Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1054986

FEI Number

1000114355

Entity Name

SUNCOAST DENTAL, INC.

City/State/Country

CLEARWATER, FL, US

Establishment Address

4500 140th Ave N Ste 112, CLEARWATER, FL 33762, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Repack or Relabel Medical Device

Owner / Operator

SUNCOAST DENTAL, INC.. (Owner Number: 9003013)

Owner / Operator Contact Address

4500 140th Avenue North, SUITE 112, Clearwater, FL 33762, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bone Caliper Retractor TC / UofM Scalpel Handle Bone Carrier Forceps Adson/Tissue/Micro Boley Gauge Bone Cutter Bone Expander Kit Orban Knife Tunneling Kit Post Holder Scissors Gfox/Metz/Castroviejo Straight/Curved EZ-Universal Driver Short/Long Bending Pliers Bone Molder Seldin Ruler EZ-Implant Driver EZ-Screw Fixation Driver Handle Needle Holder Periosteal Elevators Single/Kit Sinus Curette 1,2,3,4,5,6,7,8,9,10 Periotome 1,2,3,4,5,6,7 Suncoast Dental, Inc. Dba Tatum Surgical Suncoast Dental, Inc. Suncoast Dental, Inc. Dba Tatum Surgical Depth Gauge Tatum Surgical Integrity Implant Kit Box One-Piece Implant Kit Box Osteotome Box Periotome Box Small Stainless Tray Large Stainless Tray Sinus Box Tapered Implant Kit Box Autoclavable Cassette 4x7.5x1.5, 7.5x2.5, 6x10x0.75 Ht1 HT6U HT6 HT2 HT.18 HT7 HT3 Ratchet HT.26 HT8 HT.17 HT.23 HT.12 HT.30 HT.10 HT7D HT.15 HT.16 HT.20 HT.21 HT3L HT4 HT7L HT.29 HT6L HT5 HT.19 HT7U HT.27 HT.13A HT.22 HT9L HT.31A HT.32A HT.14 HT9 HT.11 Pilot Drill 1, 1.5, 1.8, 2 Tapered Drill 7x11,14,17 Tapered Drill 4x11,14,17,20 Tapered Drill 4.5x11,14,17,20 Tapered Drill 6x11,14,17,20 Tapered Drill 5x11,14,17,20 Tapered Drill 3.5x11,14,17,20 Tapered Drill 8x11,14,17 Tapered Tap 6x11, 6x14, 6x17, 6x20 Tapered Tap 7x11, 7x14, 7x17 Tapered Tap 8x11, 8x14, 8x17 Tapered Tap 4.5x11, 4.5x14, 4.5x17, 4.5x20 Tapered Tap 5x11, 5x14, 5x17, 5x20 Serrated Miller 9JS, 10S, 12S Post Guide Straight, 10, 20, 30 Paralleling Pin Tapered Socket Guide 3.3, 3.8, 4.3, 4.8 Rongeur Mallet

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2023-06-13
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2018-03-15
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-10-07
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-10-07
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2007-10-10
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-10-07
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-10-07
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2018-03-15
JEY	Plate, Bone	Dental	Class 2	872.4760	2018-03-15
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2018-03-15
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2023-06-13
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2018-03-15
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2018-03-15
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2023-06-13
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2023-06-13
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2023-06-13
EIG	Retractor, All Types	Dental	Class 1	872.4565	2018-03-15
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2023-06-13

Official Correspondent

Tony Fiorello

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SUNCOAST DENTAL, INC..

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14
K903999	O Co., Inc.	OBUTMENT HB	1992-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Z-0029-05	Implant Innovations, Inc.	2	EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

Similar Registrations

Registration Number	Establishment Name	Location
9612124	AIR WATER REALIZE INC.	IWAKI-SHI Fukushima, JP
3015235469	KOEHRER MEDICAL ENGINEERING GMBH	Neuss North Rhine-Westphalia, DE
1815540	TP ORTHODONTICS, INC.	LA PORTE, IN, US
3003963832	PDT, INC.	MSLA, MT, US
1051594	CORDICA MEDICAL, INC. (Formally TEAM Technologies, Inc.)	MORRISTOWN, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1054986. Last updated year: 2026. Please use registration number 1054986 when referencing this establishment in official correspondence.