Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004201263

FEI Number

3004201263

Entity Name

S.I.N. Implant System Ltda

City/State/Country

SAO PAULO, BR

Establishment Address

Rua Soldador Ocimar Guimaraes da Silva 421, Jardim Analia Franco, SAO PAULO 03348-060, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

S.I.N. - SISTEMA DE IMPLANTE NACIONAL S.A (Owner Number: 9059509)

Owner / Operator Contact Address

Soldador Ocimar Guimaraes da Silva Street, 421, Vereador Abel Ferreira Avenue, 2140 (only social entrance), Sao Paulo, BR-SP 03348-060, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211921

PMA Number

N/A

All Registered Proprietary Names

S.I.N. Instrument Kits S.I.N. Dental Implant System S.I.N. Dental Implant System S.I.N. Dental Implant System S.I.N. Dental Implant System Sistema de Implante Nacional (S. I. N.) Dental Implant System S.I.N. Dental Implant System S.I.N. Dental Implant System S.I.N. Instrument Kits S.I.N. Dental Implant System BioHorizons Sistema de Implante Nacional (S. I. N.) Dental Implant Accessories S.I.N. Dental Implant System S.I.N. Instrument Kit S.I.N. Dental Implant System S.I.N. Dental Implant System S.I.N. Dental Implant System S.I.N. Dental Implant System S.I.N. Dental Implant System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2021-11-03
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-12-16
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-12-16
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2025-11-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-11-17
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2020-05-14
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-05-14
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2025-11-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2004-02-25
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2004-02-25
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-04-07
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2017-12-05
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-12-05
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2020-12-02
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-12-02
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2020-12-02
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2016-11-21
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-06-23
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-06-23
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2024-07-15
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-11-11
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-11-11
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2024-07-18
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-07-18
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2025-11-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-11-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-12-11
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2023-12-11
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-10-20

Official Correspondent

No official correspondent registered.

US Agent Details

Floyd Larson Business: PAXMED INTERNATIONAL, LLC Email: flarson@paxmed.com Phone: (858) 7921235

Related Public Records

Same Entity

S.I.N. - SISTEMA DE IMPLANTE NACIONAL S.A

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
K243425	Talladium España, SL	Guided DAS Surgical Kit	2025-07-22
K213209	K1 Medical, LLC	EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device	2021-12-28
K012105	Symmetry Medical, Inc.	POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM	2002-08-02
K243317	Infinitum Eta, Ltd.	NUVENTUS NV.C Surgical Cassette and Tray	2025-02-11
K112536	Covidien	SONICISION STERILIZATION TRAY	2012-04-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
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-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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004201263. Last updated year: 2026. Please use registration number 3004201263 when referencing this establishment in official correspondence.