510(k) Report

FDA applicant

Implant Direct Sybron Manufacturing, LLC

Thousand Oaks, CA17 decisions2013–20238 recalls

FDA records 17 decisions for Implant Direct Sybron Manufacturing, LLC (Thousand Oaks, CA) from 2013 to 2023: 17 510(k) clearances. Most are in product codes NHA (Abutment, Implant, Dental, Endosseous) and DZE (Implant, Endosseous, Root-Form). Since 2016 its 510(k)s took a median of 201 days from receipt to decision, against 187 for FDA’s reviews in the same codes and years. Its devices cite 35 predicates, 10 of them its own earlier devices. 8 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Implant Direct Sybron Manufacturing, LLC’s devices, and how often a recall has named them.

FDA decisions per year

3in 2023

2013: 22015: 22016: 12017: 12018: 12019: 12020: 42021: 22023: 3
2013high 4 (2020) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2025

2017: 12018: 32021: 22023: 12025: 1
2013high 3 (2018) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Implant Direct Sybron Manufacturing, LLC by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Implant Direct Sybron Manufacturing, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NHAAbutment, Implant, Dental, Endosseous6decisions
  • DZEImplant, Endosseous, Root-Form6decisions
  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories3decisions
  • DZIDrill, Bone, Powered2decisions

How long do its 510(k) reviews take?

Since 2016, its 12 510(k)s took a median of 201 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 187 days; 6 of its 12 were faster than that.

Whose devices does it build on?

Its devices cite 35 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 19 times; 10 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K142519InterActive Complete Surgical TrayImplant Direct Sybron Manufacturing, LLC · 20155cite it
  • K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC · 20133cite it
  • K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 20182cite it
  • K192221Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4…Implant Direct Sybron Manufacturing, LLC · 20202cite it
  • K202524Standard Sterilizable TrayImplant Direct Sybron Manufacturing, LLC · 20212cite it
  • K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC · 20152cite it

What has FDA decided for it lately?

  • K231087Guided Surgery KitImplant Direct Sybron Manufacturing, LLC · 2023
  • K223535SMARTbase Abutment SystemImplant Direct Sybron Manufacturing, LLC · 20231 recall
  • K222211Implant Direct Dental Implant Systems Portfolio - MR ConditionalImplant Direct Sybron Manufacturing, LLC · 2023
  • K202524Standard Sterilizable TrayImplant Direct Sybron Manufacturing, LLC · 2021
  • K201553Simply Iconic ImplantsImplant Direct Sybron Manufacturing, LLC · 2021
  • K200858Mini Sterilizable TrayImplant Direct Sybron Manufacturing, LLC · 20201 recall
  • K200265Surgical DrillsImplant Direct Sybron Manufacturing, LLC · 2020
  • K192221Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4…Implant Direct Sybron Manufacturing, LLC · 20202 recalls

All 17 as Implant Direct Sybron Manufacturing, LLC →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K200858The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store…May 1, 2025Class II
  • K223535Legacy Smartbase, NE 3.0D 1MML, Ref: 8730-81NE; Legacy Smartbase, NE 3.0D 2MML, Ref…May 2, 2023Class II
  • K192221ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,Sep 23, 2021Class II
  • K192221ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,Sep 23, 2021Class II
  • K130572Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x…Oct 26, 2018Class II
  • K130572ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part…Mar 14, 2018Class II

Other applicant names beginning “Implant”

FDA records each applicant name separately; these may or may not be the same firm.

Implant Innovations, Inc. 51Implant Center of the Palm Beaches 32Implant Innovations International, Inc. 18Implant Technology, Inc. 13Implant Support Systems, Inc. 10Implant Direct, LLC 10Implant Protesis Dental 2004, S.L. 6Implant Sciences Corp. 6Implant Integration Systems, Inc. 4Implant Logistics, Inc. 3Implant Corp. of America 3Implant Solutions Pty Ltd (Aka Osteon Medical) 2