Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004203816

FEI Number

3004203816

Entity Name

MIS Implants Technologies Ltd.

City/State/Country

BAR LEV INDUSTRIAL PARK Northern, IL

Establishment Address

BAR LEV INDUSTRIAL PARK P.O.BOX 7, BAR LEV INDUSTRIAL PARK Northern 2015600, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DENTSPLY SIRONA INC (Owner Number: 2511302)

Owner / Operator Contact Address

221 WEST PHILADELPHIA ST., SUITE 60W, York, PA 17401, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251647

PMA Number

N/A

All Registered Proprietary Names

Attachments Precision Attachment 4BONE BCH Connect abutment Connect abutment free rotation temporary cylinder Connect abutment healing cap Connect abutment anti rotation temporary cylinder Anti rotation cementing cap for connect abutment Free rotation cementing cap for connect abutment Orthodontic Anchor Screw MIS C1 Narrow Platform Conical Connection Implant System MIS C1 Wide Platform Conical Connection Abutments BondBone MIS Short Implants C1 MIS V3 Conical Connection Dental Implant System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-04-07
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2024-11-27
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-11-27
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-08-18
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2020-08-18
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-01-30
EGG	Attachment, Precision, All	Dental	Class 1	872.3165	2003-07-15
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-04-05
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2017-11-02
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-03-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-01-15
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2020-01-15
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2001-10-23
OAT	Implant, Endosseous, Orthodontic	Dental	Class 2	872.3640	2017-11-02
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-01-03
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-01-03
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2017-11-02
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-12-10
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2017-11-02
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2026-02-09
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2017-11-02
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-11-02
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-04-15
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-11-02
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2017-11-02
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-12-15
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2025-12-15

Official Correspondent

No official correspondent registered.

US Agent Details

Dan Eagar Business: DENTSPLY SIRONA INC Email: dan.eagar@dentsplysirona.com Phone: (704) 4926977

Related Public Records

Same Entity

DENTSPLY SIRONA INC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9612618	DEGUDENT GMBH	Rosbach V.D.H. Hesse, DE
3003756493	DENTSPLY INDUSTRIA E COMERCIO LTDA	PIRASSUNUNGA Sao Paulo, BR
3001226627	RECHERCHES TECHNIQUES DENTAIRES (R.T.D.)	ST. EGREVE Isere, FR
3003136642	OraMetrix GmbH	Berlin Brandenburg, DE
3000303964	DENTSPLY DENTAL (TIANJIN) CO., LTD.	TEDA Tianjin, CN

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 3004203816. Last updated year: 2026. Please use registration number 3004203816 when referencing this establishment in official correspondence.