Not currently registered with FDA under this name
Glenroe Technologies
Bradenton, FL, United States. Named as applicant on 9 dental 510(k) clearances between 1992 and 1998. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 91992–1998
- Markets registered in
- 318 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 3 markets
Where regulators' registries name Glenroe Technologies 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 | Glenroe Technologies | 9 clearances | 1992–1998 | Below |
| South Korea | MFDS | Manufacturer | GLENROE TECHNOLOGIESGlenroe Technologies | 16 | 2004–2005 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | GLENROE TECHNOLOGIES. | 2 | 2006–2006 | 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 Glenroe Technologies as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 24 Feb 1998 | K980053 | GLENROE CHAIN | ECI Orthodontic Elastic Band |
| 27 Jan 1995 | K945535 | GLENROE ORTHO-SIL | EGD Intraoral Dental Wax |
| 6 Jan 1994 | K924351 | GLENROE ELASTIBITE STIMULATOR | KMY Preformed Tooth Positioner |
| 24 Aug 1993 | K932920 | GLENROE PLASTIC BRACKET | DYW Orthodontic Plastic Bracket |
| 22 Jul 1993 | K931462 | GLENROE CHAIN | ECI Orthodontic Elastic Band |
| 27 Apr 1993 | K924140 | TUFF TIES | ECI Orthodontic Elastic Band |
| 8 Apr 1993 | K924139 | GLENROE ORTHO SEPS | ECI Orthodontic Elastic Band |
| 31 Mar 1993 | K924211 | EJECTOR | DYN Saliva Ejector Mouthpiece |
| 25 Nov 1992 | K924993 | GLENROE BAND SEATING CONTOURING INSTRUMENT | ECS Orthodontic Band Pusher |
Some of these clearances are listed with FDA today by another company: Five Star Orthodontic Laboratory & Supply, Inc. (4).
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.