Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008261720

FEI Number

3008261720

Entity Name

JJGC Industria e Comercio de Materiais Dentarios SA

City/State/Country

Curitiba Parana, BR

Establishment Address

Avenida Juscelino Kubitschek de Olivera, 3291, Curitiba Parana 81270-200, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INSTITUT STRAUMANN AG (Owner Number: 9005052)

Owner / Operator Contact Address

PETER MERIAN-WEG 12, BASEL, CH-NOTA CH-4002, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

REF06 ClearCorrect System Engager Template REF02 ClearCorrect System Engager Template Novaloc Equator Attachment Optiloc Neodent Graft Screw Neodent Implant System - Easy Pack Neodent Dental Hand Instruments Neodent Implant for Orthodontic Anchorage Neodent Implant System Helix Short Implant System Neodent Instrument Kits Neodent Bone Mill Neodent Implant System - GM Titanium Base for Bridge Chisel Neodent Implant System - Temporary Abutments Neodent Custom Abutments AS Ti, ASC Screws Straumann Dental Implant System Neodent Implant System - Neodent EasyGuide Kit Case Neodent Implant System Neodent Implant System NUVO Implant System - NUVO Instrument Kit Cases Neodent Implant System Dental Implant Accesories Neodent Instrument Kit Cases Neodent Implant System - Zygomatic Implants and Abutments Neodent Retractor Titamax CM Neodent Implant System Neodent Implant System Complement Kit Cases EUROPOST EXCELPOST REF04 ClearCorrect System Retainer Neodent Implant System - Acqua Implants Neodent Implant System GM Zygomatic Implant System NUVO CF Implant System Neodent Implant System - Zirconia Implant System Straumann Dental Implant System Neodent Implant System Neodent Implant System-Helix NGM Compact Surgical Kit Cases Neodent Dental Implant Abutments Neodent Implant System - GM Line Neodent Implant System - Zirconia Implant System Neodent Curette Neodent Implant System - Helix Short Surgical Kit Cases Zirconia Base Neodent Implant System - Zirconia Implant System Neodent Surgical Tray

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QJJ	Indirect Bonding Tray	Dental	Class 1	872.5410	2023-01-21
EGG	Attachment, Precision, All	Dental	Class 1	872.3165	2021-08-03
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2021-10-19
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2021-11-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-11-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-11-13
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2021-11-13
OAT	Implant, Endosseous, Orthodontic	Dental	Class 2	872.3640	2021-11-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-06-28
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2023-06-28
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2021-11-13
LYS	Bone Mill	Orthopedic	Class 1	888.4540	2021-11-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-11-13
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	2021-11-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-11-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-06-25
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-08-27
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	1999-07-02
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2021-11-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2026-02-18
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2026-02-18
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-11-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-11-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-11-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-11-13
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2021-11-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-11-13
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2007-06-29
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2021-11-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-11-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-11-13
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2021-11-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-11-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-11-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-11-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-11-13
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2026-02-18
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2026-02-18
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-11-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-11-13
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2023-08-09
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2021-10-19
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2023-01-21
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-11-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-11-14
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2023-11-14
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-11-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-11-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-11-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-11-13
EJL	Bur, Dental	Dental	Class 1	872.3240	2011-05-19
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-11-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-07-12
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2022-04-18
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-11-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-11-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-11-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-01-12
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-07-12
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	2021-11-13
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2023-06-06
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2026-03-23
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-11-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-11-13
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2021-11-13

Official Correspondent

No official correspondent registered.

US Agent Details

Jennifer M Jackson Business: Straumann USA, LLC Email: jennifer.jackson@straumann.com Phone: (978) 7472509

Related Public Records

Same Entity

INSTITUT STRAUMANN AG

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010377510	DENTAL WINGS GMBH	Chemnitz Saxony, DE
1222315	Straumann USA, LLC	ANDOVER, MA, US
3007130440	ClearCorrect , LLC	Round Rock, TX, US
3026444199	Medentika GmbH	Calw Baden-Wurttemberg, DE
3007218081	Straumann Villeret SA	Corgemont Bern, CH

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008261720. Last updated year: 2026. Please use registration number 3008261720 when referencing this establishment in official correspondence.