Manufacturer registered with FDA
Implant Direct
Thousand Oaks, CA, United States. Lists 7 dental device types with FDA across 1 registered establishment, and holds 24 510(k) clearances as applicant.
- Device types listed
- 7
- Brands and models
- 37
- 510(k) clearances
- 242006–2023
- Markets registered in
- 8874 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 8 markets
Where regulators' registries name Implant Direct as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Implant Direct | 24 clearances | 2006–2023 | Below |
| Canada | Health Canada | Registration holder | IMPLANT DIRECT SYBRON MANUFACTURING LLC | 627 | 2003–2025 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Implant Direct Sybron Manufacturing, LLC. | 121 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | IMPLANT DIRECT SYBRON MANUFACTURING LLCIMPLANT DIRECT SYBRON MANUFACTURING, LLC. · IMPLANT DIRECT SYBRON MANUFACTURING LLC. | 62 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Implant Direct Sybron Manufacturing LLC | 27 | 2015–2025 | Pure Global AI |
| Colombia | INVIMA | Registration holder | IMPLANT DIRECT SYBRON MANUFACTURING LLCIMPLANT DIRECT SYBRON MANUFACTURING, LLC · IMPLANTDIRECT SYBRON MANUFACTURING, LLC. | 21 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Implant Direct Sybron Manufacturing LLCImplant Direct Sybron Manufacturing LLC. · Implant Direct Sybron Manufacturing, LLC. | 13 | 1999–2018 | Pure Global AI |
| Japan | PMDA | Registration holder | Ｉｍｐｌａｎｔ Ｄｉｒｅｃｔ Ｓｙｂｒｏｎ Ｍａｎｕｆａｃｔｕｒｉｎｇ， ＬＬＣＩｍｐｌａｎｔ Ｄｉｒｅｃｔ Ｓｙｂｒｏｎ Ｍａｎｕｆａｃｔｕｒｉｎｇ，ＬＬＣ | 3 | 2013–2016 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Implant Direct currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Custom Legacy and Custom InterActive Titanium AbutmentsInterActive SMARTBase AbutmentsInterActive/SwishPlus2 Implant SystemK060063K080713K090234Legacy Abutment SystemLegacy SMARTbase AbutmentsLegacy, GoDirect, RePlant, Simply Replant, ScrewIndirectLegacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts 5 moreReActive Dental Implant SystemSimply InterActiveSMARTbase Abutment SystemSpectra-System Abutments 2008: Legacy, RePlant, ScrewPlus, ScrewPlant, ScrewIndirectSwishPlant Dental Implant System | 2007 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | InterActive/SwishPlus2 Implant SystemK061319K080633K080713K090234Legacy, GoDirect, RePlant, Simply Replant, ScrewIndirectLegacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mountsReActive Dental Implant SystemScrewIndirect Dental ImplantsSIMPLY ICONIC Implants 3 moreSimply InterActiveSimply Legacy 3, Legacy3 6mm Length Implant SystemSpectra System: Legacy, RePlant, Simply Replant, ScrewIndirect | 2007 |
| Dental Abutment Design Software for Dental LaboratoryPNP · Class 2 | Dental design & orthodontic software | Maker | InterActive SMARTBase AbutmentsLegacy SMARTbase AbutmentsSMARTbase Abutment System | 2018 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Maker | Guided Surgery KitSurgical Drills | 2020 |
| All Precision AttachmentEGG · Class 1 | — | Maker | Ball Abutment Housing, Ball Abutment Nylon Liner, Ball Abutment Housing & Liner | 2025 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | Chairside bur block | 2018 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Implant Direct: Tooling, Hex DriverOEM: Stainless Steel Ratchet, 30Ncm Torque Wrench, Torque Wrench Multi-Setting, Stainless Steel Handle - Multiple | 2015 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Implant Direct as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 16 Aug 2023 | K231087 | Guided Surgery Kit | DZI Powered Bone Drill |
| 20 Jun 2023 | K223535 | SMARTbase Abutment System | NHA Endosseous Dental Implant Abutment |
| 2 Feb 2023 | K222211 | Implant Direct Dental Implant Systems Portfolio - MR Conditional | DZE Root-Form Endosseous Implant |
| 22 Jan 2021 | K201553 | Simply Iconic Implants | DZE Root-Form Endosseous Implant |
| 30 Jun 2020 | K200265 | Surgical Drills | DZI Powered Bone Drill |
| 25 Jun 2020 | K192221 | Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts | DZE Root-Form Endosseous Implant |
| 8 May 2020 | K192218 | Custom Legacy and Custom InterActive Titanium Abutments | NHA Endosseous Dental Implant Abutment |
| 10 Oct 2019 | K191458 | Legacy SMARTBase Abutments | NHA Endosseous Dental Implant Abutment |
| 15 Aug 2018 | K181359 | InterActive SMARTBase Abutments | NHA Endosseous Dental Implant Abutment |
| 24 Jul 2017 | K162633 | Custom Bars | NHA Endosseous Dental Implant Abutment |
| 26 Aug 2016 | K153509 | GPS Angled Abutment | NHA Endosseous Dental Implant Abutment |
| 16 Jul 2015 | K143011 | 2014 InterActive/SwishActive System | DZE Root-Form Endosseous Implant |
| 24 Dec 2013 | K130572 | INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 22 Aug 2013 | K131097 | LEGACY3 6MM LENGTH IMPLANTS | DZE Root-Form Endosseous Implant |
| 15 May 2009 | K090234 | SPECTRA SYSTEM DENTAL IMPLANTS 2008 | DZE Root-Form Endosseous Implant |
| 14 Jan 2009 | K081396 | SWISSPLANT DENTAL IMPLANT SYSTEM | NHA Endosseous Dental Implant Abutment |
| 14 Jan 2009 | K081101 | SPECTRA-SYSTEM ABUTMENTS 2008 | NHA Endosseous Dental Implant Abutment |
| 15 Jul 2008 | K080633 | SCREWINDIRECT DENTAL IMPLANTS | DZE Root-Form Endosseous Implant |
| 16 May 2008 | K080713 | REACTIVE DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 7 Mar 2008 | K073161 | REPLUS DENTAL IMPLANTS (HA) | DZE Root-Form Endosseous Implant |
| 13 Dec 2007 | K073049 | SCREWPLUS DENTAL IMPLANTS (HA) | DZE Root-Form Endosseous Implant |
| 10 Dec 2007 | K073033 | LEGACY DENTAL IMPLANTS | DZE Root-Form Endosseous Implant |
| 29 Sep 2006 | K061319 | SPECTRA SYSTEM | DZE Root-Form Endosseous Implant |
| 19 May 2006 | K060063 | LEGACY ABUTMENT SYSTEM | NHA Endosseous Dental Implant Abutment |
Some of these clearances are listed with FDA today by another company: Digital Age Dental Laboratories, Ltd. (2).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| IMPLANT DIRECT SYBRON MANUFACTURING LLCFDA reg. 3001617766 | Thousand Oaks, CA, United States | Manufacturer, Repacker / relabeler |
Other names on FDA records
Implant Direct Sybron Manufacturing, LLC.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9069060). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.