Data / Medical devices / United States / Implant Direct Sybron Manufacturing LLC
Implant Direct Sybron Manufacturing LLC: FDA-registered device maker in Thousand Oaks, CA, United States, 21 510(k) clearances
Implant Direct Sybron Manufacturing LLC is registered with the FDA (registration 3001617766) in Thousand Oaks, CA, United States. It lists 8 device types. The FDA files 21 510(k) clearances under its listings, the newest dated August 16, 2023. 30 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3001617766
- Address
- 3050 East Hillcrest Drive, Thousand Oaks, CA, United States, 91362
- Owner or operator
- Implant Direct (9069060)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- November 7, 2007
- Registered through
- 2026
- Brand names listed
- Ball Abutment Housing, Ball Abutment Nylon Liner, Ball Abutment Housing & Liner, Chairside bur block, Custom Legacy and Custom InterActive Titanium Abutments, Drill Stop Kit - Long Empty, Drill Stop Kit - Short Empty, Guided Surgery Kit, Implant Direct: Tooling, Hex Driver, InterActive Complete Surgical Tray, InterActive SMARTBase Abutments and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Attachment, Precision, All | EGG | 1 | Manufacturer | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dental Abutment Design Software For Dental Laboratory | PNP | 2 | Manufacturer | accessdata.fda.gov |
| Drill, Bone, Powered | DZI | 2 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 16, 2023 | K231087 | Guided Surgery Kit | DZI | Substantially Equivalent | Implant Direct Sybron Manufacturing, LLC | accessdata.fda.gov |
| June 20, 2023 | K223535 | SMARTbase Abutment System | NHA | Substantially Equivalent | Implant Direct Sybron Manufacturing, LLC | accessdata.fda.gov |
| February 2, 2023 | K222211 | Implant Direct Dental Implant Systems Portfolio - MR Conditional | DZE | Substantially Equivalent | Implant Direct Sybron Manufacturing, LLC | accessdata.fda.gov |
| January 28, 2021 | K202524 | Standard Sterilizable Tray | KCT | Substantially Equivalent | Implant Direct Sybron Manufacturing, LLC | accessdata.fda.gov |
| January 22, 2021 | K201553 | Simply Iconic Implants | DZE | Substantially Equivalent | Implant Direct Sybron Manufacturing, LLC | accessdata.fda.gov |
| August 6, 2020 | K200858 | Mini Sterilizable Tray | KCT | Substantially Equivalent | Implant Direct Sybron Manufacturing, LLC | accessdata.fda.gov |
| June 30, 2020 | K200265 | Surgical Drills | DZI | Substantially Equivalent | Implant Direct Sybron Manufacturing, LLC | accessdata.fda.gov |
| June 25, 2020 | K192221 | Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts | DZE | Substantially Equivalent | Implant Direct Sybron Manufacturing, LLC | accessdata.fda.gov |
| May 8, 2020 | K192218 | Custom Legacy and Custom InterActive Titanium Abutments | NHA | Substantially Equivalent | Implant Direct Sybron Manufacturing, LLC | accessdata.fda.gov |
| October 10, 2019 | K191458 | Legacy SMARTBase Abutments | NHA | Substantially Equivalent | Implant Direct Sybron Manufacturing, LLC | accessdata.fda.gov |
| August 15, 2018 | K181359 | InterActive SMARTBase Abutments | NHA | Substantially Equivalent | Implant Direct Sybron Manufacturing, LLC | accessdata.fda.gov |
| April 15, 2015 | K142519 | InterActive Complete Surgical Tray | KCT | Substantially Equivalent | Implant Direct Sybron Manufacturing, LLC | accessdata.fda.gov |
| December 24, 2013 | K130572 | INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM | DZE | Substantially Equivalent | Implant Direct Sybron Manufacturing, LLC | accessdata.fda.gov |
| August 22, 2013 | K131097 | LEGACY3 6MM LENGTH IMPLANTS | DZE | Substantially Equivalent | Implant Direct Sybron Manufacturing, LLC | accessdata.fda.gov |
| May 15, 2009 | K090234 | SPECTRA SYSTEM DENTAL IMPLANTS 2008 | DZE | Substantially Equivalent | Implant Direct, LLC | accessdata.fda.gov |
| January 14, 2009 | K081396 | SWISSPLANT DENTAL IMPLANT SYSTEM | NHA | Substantially Equivalent | Implant Direct, LLC | accessdata.fda.gov |
| January 14, 2009 | K081101 | SPECTRA-SYSTEM ABUTMENTS 2008 | NHA | Substantially Equivalent | Implant Direct, LLC | accessdata.fda.gov |
| July 15, 2008 | K080633 | SCREWINDIRECT DENTAL IMPLANTS | DZE | Substantially Equivalent | Implant Direct, LLC | accessdata.fda.gov |
| May 16, 2008 | K080713 | REACTIVE DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Implant Direct, LLC | accessdata.fda.gov |
| September 29, 2006 | K061319 | SPECTRA SYSTEM | DZE | Substantially Equivalent | Implant Direct, LLC | accessdata.fda.gov |
| May 19, 2006 | K060063 | LEGACY ABUTMENT SYSTEM | NHA | Substantially Equivalent | Implant Direct, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 1, 2025 | 96778 | Class II | Ongoing | The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit includes the Release | The Drill stop kit contains incorrect components. | accessdata.fda.gov |
| May 2, 2023 | 92415 | Class II | Ongoing | LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE; LEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE LEGACY SMARTBASE NARROW NE 4 | Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established. | accessdata.fda.gov |
| September 23, 2021 | 88859 | Class II | Ongoing | ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform | Packaged dental implant contains a different size then the size declared on the labeling. | accessdata.fda.gov |
| October 11, 2019 | 84777 | Class II | Terminated | Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R | Through a customer complaint and and internal investigation it was determined that some implant packages contain the incorrect cover screw and extender. This could result in delay in surgery and/or a potential new surgical procedures to place the correct parts. The level of severity varies based on a one or two stage surgery. | accessdata.fda.gov |
| October 7, 2019 | 84801 | Class II | Terminated | Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213 | Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling. | accessdata.fda.gov |
| August 9, 2019 | 83763 | Class II | Terminated | Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants | A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered. | accessdata.fda.gov |
| January 9, 2019 | 84706 | Class II | Terminated | SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708 | Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were correct, the customer received the product they ordered, however the color on the vial label and cap labels were incorrect.Specifically, the color coded vial and cap does not match t | accessdata.fda.gov |
| November 28, 2018 | 84067 | Class II | Completed | ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. | The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion. | accessdata.fda.gov |
| October 26, 2018 | 83794 | Class II | Terminated | Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant | packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit. | accessdata.fda.gov |
| September 6, 2018 | 83573 | Class II | Terminated | Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M (4.3mmD)/UDI : 10841307123941; and 6050-09PT-M (5.00mmD)/ UDI: 10841307123958 | The action is being initiated due to incorrect assembly of the scan adapter. The result of the incorrect assembly could cause the clinician not to be able to capture the position and orientation of a dental implant(s) or lab analog during the digital scanning process which could result in a delay for the patient. | accessdata.fda.gov |
| August 8, 2018 | 83518 | Class II | Terminated | 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 Direc | Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number. | accessdata.fda.gov |
| August 7, 2018 | 83086 | Class II | Terminated | 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. | The incorrect device was packaged in the vial. | accessdata.fda.gov |
| May 29, 2018 | 80297 | Class II | Terminated | Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure. | Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label. | accessdata.fda.gov |
| May 18, 2018 | 80281 | Class II | Terminated | REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60 | Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant | accessdata.fda.gov |
| March 14, 2018 | 79793 | Class II | Terminated | ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. Product Usage: Usage: Dental implants intended fo | The cap on the vial might be labeled with the incorrect part number but the main vial label is correct. | accessdata.fda.gov |
| January 23, 2018 | 78917 | Class II | Terminated | Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform | InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized. | accessdata.fda.gov |
| January 19, 2018 | 79396 | Class II | Terminated | SwishTapered Implant Intended for use in support for fixed bridgework. | The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer). | accessdata.fda.gov |
| November 15, 2017 | 78583 | Class II | Terminated | Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for impla | The Spectra System/Legacy Guided Surgery Handle Kit had guided handle inserts that were out of Implant Direct specifications, from the results of complaints submitted by clinicians regarding the 3.4mm guide insert that will not allow the 3.4 drill to pass through, since the diameter is too small. In addition, the 2.3mm guide was too large. | accessdata.fda.gov |
| October 10, 2017 | 78350 | Class II | Terminated | ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous uppe | One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. As a result, the cap could possibly not be screwed on properly and the sterilization compromised. | accessdata.fda.gov |
| July 21, 2017 | 77788 | Class II | Terminated | Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component. | The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component. | accessdata.fda.gov |
| June 26, 2017 | 77554 | Class II | Terminated | Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the preci | The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require. | accessdata.fda.gov |
| May 2, 2017 | 77171 | Class II | Terminated | Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD | Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification. | accessdata.fda.gov |
| March 3, 2017 | 79855 | Class II | Terminated | ImplantDirect, Dental implants 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 | The main vial label lists the incorrect part number, but the cap label is correct. | accessdata.fda.gov |
| December 12, 2016 | 76111 | Class II | Terminated | SwishTapered Implant | The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient. | accessdata.fda.gov |
| November 28, 2016 | 75838 | Class II | Terminated | GoDirect Screw-Retaining Top Part Numbers: 4500-61 | Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top. | accessdata.fda.gov |
| November 15, 2016 | 79885 | Class II | Terminated | ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL. | The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled. | accessdata.fda.gov |
| July 5, 2016 | 74624 | Class II | Terminated | RePlant Angled Abutment Part Number 6050-52-60 | Issue with design specification; oversized condition. | accessdata.fda.gov |
| May 19, 2016 | 74208 | Class II | Terminated | 6534-08N InterActive Implant Open-Tray Transfer Narrow Part Number: 6534-08N Product Usage: Intended Use of Implant Direct Open Tray Transfers are to capture implant position in an elastomeric impression of the mandible | The incorrect sized product, InterActive Implant Open-Tray Transfer Wide, 6534-08W, was packaged instead of the InterActive Implant Open-tray Transfer Narrow, 6534-08N, causing a possible issue with the impression. This discrepancy may lead to the possibility of an oversized crown fabrication. | accessdata.fda.gov |
| March 4, 2016 | 73448 | Class II | Terminated | The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. GoDirect Implants Part Number: 423011, 423013, 424708, 424710, 424713, | Implant Direct Sybron Manufacturing, LLC is recalling GoDirect Implants because some consignees did not receive the correct tool to drive the implant to bone level. | accessdata.fda.gov |
| October 28, 2015 | 72549 | Class II | Terminated | DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patient needs. The thru hole | Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill. | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Dental Abutment Design Software For Dental Laboratory
- All makers of Attachment, Precision, All
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Drill, Bone, Powered
Updated July 25, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.