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IMPLANT DIRECT SYBRON MANUFACTURING LLC

Last updated September 17, 2026

Information

Country: US
Address: 3050 East Hillcrest Drive, Thousand Oaks, CA, 91362
Website: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3001617766
DUNS Number: —

Catalogue (3216)

Page 3 of 65

Device	Model / Reference	Registries	Class	Status
DIRECTarch™ Temporary Abutment Screw (5Pk)	DA1000-05	FDA UDI	Class II	Active
Extra Long Fixation Screw (2 pieces)	1000-10XL	FDA UDI	Class II	Unknown
SwishActive™ Implant	944812	FDA UDI	Class II	Active
Interpore - IMZ .050"/1.25mm Hex Screw	57-440052	FDA UDI	Class II	Active
DIRECTguide™ Step Drill	GSD4.4-10	FDA UDI	Class II	Active
Multi-Unit Abutment Screw Short	1000-01S	FDA UDI	Class II	Active
Legacy™ GPS® Abutment	8045-91	FDA UDI	Class II	Active
Legacy™4 Implant	877006	FDA UDI	N/A	Unknown
Legacy™3 Implant	855211	FDA UDI	Class II	Active
Swish™ Complete Surgical Tray	SPCST	FDA UDI	Class II	Active
RePlant® Multi-Unit Abutment	6050-61	FDA UDI	N/A	Active
InterActive® Healing Collar Wide	6534-13W	FDA UDI	Class II	Active
Multi-Unit Abutment Temporary Coping	1000-69	FDA UDI	Class II	Active
Simply Iconic™ / InterActive™ DRIVER	HT2.7LG	FDA UDI	Class I	Active
DLC Step Drill 5.4/4.8mm (6-16mmL)	SD5.4C	FDA UDI	Class II	Active
InterActive® Gold Non-Engaging Abutment	6534-41	FDA UDI	Class II	Active
Duo-Grip™ Short Fixation Screw (2 pieces)	1000-20	FDA UDI	Class II	Unknown
Simply Iconic™ / InterActive™ Implant Open-Tray Transfer	6534-08	FDA UDI	Class I	Active
InterActive™ DIRECTarch™ 3.4mmD Platform 30 Degree MUA 3.5mmL Collar	DA6534-63-30	FDA UDI	Class II	Active
UCLA Ti Temporary Hex Cylinder and .050"/1.25mm Hex Screw - Branemark RP 4.1 Com	44-000302	FDA UDI	Class II	Active
Legacy™ Zirconia Str. Contoured Abutment	8530-31C	FDA UDI	N/A	Unknown
Legacy™4 Implant	883708	FDA UDI	Class II	Active
Legacy™3 Implant	853710	FDA UDI	Class II	Active
Replant Soft Bone Step Drill Short	RSB3S	FDA UDI	Class II	Active
Long Fixation Screw	1000-26	FDA UDI	Class II	Active
DirectOss™	DXCA102025	FDA UDI	Class II	Active
InterActive™ Fixture-Mount	6534-02	FDA UDI	Class II	Active
simplyCrown&Bridge RePlant®	6043-22K	FDA UDI	Class II	Active
ReActive® Implant	755708	FDA UDI	Class II	Active
Simply Iconic™ / InterActive™ Angled Contoured Abutment	6530-51	FDA UDI	Class II	Active
ScrewPlus® Implant	215711	FDA UDI	Class II	Active
Straight Abutment Transfer - Short	8747-02	FDA UDI	Class I	Active
RePlant® Straight Contoured Abutment	6035-31	FDA UDI	Class II	Active
Legacy™ Implant Open-Tray Transfer-Concave Profile Non-Engaging	8730-08NE	FDA UDI	Class I	Active
InterActive® SMARTbase, Narrow	6530-82N	FDA UDI	Class II	Active
Legacy™3 Implant	865216	FDA UDI	Class II	Active
Legacy™2 Implant	834710	FDA UDI	Class II	Active
Simply Iconic™ / InterActive™ Straight Abutment	6534-23	FDA UDI	Class II	Active
DLC Drill Stop	DSR10S	FDA UDI	Class I	Active
UCLA .050"/1.25mm Hex Screw Branemark RP 4.1 Compatible	44-000052	FDA UDI	Class II	Active
ReActive® Implant	763713	FDA UDI	Class II	Active
Legacy™4 Implant	874211	FDA UDI	Class II	Active
Legacy™ Healing Collar Concave Profile Narrow	8745-15N	FDA UDI	Class II	Active
InterActive® Surgical Tray	IST	FDA UDI	Class II	Active
Legacy™ Straight Abutment Full-Contour Profile	HLA4-6	FDA UDI	N/A	Unknown
ScrewPlant® Zirconia Angled Contoured Abutment	1047-52-08C	FDA UDI	N/A	Unknown
Legacy™ SMARTbase Narrow, Non-Engaging	8745-80NNE	FDA UDI	Class II	Active
Simply Iconic™ / InterActive™ Ball Abutment Narrow	6534-73N	FDA UDI	Class II	Active
Off-Axis Wrench Tool Short	HT1.3SB	FDA UDI	Class I	Active
Legacy™ Plastic Engaging Temporary Abutment	8035-47	FDA UDI	Class II	Active

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FDA Recalls (33)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 1, 2025	Z-2172-2025	—	open, classified	The Drill stop kit contains incorrect components.
May 2, 2023	Z-2037-2023	—	open, classified	Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
Sep 23, 2021	Z-0198-2022	—	open, classified	Packaged dental implant contains a different size then the size declared on the labeling.
Sep 23, 2021	Z-0197-2022	—	open, classified	Packaged dental implant contains a different size then the size declared on the labeling.
Oct 11, 2019	Z-1157-2020	—	terminated	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 severity varies based on a one or two stage surgery.
Oct 7, 2019	Z-1041-2020	—	terminated	Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.
Aug 9, 2019	Z-0364-2020	—	terminated	A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.
Jan 9, 2019	Z-1126-2020	—	terminated	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 labels were incorrect.Specifically, the color coded vial and cap does not match the implant size described on the vial. As a result of the incorrect color on the vial and cap, the surgeon may not be certain if the implant received was the correct size. This could result in a delay in surgery, risk of infection if the surgical site has to be closed up and a second round of anesthesia.
Nov 28, 2018	Z-0791-2020	—	completed	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.
Nov 28, 2018	Z-0790-2020	—	completed	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.
Oct 26, 2018	Z-0363-2020	—	terminated	packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.
Sep 6, 2018	Z-0261-2020	—	terminated	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 result in a delay for the patient.
Aug 8, 2018	Z-0018-2020	—	terminated	Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number.
Aug 7, 2018	Z-0010-2020	—	terminated	The incorrect device was packaged in the vial.
May 29, 2018	Z-0089-2019	—	terminated	Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.
May 18, 2018	Z-2376-2018	—	terminated	Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant
Mar 14, 2018	Z-1917-2018	—	terminated	The cap on the vial might be labeled with the incorrect part number but the main vial label is correct.
Jan 23, 2018	Z-0539-2018	—	terminated	InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized.
Jan 19, 2018	Z-1168-2018	—	terminated	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).
Jan 19, 2018	Z-1167-2018	—	terminated	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).
Nov 15, 2017	Z-0283-2018	—	terminated	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 diameter is too small. In addition, the 2.3mm guide was too large.
Oct 10, 2017	Z-0185-2018	—	terminated	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 sterilization compromised.
Jul 21, 2017	Z-0007-2018	—	terminated	The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.
Jun 26, 2017	Z-3115-2017	—	terminated	The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.
May 2, 2017	Z-2125-2017	—	terminated	Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification.
Mar 3, 2017	Z-2551-2018	—	terminated	The main vial label lists the incorrect part number, but the cap label is correct.
Dec 12, 2016	Z-1112-2017	—	terminated	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-leakage and a possible infection to the patient.
Nov 28, 2016	Z-0961-2017	—	terminated	Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top.
Nov 15, 2016	Z-1920-2018	—	terminated	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.
Jul 5, 2016	Z-2320-2016	—	terminated	Issue with design specification; oversized condition.
May 19, 2016	Z-2046-2016	—	terminated	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 crown fabrication.
Mar 4, 2016	Z-1267-2016	—	terminated	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.
Oct 28, 2015	Z-0396-2016	—	terminated	Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill.