Company ยท US
Implant Direct Sybron Manufacturing, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2023. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
33recalls (0 in 12 months)
26recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 25 |
| NHA | Abutment, Implant, Dental, Endosseous | 12 |
| NDP | Accessories, Implant, Dental, Endosseous | 5 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 4 |
| DZI | Drill, Bone, Powered | 2 |
| EHY | Tray, Impression, Preformed | 1 |
| LXH | Orthopedic Manual Surgical Instrument | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 16, 2023 | K231087 | Guided Surgery Kit Implant Direct Sybron Manufacturing, LLC | DZI |
| Jun 20, 2023 | K223535 | SMARTbase Abutment System Implant Direct Sybron Manufacturing, LLC | NHA |
| Feb 2, 2023 | K222211 | Implant Direct Dental Implant Systems Portfolio - MR Conditional Implant Direct Sybron Manufacturing, LLC | DZE |
| Jan 28, 2021 | K202524 | Standard Sterilizable Tray Implant Direct Sybron Manufacturing, LLC | KCT |
| Jan 22, 2021 | K201553 | Simply Iconic Implants Implant Direct Sybron Manufacturing, LLC | DZE |
| Aug 6, 2020 | K200858 | Mini Sterilizable Tray Implant Direct Sybron Manufacturing, LLC | KCT |
| Jun 30, 2020 | K200265 | Surgical Drills Implant Direct Sybron Manufacturing, LLC | DZI |
| Jun 25, 2020 | K192221 | Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts Implant Direct Sybron Manufacturing, LLC | DZE |
| May 8, 2020 | K192218 | Custom Legacy and Custom InterActive Titanium Abutments Implant Direct Sybron Manufacturing, LLC | NHA |
| Oct 10, 2019 | K191458 | Legacy SMARTBase Abutments Implant Direct Sybron Manufacturing, LLC | NHA |
| Aug 15, 2018 | K181359 | InterActive SMARTBase Abutments Implant Direct Sybron Manufacturing, LLC | NHA |
| Jul 24, 2017 | K162633 | Custom Bars Implant Direct Sybron Manufacturing, LLC | NHA |
| Aug 26, 2016 | K153509 | GPS Angled Abutment Implant Direct Sybron Manufacturing, LLC | NHA |
| Jul 16, 2015 | K143011 | 2014 InterActive/SwishActive System Implant Direct Sybron Manufacturing, LLC | DZE |
| Apr 15, 2015 | K142519 | InterActive Complete Surgical Tray Implant Direct Sybron Manufacturing, LLC | KCT |
| Dec 24, 2013 | K130572 | INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM Implant Direct Sybron Manufacturing, LLC | DZE |
| Aug 22, 2013 | K131097 | LEGACY3 6MM LENGTH IMPLANTS Implant Direct Sybron Manufacturing, LLC | DZE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 25, 2025 | Implant Direct Sybron Manufacturing LLC 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 i Open, Classified |
KCT | K200858 |
| Jun 29, 2023 | Implant Direct Sybron Manufacturing LLC 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 S Open, Classified |
NHA | K223535 |
| Sep 23, 2021 | Implant Direct Sybron Manufacturing LLC ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform, Open, Classified |
DZE | K192221 |
| Sep 23, 2021 | Implant Direct Sybron Manufacturing LLC ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform, Open, Classified |
DZE | K192221 |
| Feb 10, 2020 | Implant Direct Sybron Manufacturing LLC SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708 Terminated |
NHA | K081396 |
| Feb 5, 2020 | Implant Direct Sybron Manufacturing LLC Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R, Terminated |
DZE | K090234 |
| Feb 4, 2020 | Implant Direct Sybron Manufacturing LLC Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213 Terminated |
DZE | K090234 |
| Nov 12, 2019 | Implant Direct Sybron Manufacturing, LLC Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA
Dental Implants Terminated |
DZE | K090234 |
| Nov 28, 2018 | Implant Direct Sybron Manufacturing, LLC ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. Completed |
NDP | None listed |
| Nov 28, 2018 | Implant Direct Sybron Manufacturing, LLC 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. Completed |
NDP | None listed |
| Oct 26, 2018 | Implant Direct Sybron Manufacturing, LLC Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R
Dental Implant Terminated |
DZE | K130572 |
| Sep 6, 2018 | Implant Direct Sybron Manufacturing, LLC 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)/ Terminated |
NDP | None listed |
| Aug 8, 2018 | Implant Direct Sybron Manufacturing, LLC 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 Terminated |
DZE | K090234 |
| Aug 7, 2018 | Implant Direct Sybron Manufacturing, LLC 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. Terminated |
DZE | K061319 |
| May 29, 2018 | Implant Direct Sybron Manufacturing, LLC Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure. Terminated |
NDP | None listed |
| May 18, 2018 | Implant Direct Sybron Manufacturing, LLC REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60 Terminated |
DZE | K061319 |
| Mar 14, 2018 | Implant Direct Sybron Manufacturing, LLC 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:
Den Terminated |
DZE | K130572 |
| Jan 23, 2018 | Implant Direct Sybron Manufacturing, LLC Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform Terminated |
NHA | K130572 |
| Jan 19, 2018 | Implant Direct Sybron Manufacturing, LLC SwishPlus Implant
Intended for use in support for fixed bridgework. Terminated |
NHA | K081396 |
| Jan 19, 2018 | Implant Direct Sybron Manufacturing, LLC SwishTapered Implant
Intended for use in support for fixed bridgework. Terminated |
DZE | K090234 |
| Nov 15, 2017 | Implant Direct Sybron Manufacturing, LLC 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 Terminated |
NDP | None listed |
| Oct 10, 2017 | Implant Direct Sybron Manufacturing, LLC 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 Terminated |
DZE | K090234 |
| Jul 21, 2017 | Implant Direct Sybron Manufacturing, LLC Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component. Terminated |
NHA | K090234 |
| Jun 26, 2017 | Implant Direct Sybron Manufacturing, LLC 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 p Terminated |
LXH | None listed |
| May 2, 2017 | Implant Direct Sybron Manufacturing, LLC Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD Terminated |
DZE | K061319 |
| Mar 3, 2017 | Implant Direct Sybron Manufacturing, LLC 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 Terminated |
DZE | K130572 |
| Jan 28, 2017 | Implant Direct Sybron Manufacturing, LLC SwishTapered Implant Terminated |
DZE | K090234 |
| Jan 9, 2017 | Implant Direct Sybron Manufacturing, LLC GoDirect Screw-Retaining Top
Part Numbers: 4500-61 Terminated |
DZE | K090234 |
| Nov 15, 2016 | Implant Direct Sybron Manufacturing, LLC 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. Terminated |
DZE | K090234 |
| Aug 2, 2016 | Implant Direct Sybron Manufacturing, LLC RePlant Angled Abutment
Part Number 6050-52-60 Terminated |
DZE | K061319 |
| May 19, 2016 | Implant Direct Sybron Manufacturing, LLC 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 impre Terminated |
EHY | None listed |
| Mar 4, 2016 | Implant Direct Sybron Manufacturing, LLC 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, 4 Terminated |
DZE | K090234 |
| Dec 8, 2015 | Implant Direct Sybron Manufacturing, LLC 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 patie Terminated |
NHA | K081396 |