Data / Medical devices / United States / GLO Science, Inc.
GLO Science, Inc.: FDA-registered device maker in Garden Grove, CA, United States, 1 510(k) clearance
GLO Science, Inc. is registered with the FDA (registration 3008475975) in Garden Grove, CA, United States. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 2, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008475975
- Address
- 10871 Capital Ave, Garden Grove, CA, United States, 92843
- Owner or operator
- GLO Science, Inc. (10032735)
- Roles
- Complaint file establishment, Contract manufacturer, Specification developer
- First device listed
- June 14, 2010
- Registered through
- 2026
- Brand names listed
- GLO Control, GLO Dam, GLO Retractor, GLO Teeth Whitening Device Kit, Lammina Veneer, Six Month Smiles Aligner, Six Month Smiles PTK, Six Month Smiles Retainer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Sequential | NXC | 2 | Complaint file establishment | accessdata.fda.gov |
| Dam, Rubber | EIE | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Heat Source For Bleaching Teeth | EEG | 1 | Complaint file establishment, Contract manufacturer, Specification developer | accessdata.fda.gov |
| Indirect Bonding Tray | QJJ | 1 | Complaint file establishment | accessdata.fda.gov |
| Retainer, Screw Expansion, Orthodontic | DYJ | 1 | Complaint file establishment | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Teeth, Artificial, Backing And Facing | ELK | 1 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 2, 2021 | K210652 | 6MS Invisible Aligner | NXC | Substantially Equivalent | Sms Opco, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Retractor, All Types
- All makers of Heat Source For Bleaching Teeth
- All makers of Indirect Bonding Tray
- All makers of Aligner, Sequential
- All makers of Retainer, Screw Expansion, Orthodontic
- All makers of Teeth, Artificial, Backing And Facing
Updated June 2, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.