Inc.

Suncoast Dental, Inc.: FDA-registered device maker in Clearwater, FL, United States, 3 510(k) clearances

Name: Suncoast Dental, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Suncoast Dental, Inc. is registered with the FDA (registration 1054986) in Clearwater, FL, United States. It lists 18 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 15, 2022. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 1054986
FEI number: 1000114355
Address: 4500 140th Ave N Ste 112, Clearwater, FL, United States, 33762
Owner or operator: SUNCOAST DENTAL, INC.. (9003013)
Roles: Repackager or relabeler, Specification developer
First device listed: October 10, 2007
Registered through: 2027
Brand names listed: 3 Diameter Straight/Offset Osteotome, 3.5 Diameter Straight/Offset Osteotome, 4 Diameter Straight/Offset Osteotome, 4.5 Diameter Straight/Offset Osteotome, 5 Diameter Straight/Offset Osteotome, 6 Diameter Straight/Offset Osteotome, 7 Diameter Offset Osteotome, 8 Diameter Offset Osteotome and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Specification developer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Attachment, Precision, All	EGG	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Chisel, Osteotome, Surgical	EMM	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Curette, Surgical, General Use	FZS	1	Repackager or relabeler	accessdata.fda.gov
Drill, Dental, Intraoral	DZA	1	Repackager or relabeler	accessdata.fda.gov
Elevator, Surgical, Dental	EMJ	1	Repackager or relabeler	accessdata.fda.gov
Gauge, Depth, Instrument, Dental	EIL	1	Repackager or relabeler	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Specification developer	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Mallet, Surgical, General & Plastic Surgery	GFJ	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Plate, Bone	JEY	2	Repackager or relabeler	accessdata.fda.gov
Positioner, Tooth, Preformed	KMY	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Retractor, All Types	EIG	1	Repackager or relabeler	accessdata.fda.gov
Screw, Fixation, Intraosseous	DZL	2	Repackager or relabeler	accessdata.fda.gov
Tap, Bone	HWX	1	Repackager or relabeler	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Repackager or relabeler, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 15, 2022	K213576	Tatum Surgical Dental Implant System	DZE	Substantially Equivalent	Suncoast Dental, Inc. Dba Tatum Surgical	accessdata.fda.gov
December 18, 2014	K141764	TRISTAR BONE GRAFT FIXATION SYSTEM	JEY	Substantially Equivalent	Impladent , Ltd.	accessdata.fda.gov
July 24, 1981	K811923	R & S SERIES IMPLANTS	DZE	Substantially Equivalent	Suncoast Dental Corp.	accessdata.fda.gov

Compare with other makers

Updated July 15, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.