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Implant Direct

Also known as: Implant Direct Sybron

A United States implant brand within Envista Holdings, built on a direct-to-clinician sales model and positioned in the value segment.

Key facts

ManufacturerEnvista Holdings CorporationVerified spec[1][2][3]
Parent companyEnvista Holdings Corporation, Brea, CaliforniaVerified spec[1]
CountryUnited StatesVerified spec[2]
Headquarters3050 East Hillcrest Drive, Thousand Oaks, California, United StatesVerified spec[2]
FoundedRequires manual verification(The company describes nearly 20 years of activity and the launch of its ScrewPlant system, but gives no explicit founding year on the pages we reached)
OwnershipAcquired in 2010 by Sybron Dental Specialties, then a Danaher subsidiary; the business subsequently became part of Envista HoldingsVerified spec[2][1]
Manufacturer-described indicationPresented as offering high-quality implant solutions within the Envista portfolio, sold directly to cliniciansManufacturer-reported[3][2]

Overview

Implant Direct was built on a straightforward commercial idea — sell implants directly to dentists rather than through a field sales force — which is why its prices sat well below the premium brands from the start. It was bought in 2010 by Sybron Dental Specialties, then part of Danaher, and travelled with the rest of Danaher’s dental businesses into Envista. Sharing an owner with Nobel Biocare does not make the two systems compatible; they remain separate product lines with separate connections. Some Implant Direct designs were deliberately made to accept components from other manufacturers’ platforms, so compatibility here is a product-by-product question rather than a brand-level one.

Regulatory record

Read this before drawing conclusions. A clearance or certificate means a device may legally be sold in a market. It is not a finding that the implant performs well, and it is not a comparison against other implants. In particular, FDA "clearance" is not FDA "approval" — clearance means the FDA accepted the device as substantially equivalent to one already on the market. What these actually mean →

FDA 510(k) clearance1 record

Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.

NumberDeviceHolderDate
K222211Implant Direct Dental Implant Systems Portfolio - MR ConditionalImplant Direct Sybron Manufacturing, LLC2023-02-02

Other1 record

Of 200 records we inspected, 156 are supplied sterile, 44 are supplied non-sterile and 0 do not state it. MRI safety labelling: Labeling does not contain MRI Safety Information (200). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.

NumberDeviceHolderDate
873 device recordsImplant Direct

Clearance records for Implant Direct were retrieved from the issuing authority's own database, not from the manufacturer's marketing material. We attribute a clearance to a brand only when the filing holder belongs to that brand's corporate family — third-party clearances for compatible components are excluded, because they belong to the company that made the component, not to Implant Direct.

Sources

Numbers match the citations beside each claim above.

Primary sources

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