Manufacturer registered with FDA
GLO Science, Inc.
New York, NY, United States. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name GLO Science, 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 | Manufacturer | GLO Science, Inc. | 7 device types | — | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | GLO SCIENCE LLC | 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
Devices listed with FDA
What GLO Science, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Lister | Six Month Smiles Retainer | 2024 |
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | GLO ControlGLO Teeth Whitening Device Kit | 2010 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | GLO Dam | 2019 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | GLO Retractor | 2019 |
| Backing and Facing Artificial TeethELK · Class 1 | — | Lister | Lammina Veneer | 2024 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Lister | Six Month Smiles Aligner | 2024 |
| Indirect Bonding TrayQJJ · Class 1 | — | Lister | Six Month Smiles PTK | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
GLO Science, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Sms Opco, LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 2 Jun 2021 | K210652 | 6MS Invisible Aligner | Sms Opco, LLC | NXC Sequential Aligner |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GLO Science, Inc.FDA reg. 3008475975 | Garden Grove, CA, United States | Complaint file establishment, Contract manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10032735). 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.