Manufacturer registered with FDA
Johns Dental Lab
Terre Haute, IN, United States. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 11
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Johns Dental Lab currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | Elastic Mandibular Advancement (EMA) applianceEMA 3DVivos DNAVivos mmRNAVivos mRNA | 2018 |
| Jaw Repositioning DeviceLQZ · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | EMA 3DVivos DNAVivos mmRNA | 2022 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | RedlineRedline Clear Aligner System | 2022 |
| Indirect Bonding TrayQJJ · Class 1 | — | Maker | Indirect Bonding Tray | 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
Johns Dental Lab 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: Johns Dental Laboratories (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 9 Feb 2022 | K213297 | Redline | Johns Dental Laboratories | NXC Sequential Aligner |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| JOHNS DENTAL LABORATORYFDA reg. 3014680794 | Terre Haute, IN, United States | Contract manufacturer, Manufacturer |
Other names on FDA records
Johns Dental Laboratory
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10058109). 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.