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IMPLANT DIRECT SYBRON MANUFACTURING LLC

Last updated September 17, 2026

What IMPLANT DIRECT SYBRON MANUFACTURING LLC makes

Implant Direct Sybron Manufacturing LLC produces dental implant suprastructures, including permanent and temporary preformed abutments for single-use and multi-unit applications. Their portfolio also includes dental implant systems, fluted surgical drill bits, reusable surgical screwdrivers, drill guides, instrument trays, and animal-derived dental bone matrix implants. The company supplies reusable surgical instruments alongside implantable components designed for dental restoration procedures.

The company’s devices are classified under FDA categories Class I, Class II, and Unclassified (U), with all products listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to U.S. regulatory requirements for medical devices.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Implant Direct Sybron Manufacturing LLC primarily manufacture?

Implant Direct Sybron Manufacturing LLC specializes in dental implant-related devices. Their portfolio includes dental implant suprastructures like permanent and temporary preformed abutments, both for single-use and multi-unit applications. They also produce dental implant systems, reusable surgical tools such as fluted drill bits and screwdrivers, drill guides, instrument trays, and animal-derived dental bone matrix implants. These products are designed for dental restoration procedures, covering both implantable components and surgical instruments.

Where is Implant Direct Sybron Manufacturing LLC based, and how does this affect its devices?

Implant Direct Sybron Manufacturing LLC is based in the United States. This means their devices are subject to U.S. regulatory requirements, including classification under the FDA’s system. Since the company operates within the U.S., its products are designed and manufactured in compliance with FDA guidelines, ensuring they meet the necessary standards for safety, performance, and quality before entering the market.

Which regulatory registries list devices manufactured by Implant Direct Sybron Manufacturing LLC?

Devices manufactured by Implant Direct Sybron Manufacturing LLC are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is used to track and identify medical devices throughout their distribution and helps ensure transparency and traceability in the regulatory process. This listing is essential for compliance and allows healthcare providers, regulators, and other stakeholders to verify the identity of the devices.

How are the devices produced by Implant Direct Sybron Manufacturing LLC classified by the FDA?

The devices produced by Implant Direct Sybron Manufacturing LLC are classified under three FDA categories: Class I, Class II, and Unclassified (U). The classification depends on the risk associated with each device—Class I generally includes low-risk items like reusable surgical instruments, while Class II covers moderate-risk devices such as dental implant systems. Unclassified (U) devices are those that do not yet have a final classification assigned. This classification system helps determine the regulatory controls applied to ensure safety and effectiveness.

AI-generated from registry data and not verified by a human reviewer.

Information

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

Catalogue (3216)

Page 47 of 65

Device	Model / Reference	Registries	Class	Status
Swish™ Cover Screw	9037-01H	FDA UDI	Class II	Active
InterActive® Implant	663711	FDA UDI	Class II	Active
Simply Iconic™ Implant	673711NP	FDA UDI	Class II	Active
GoDirect® Implant	433708	FDA UDI	Class II	Active
simplyLegacy™ DRIVER	HD2.0SG	FDA UDI	Class I	Active
Legacy™ Healing Collar Concave Profile Narrow	8745-13N	FDA UDI	Class II	Active
ScrewPlant® Healing Collar Narrow	1047-13N	FDA UDI	Class II	Active
Straight Abutment Narrow	1047-21N	FDA UDI	Class II	Active
RePlus® Implant	714216	FDA UDI	Class II	Active
PEEK Replacement O-Ring for 2.7mmD Hex Tools (2 pieces)	PEEK-2.7	FDA UDI	Class I	Active
Simply Iconic™ / InterActive™ Angled Multi-Unit Abutment	6530-62-15S	FDA UDI	Class II	Active
Guided Surgery Handle Insert 3.4mmD	GS-3.4	FDA UDI	Class I	Active
Abutment Fixation Screw	1000-01	FDA UDI	Class II	Active
IMZ 4.0mm Titanium IME - 4mm Abutment	57-8288TU	FDA UDI	Class II	Active
UMA Titanium .050"/1.25mm Hex Screw	11-000052	FDA UDI	Class II	Active
Legacy™ Angled Multi-Unit Abutment	8530-62-15S	FDA UDI	Class II	Active
Swish™ Duo-Grip™ Healing Collar	9065-14H	FDA UDI	Class II	Unknown
Simply Iconic™ / InterActive™ SMARTbase Narrow, Non-Engaging	6530-82NNE	FDA UDI	Class II	Active
simply Legacy™2 Implant	825208U	FDA UDI	Class II	Active
Fixation Screw	1000-22	FDA UDI	Class II	Active
RePlant® Overdenture Abutment	6060-64	FDA UDI	Class II	Unknown
Legacy™ Straight Abutment	8530-21	FDA UDI	Class II	Active
ScrewPlus® Implant	213008	FDA UDI	Class II	Active
ScrewDirect® Implant	304716	FDA UDI	Class II	Active
Legacy™4 Implant	873716	FDA UDI	Class II	Active
RePlant® Implant	603508	FDA UDI	Class II	Active
Swish™ Countersink Drill	SPCD4.1	FDA UDI	Class II	Active
GPS® Bar Abutment-Short (1 piece)	2000-92S-1	FDA UDI	Class II	Active
RePlant® Ball Abutment	6035-74	FDA UDI	N/A	Unknown
Torque Wrench	TW	FDA UDI	Class I	Active
ScrewPlant® Implant	103711	FDA UDI	Class II	Active
30Ncm Torque Wrench	TW30	FDA UDI	Class I	Active
InterActive® Healing Collar	6534-12	FDA UDI	Class II	Active
ScrewPlant®/ ScrewPlus® Implant Analog	1057-06	FDA UDI	Class I	Active
Legacy™1 Implant	815716	FDA UDI	Class II	Active
Branemark Multi-Use RP Abutment 4.0mm	43-501040	FDA UDI	Class II	Active
Abutment Fixation Screw	1000-20B	FDA UDI	Class II	Active
InterActive® Abutment Removal Screw	AXS3.4	FDA UDI	Class I	Active
DIRECTguide™ Sleeve Regular	GSR	FDA UDI	Class I	Active
Multi-Unit Abutment Coping Screw	1000-25B	FDA UDI	Class II	Active
Legacy™ Implant Open-Tray Transfer	8057-08	FDA UDI	Class I	Active
Legacy™4 Implant	873706	FDA UDI	N/A	Unknown
Legacy™ Precision IO Scan Adapter	8735-09PT	FDA UDI	Class I	Active
Legacy™ Angled Abutment	8035-51	FDA UDI	Class II	Active
RePlus® Implant	713711	FDA UDI	Class II	Active
InterActive® Straight Contoured Abutment	6534-33	FDA UDI	Class II	Active
Swish™ Duo-Grip™ Cover Screw	9037-01H	FDA UDI	Class II	Active
SimplyIconic™InterActive™ Fixation Screw, NE	1000-52B	FDA UDI	Class II	Active
Steri-Oss 3.25 Non-Hex Flat Top Dalla Bona Male 1.0mm	48-343013	FDA UDI	Class II	Active
Dual-Grip™ Extra Long Fixation Screw (2 pieces)	1000-11XL	FDA UDI	Class II	Unknown

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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.

Implant Direct Sybron Manufacturing LLC has 33 recall records spanning from October 28, 2015, to May 1, 2025. The recalls include completed, open, classified, and terminated statuses, with reasons involving mispackaging, mislabeling, and incorrect component inclusion. Issues cited include wrong devices or parts being shipped, incorrect part numbers on labels, and discrepancies in drill kits or extender placements, as documented in the filed records.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

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.