Not currently registered with FDA under this name
Intra-Lock International, Inc.
Boca Raton, FL, United States. Named as applicant on 12 dental 510(k) clearances between 2002 and 2017. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 122002–2017
- Markets registered in
- 874 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 8 markets
Where regulators' registries name Intra-Lock International, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Intra-Lock International, Inc. | 12 clearances | 2002–2017 | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | Intra Lock International INCIntra-Lock International, Inc. | 30 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Intra-Lock International, Inc.INTRA-LOCK INTERNATIONAL, INC. · INTRA-LOCK, INTERNATIONAL, INC. | 23 | 2006–2018 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Intra-Lock International, Inc.Intra-Lock International Inc. · Intra-Lock International Inc · +1 | 14 | 2003–2006 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | INTRA - LOCK INTERNATIONAL | 4 | 2013–2013 | Pure Global AI |
| Australia | TGA | Manufacturer | Intra-Lock International Inc | 1 | 2019–2019 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | Intra-Lock International, INC. | 1 | 2013–2013 | Pure Global AI |
| Israel | AMAR | Manufacturer | Intra Lock International Inc | 1 | — | 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
510(k) clearances
Clearances on which FDA names Intra-Lock International, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 26 Oct 2017 | K171831 | Intra-Lock Bone Fixation System | DZL Intraosseous Fixation Screw |
| 20 Mar 2014 | K133613 | INTRA-LOCK DENTAL IMPLANTS | DZE Root-Form Endosseous Implant |
| 1 Aug 2013 | K130140 | INTRA-LOCK OP DENTAL IMPLANT | DZE Root-Form Endosseous Implant |
| 8 Aug 2011 | K111199 | INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 21 Apr 2011 | K103194 | INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM | DZE Root-Form Endosseous Implant |
| 21 May 2008 | K080598 | MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS | NHA Endosseous Dental Implant Abutment |
| 12 Oct 2007 | K070601 | MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 14 Oct 2005 | K050970 | MILO DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 22 Mar 2004 | K040205 | INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 23 Dec 2003 | K031322 | INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS | DZE Root-Form Endosseous Implant |
| 19 Dec 2002 | K021915 | TRANSITIONAL IMPLANTS | DZE Root-Form Endosseous Implant |
| 24 Jul 2002 | K021322 | ENDOSSOUS IMPLANTS | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: BioHorizons Implant Systems, Inc. (9).
Sources
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 of the most recent filing, which can be a US agent.