Implant Direct Sybron Manufacturing, LLC
Implant Direct Sybron Manufacturing, LLC holds FDA 510(k) medical device clearances, first cleared 2013, most recent 2023, with 33 FDA device recalls on record.
Top product codes for Implant Direct Sybron Manufacturing, LLC
FDA recalls by Implant Direct Sybron Manufacturing, LLC
10 most recent of 33- Z-2172-2025 — 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 Bracket, which is used for mounting and removing Drill Stops, as well as verifying the length of the Drill Stops via a ruler and depth markings. The Drill Stop Kit also allows for optional storage of some DLC drills. Drill Stops: The Drill Stop is a reusable (up to 30 osteotomies) hollow cylinder with retention prongs that clips onto the hub of the DLC drill, creating a stop function at the desired predetermined drill depth (6mm, 8mm, 10mm, 11.5mm, 13mm and 16mm). The Drill Stops come in two formats (Short 6-13mm depth, and Long 6-16mm depth), and in several diameters for different diameter drills.
- Z-2037-2023 — 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 4.5D, REF: 8745-80NNE; LEGACY SMARTBASE. NE 4.5D, REF: 8745-82NE;
- Z-0197-2022 — ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
- Z-0198-2022 — ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
- Z-1157-2020 — Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,
- Z-1041-2020 — Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
- Z-0364-2020 — Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
- Z-1126-2020 — SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
- Z-0791-2020 — 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.
- Z-0790-2020 — 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Implant Direct Sybron Manufacturing, LLC
- K231087 — Guided Surgery Kit
- K223535 — SMARTbase Abutment System
- K222211 — Implant Direct Dental Implant Systems Portfolio - MR Conditional
- K202524 — Standard Sterilizable Tray
- K201553 — Simply Iconic Implants
- K200858 — Mini Sterilizable Tray
- K200265 — Surgical Drills
- K192221 — Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts
- K192218 — Custom Legacy and Custom InterActive Titanium Abutments
- K191458 — Legacy SMARTBase Abutments
- K181359 — InterActive SMARTBase Abutments
- K162633 — Custom Bars
- K153509 — GPS Angled Abutment
- K143011 — 2014 InterActive/SwishActive System
- K142519 — InterActive Complete Surgical Tray
- K130572 — INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM
- K131097 — LEGACY3 6MM LENGTH IMPLANTS
Data sourced from openFDA. This site is unofficial and independent of the FDA.