Not currently registered with FDA under this name
Ortho Source
North Hollywood, CA, United States. Named as applicant on 11 dental 510(k) clearances between 1986 and 2007. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 111986–2007
- Markets registered in
- 319 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1980–2026
Registered in 3 markets
Where regulators' registries name Ortho Source 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 | Ortho Source | 11 clearances | 1986–2007 | Below |
| Colombia | INVIMA | Manufacturer | ORTHOSOURCEORTHOSOURCE, INC. | 18 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | ORTHOSOURCE | 1 | 2012–2012 | 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 Ortho Source as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 14 Feb 2007 | K061897 | EXCEL CONTRA ANGLE HANDPIECE | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 16 Aug 2006 | K061581 | EXCEL HIGH SPEED DENTAL HANDPIECE | EFA Dental Belt and/or Gear Driven Handpiece |
| 27 Aug 1992 | K913853 | FISSURE SEALER | EBC Pit and Fissure Sealant and Conditioner |
| 14 Jan 1992 | K913854 | ORTHO LIGHT CURE | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 19 Nov 1991 | K913519 | SUMO GLASS IONOMER CEMENT | EMA Dental Cement |
| 23 Feb 1989 | K884949 | VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER | EJK Calcium Hydroxide Cavity Liner |
| 3 Jan 1989 | K884575 | MAXIBOND | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 2 May 1986 | K861118 | ORTHOJOIN, ORTHODONTIC ADHESIVE | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 17 Apr 1986 | K861258 | PERMABAND (ORTHODONTIC ADHESIVE) | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 11 Apr 1986 | K861245 | ORTHOSOURCE ETCH SYSTEMS | EBC Pit and Fissure Sealant and Conditioner |
| 25 Mar 1986 | K860959 | DEPENDABOND | DYH Resin Bracket and Tooth Conditioner Adhesive |
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.