RegWardenFDA facility compliance records
Facility

IMPLANT DIRECT SYBRON MANUFACTURING LLC

30 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2015: 1 recalls; 2016: 6 recalls; 2017: 6 recalls; 2018: 10 recalls; 2019: 4 recalls, 1 inspections; 2021: 1 recalls, 1 inspections; 2023: 1 recalls; 2025: 1 recalls120156201662017102018520192020220212022120232024120252026
  • Recalls (30)
  • Inspections (2)

Devices registered here (2)

  • Dental Abutment Design Software For Dental Laboratory
    Product code PNP (opens in a new tab) · Class II · Dental · 21 CFR 872.3630
  • Abutment, Implant, Dental, Endosseous
    Product code NHA (opens in a new tab) · Class II · Dental · 21 CFR 872.3630

Recalls & enforcement

20251 record
20231 record
  • Class IIOngoing2023-05-02
    Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
20211 record
20194 records
  • Class IITerminated2019-10-11
    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 se…
  • Class IITerminated2019-10-07
    Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.
  • Class IITerminated2019-08-09
    A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.
  • Class IITerminated2019-01-09
    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 …
201810 records
  • Class IICompleted2018-11-28
    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.
  • Class IITerminated2018-10-26
    packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.
  • Class IITerminated2018-09-06
    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…
  • Class IITerminated2018-08-08
    Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number.
  • Class IITerminated2018-08-07
    The incorrect device was packaged in the vial.
  • Class IITerminated2018-05-29
    Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.
  • Class IITerminated2018-05-18
    Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant
  • Class IITerminated2018-03-14
    The cap on the vial might be labeled with the incorrect part number but the main vial label is correct.
  • Class IITerminated2018-01-23
    InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized.
  • Class IITerminated2018-01-19
    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).
20176 records
  • Class IITerminated2017-11-15
    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 diame…
  • Class IITerminated2017-10-10
    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 steriliz…
  • Class IITerminated2017-07-21
    The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.
  • Class IITerminated2017-06-26
    The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.
  • Class IITerminated2017-05-02
    Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification.
  • Class IITerminated2017-03-03
    The main vial label lists the incorrect part number, but the cap label is correct.
20166 records
  • Class IITerminated2016-12-12
    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-…
  • Class IITerminated2016-11-28
    Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top.
  • Class IITerminated2016-11-15
    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.
  • Class IITerminated2016-07-05
    Issue with design specification; oversized condition.
  • Class IITerminated2016-05-19
    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 cro…
  • Class IITerminated2016-03-04
    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.
20151 record
  • Class IITerminated2015-10-28
    Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill.

FDA inspections (2)

  • NAI2021-05-12
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • OAI2019-12-02
    Official Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “IMPLANT DIRECT SYBRON MANUFACTURING LLC (FEI 3001617766) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3001617766-implant-direct-sybron-manufacturing-llc/

Not open yet

Alerts for IMPLANT DIRECT SYBRON MANUFACTURING LLC

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.