Recall Register

Implant Direct Sybron Manufacturing LLC: FDA recalls

FDA enforcement reports name Implant Direct Sybron Manufacturing LLC as the recalling firm in 30 events. The events have 33 product records. The recalls started from 2015 to 2025. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

30 events, newest first.

FDA enforcement events of Implant Direct Sybron Manufacturing LLC
InitiatedProduct (first record)TypeClassRecordsStatus
1 May 2025The 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…DeviceClass II1Ongoing
2 May 2023LEGACY 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;DeviceClass II1Ongoing
23 Sep 2021ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,DeviceClass II2Ongoing
11 Oct 2019Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,DeviceClass II1Terminated
7 Oct 2019Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213DeviceClass II1Terminated
9 Aug 2019Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental ImplantsDeviceClass II1Terminated
9 Jan 2019SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708DeviceClass II1Terminated
28 Nov 2018ImplantDirect 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.DeviceClass II2Completed
26 Oct 2018Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental ImplantDeviceClass II1Terminated
6 Sep 2018Implant 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: 10841307123958DeviceClass II1Terminated
8 Aug 2018ImplantDirect 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…DeviceClass II1Terminated
7 Aug 2018ImplantDirect 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.DeviceClass II1Terminated
29 May 2018Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.DeviceClass II1Terminated
18 May 2018REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60DeviceClass II1Terminated
14 Mar 2018ImplantDirect 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 for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit…DeviceClass II1Terminated
23 Jan 2018Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD PlatformDeviceClass II1Terminated
19 Jan 2018SwishTapered Implant Intended for use in support for fixed bridgework.DeviceClass II2Terminated
15 Nov 2017Spectra 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 implant placement with the precision and accuracy as designed with treatment planning software. The…DeviceClass II1Terminated
10 Oct 2017ImplantDirect 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 upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate…DeviceClass II1Terminated
21 Jul 2017Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.DeviceClass II1Terminated
26 Jun 2017Spectra-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 precision and accuracy as designed with treatment planning software. The G-HK consist of 4 guide…DeviceClass II1Terminated
2 May 2017Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmDDeviceClass II1Terminated
3 Mar 2017ImplantDirect, 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.DeviceClass II1Terminated
12 Dec 2016SwishTapered ImplantDeviceClass II1Terminated
28 Nov 2016GoDirect Screw-Retaining Top Part Numbers: 4500-61DeviceClass II1Terminated
15 Nov 2016ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.DeviceClass II1Terminated
5 Jul 2016RePlant Angled Abutment Part Number 6050-52-60DeviceClass II1Terminated
19 May 20166534-08N 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 or maxilla. Open Tray transfers stay within the Impression material prior to delivery to the…DeviceClass II1Terminated
4 Mar 2016The 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, 424713,433010,433710DeviceClass II1Terminated
28 Oct 2015DGDE, 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 in the DGDE allows existing surgical drills to be inserted and locked in place.DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Implant Direct Sybron Manufacturing LLC: events for each product type
TypeEvents
Device30
Implant Direct Sybron Manufacturing LLC: events in each class
ClassEvents
Class II30
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
3

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Implant Direct Sybron Manufacturing LLC, by the year that the recall started. The largest year is 2018, with 10 events.

Official channels

Cite this page

Recall Register. Implant Direct Sybron Manufacturing LLC: FDA recalls. https://recallregister.com/firm/implant-direct-sybron-manufacturing-llc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
CA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Implant Direct Sybron Manufacturing LLC have?
Class II: 30 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Implant Direct Sybron Manufacturing LLC?
FDA event 96778, which the firm started on 1 May 2025. The first product in the record is: 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…
How many FDA recalls of Implant Direct Sybron Manufacturing LLC have the status Ongoing?
3 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.