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
| Manufacturer | Envista Holdings CorporationVerified spec[1][2][3] |
|---|---|
| Parent company | Envista Holdings Corporation, Brea, CaliforniaVerified spec[1] |
| Country | United StatesVerified spec[2] |
| Headquarters | 3050 East Hillcrest Drive, Thousand Oaks, California, United StatesVerified spec[2] |
| Founded | Requires 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) |
| Ownership | Acquired in 2010 by Sybron Dental Specialties, then a Danaher subsidiary; the business subsequently became part of Envista HoldingsVerified spec[2][1] |
| Manufacturer-described indication | Presented as offering high-quality implant solutions within the Envista portfolio, sold directly to cliniciansManufacturer-reported[3][2] |
Overview
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.
| Number | Device | Holder | Date |
|---|---|---|---|
| K222211 | Implant Direct Dental Implant Systems Portfolio - MR Conditional | Implant Direct Sybron Manufacturing, LLC | 2023-02-02 |
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.
| Number | Device | Holder | Date |
|---|---|---|---|
| 873 device records | — | Implant 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
- [1]Envista Holdings Corporation — Annual Report on Form 10-K for the year ended 31 December 2025 — U.S. Securities and Exchange Commission (EDGAR), 2026. Accessed 2026-07-21.
- [2]About Us — Implant Direct — Implant Direct. Accessed 2026-07-21.
- [3]Specialty Products & Technology — Envista — Envista Holdings Corporation. Accessed 2026-07-21.