Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001617766

FEI Number

3001617766

Entity Name

IMPLANT DIRECT SYBRON MANUFACTURING LLC

City/State/Country

Thousand Oaks, CA, US

Establishment Address

3050 East Hillcrest Drive, Thousand Oaks, CA 91362, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Implant Direct (Owner Number: 9069060)

Owner / Operator Contact Address

3050 East Hillcrest Drive, --, Thousand Oaks, CA 91362, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K142519

PMA Number

N/A

All Registered Proprietary Names

InterActive/SwishPlus2 Implant System K061319 Spectra System: Legacy, RePlant, Simply Replant, ScrewIndirect Simply Legacy 3, Legacy3 6mm Length Implant System Spectra-System Abutments 2008: Legacy, RePlant, ScrewPlus, ScrewPlant, ScrewIndirect Legacy SMARTbase Abutments Standard Sterilizable Tray Custom Legacy and Custom InterActive Titanium Abutments Chairside bur block InterActive SMARTBase Abutments SIMPLY ICONIC Implants SwishPlant Dental Implant System Mini Sterilizable Tray Drill Stop Kit - Long Empty, Drill Stop Kit - Short Empty Implant Direct: Tooling, Hex Driver OEM: Stainless Steel Ratchet, 30Ncm Torque Wrench, Torque Wrench Multi-Setting, Stainless Steel Handle - Multiple Guided Surgery Kit K060063 Legacy Abutment System K080713 ReActive Dental Implant System K090234 Legacy, GoDirect, RePlant, Simply Replant, ScrewIndirect K080633 ScrewIndirect Dental Implants Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts InterActive Complete Surgical Tray

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2014-02-28
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2014-02-28
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2007-11-07
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2013-09-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2009-01-16
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2019-11-06
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-11-06
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2021-02-23
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-06-16
EJL	Bur, Dental	Dental	Class 1	872.3240	2018-02-21
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2018-09-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-09-10
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-02-23
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2009-01-16
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2020-09-11
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2015-07-13
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2023-08-28
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2023-08-28
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2007-11-07
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2008-08-06
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-08-06
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2009-07-07
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-07-07
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-08-06
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2020-07-27
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-07-27
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2015-04-22

Official Correspondent

Laura Caltagirone

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Implant Direct

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
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-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-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 3001617766. Last updated year: 2026. Please use registration number 3001617766 when referencing this establishment in official correspondence.