Manufacturer registered with FDA
Ortho Dental Lab, LLC
Antioch, TN, United States. Lists 14 dental device types with FDA across 1 registered establishment.
- Device types listed
- 14
- Brands and models
- 28
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Ortho Dental Lab, LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Impression MaterialELW · Class 2 | Impression materials | Lister | IMPRESSION KITSmileSet Impression Kit | 2024 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | Ortho Aligner SystemSmileSet AlignersSmileSet All-Day AlignersSmileSet Nighttime AlignersSmileSet Nighttime Clear Aligners | 2024 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | SmileSet Night Guards | 2025 |
| Orthodontic Band SetterECR · Class 1 | Dental hand instruments | Lister | SmileSet Aligner/Retainer Seater/Removal Tool | 2025 |
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Lister | SmileSet Premium Whitening KitSmileSet Wireless Whitening Light | 2024 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Lister | SmileSet Premium Handheld Water FlosserSmileSet Water Flosser Replacement Tips | 2024 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Lister | SmileSet Universal Cleaning Tablets | 2024 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Impression TraySmileSet Impression Tray | 2025 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Lister | SmileSet Cheek Retractor | 2025 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Lister | SmileSet Premium Sonic ToothbrushSmileSet Premium Sonic Toothbrush Refill Heads | 2024 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Lister | SmileSet Premium Floss Picks | 2025 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | SmileSet Retainers | 2024 |
| Dental Stain EraserMAU · Class 1 | — | Lister | SmileSet Premium Sensitive Whitening StripsSmileSet Premium WhiteningSmileSet Premium Whitening KitSmileSet Premium Whitening PenSmileSet Premium Whitening Refill | 2024 |
| Ultraviolet Sanitation/Sterilization (for Toothbrushes) Unit Non-SterileNOB · Class 1 | — | Lister | SmileSet Premium Ultrasonic Cleaner + UV SanitizerSmileSet Rechargeable Ultrasonic Cleaner + UV Sanitizer | 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
Ortho Dental Lab, LLC 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: Kline Europe GmbH (1), Ortho Lab Services, LLC (1), Danville Materials, LLC (1), Heraeus Kulzer, LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 16 Mar 2022 | K220726 | K Clear | Kline Europe GmbH | NXC Sequential Aligner |
| 4 Nov 2021 | K212496 | Ortho Aligner System | Ortho Lab Services, LLC | NXC Sequential Aligner |
| 16 Sep 2009 | K092319 | STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387 | Danville Materials, LLC | ELW Impression Material |
| 5 Apr 2000 | K000629 | FLEXTIME | Heraeus Kulzer, LLC | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ORTHO DENTAL LAB, LLCFDA reg. 3032193293 | Antioch, TN, United States | Complaint file establishment, Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10091367). 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.