Data / Medical devices / United States / Beyond International Inc.
Beyond International Inc.: FDA-registered device maker in Sugar Land, TX, United States, 1 510(k) clearance
Beyond International Inc. is registered with the FDA (registration 3005791808) in Sugar Land, TX, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 18, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005791808
- Address
- 711 Julie Rivers Dr., Sugar Land, TX, United States, 77478
- Owner or operator
- Beyond International Inc. (10030042)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- August 3, 2009
- Registered through
- 2026
- Brand names listed
- BY-M015 BEYOND® FlexiPro Cheek Retractor (5 Pack), BY-M016 BEYOND® FlexiPro Cheek Retractor (Single Pack), InPulse Dental Laser
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dam, Rubber | EIE | 1 | Manufacturer | accessdata.fda.gov |
| Heat Source For Bleaching Teeth | EEG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| July 18, 2013 | K131805 | INPULSE LASER | GEX | Substantially Equivalent | Incisive, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Heat Source For Bleaching Teeth
- All makers of Dam, Rubber
- All makers of Retractor, All Types
- All makers of Powered Laser Surgical Instrument
Updated July 18, 2013. 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.