Not currently registered with FDA under this name
Lancer Orthodontics, Inc.
Vista, CA, United States. Named as applicant on 14 dental 510(k) clearances between 1990 and 2013. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 141990–2013
- Markets registered in
- 759 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 7 markets
Where regulators' registries name Lancer Orthodontics, 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 | Lancer Orthodontics, Inc. | 14 clearances | 1990–2013 | Below |
| Canada | Health Canada | Registration holder | LANCER ORTHODONTICS INC. | 26 | 2004–2015 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Lancer Orthodontics, Inc.Lancer Orthodontics Inc. · Lancer Orthodontics, Inc | 13 | 2003–2012 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Lancer Orthodontics Inc. | 10 | 2023–2023 | Pure Global AI |
| Australia | TGA | Manufacturer | Lancer Orthodontics | 4 | 2018–2019 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | LANCER ORTHODONTICS, INC.LANCER ORTHODONTICS INC. | 4 | 2011–2021 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | LANCER ORTHODONTICS INC | 2 | — | 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 Lancer Orthodontics, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 11 Apr 2013 | K122069 | STORM MINI SCREW | OAT Orthodontic Endosseous Implant |
| 22 Jun 2007 | K071192 | BLUGOO HD | ELW Impression Material |
| 19 Sep 2005 | K051552 | O.A.S.I. SYSTEM | DZE Root-Form Endosseous Implant |
| 11 Aug 1999 | K991481 | PARAGON | EJJ Amalgam Alloy |
| 29 Apr 1991 | K904090 | ORTHODONTIC BONDING ADHESIVE CONTROL | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 9 Nov 1990 | K904092 | LANCER ORIGINAL, SIERRA, GENERAL PURPOSE | EJF Orthodontic Metal Bracket |
| 7 Nov 1990 | K904093 | BUCCAL TUBE, BUCCAL ATTACHMENT | EJF Orthodontic Metal Bracket |
| 5 Nov 1990 | K904091 | TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO | EJF Orthodontic Metal Bracket |
| 2 Nov 1990 | K904094 | C.A.T.,SINTERLINE,NATURAL ARCH,MICROTWIN,BIOTORQUE | EJF Orthodontic Metal Bracket |
| 2 Nov 1990 | K904089 | PERMA MESH | EJF Orthodontic Metal Bracket |
| 6 Aug 1990 | K902075 | INTRIGUE CERAMIC BRACKET | NJM Orthodontic Ceramic Bracket |
| 30 Jul 1990 | K901958 | GUARDIAN SAFE BOW | DZB Orthodontic Extraoral Headgear |
| 30 Jul 1990 | K901957 | MUSTANG, C.A.T. | EJF Orthodontic Metal Bracket |
| 10 Apr 1990 | K900578 | SPORTS PACK ELASTICS | EJF Orthodontic Metal Bracket |
Some of these clearances are listed with FDA today by another company: Young Innovations Inc (1).
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.