Data / Medical devices / United States / Space Maintainers Lab
Space Maintainers Lab: FDA-registered device maker in Chatsworth, CA, United States, 3 510(k) clearances
Space Maintainers Lab is registered with the FDA (registration 2082148) in Chatsworth, CA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 5, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2082148
- Address
- 9129 Lurline Ave, Chatsworth, CA, United States, 91311
- Owner or operator
- SELANE PRODUCTS, INC. (9920085)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- February 7, 2018
- Registered through
- 2026
- Brand names listed
- ATG/SM-OSA APPLIANCES, ApnoDent, Clear Sleep, DigiLine Adirect Print Aligner System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Sequential | NXC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Device, Anti-Snoring | LRK | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Device, Jaw Repositioning | LQZ | 2 | Contract manufacturer, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| April 5, 2024 | K233935 | DigiLine Direct Print Aligner System | NXC | Substantially Equivalent | Park Dental Research Corporation | accessdata.fda.gov |
| July 27, 2017 | K162816 | SML-OSA2 Appliances | LQZ | Substantially Equivalent | Selane Products, Inc. | accessdata.fda.gov |
| August 26, 2013 | K130130 | ATG/SM-OSA APPLIANCES | LQZ | Substantially Equivalent | Selane Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Jaw Repositioning
- All makers of Device, Anti-Snoring
- All makers of Aligner, Sequential
Updated April 5, 2024. 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.