Manufacturer registered with FDA
Selane Products, Inc.
Chatsworth, CA, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 7
- 510(k) clearances
- 22013–2017
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Devices listed with FDA
What Selane Products, 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 |
|---|---|---|---|---|
| Jaw Repositioning DeviceLQZ · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | ApnoDentATG/SM-OSA APPLIANCESClear Sleep | 2018 |
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | ApnoDentATG/SM-OSA APPLIANCESClear Sleep | 2018 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Lister | DigiLine Adirect Print Aligner System | 2025 |
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
Selane Products, 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: Park Dental Research Corp (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 5 Apr 2024 | K233935 | DigiLine Direct Print Aligner System | Park Dental Research Corp | NXC Sequential Aligner |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SPACE MAINTAINERS LABFDA reg. 2082148 | CHATSWORTH, CA, United States | Contract manufacturer, Manufacturer, Repacker / relabeler |
Other names on FDA records
Space Maintainers Lab
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9920085). 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.