Data / Medical devices / United States / Ortho Dental Lab, LLC
Ortho Dental Lab, LLC: FDA-registered device maker in Antioch, TN, United States, 4 510(k) clearances
Ortho Dental Lab, LLC is registered with the FDA (registration 3032193293) in Antioch, TN, United States. It lists 15 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 16, 2022. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3032193293
- Address
- 1530 Antioch Pike, Antioch, TN, United States, 37013
- Owner or operator
- Ortho Dental Lab, LLC (10091367)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- September 7, 2024
- Registered through
- 2026
- Brand names listed
- IMPRESSION KIT, Impression Tray, Ortho Aligner System, SmileSet Aligner/Retainer Seater/Removal Tool, SmileSet Aligners, SmileSet All-Day Aligners, SmileSet Cheek Retractor, SmileSet Impression Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Sequential | NXC | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cleaner, Ultrasonic, Medical Instrument | FLG | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Cleanser, Denture, Over The Counter | EFT | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Eraser, Dental Stain | MAU | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Floss, Dental | JES | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Heat Source For Bleaching Teeth | EEG | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Maintainer, Space Preformed, Orthodontic | DYT | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Setter, Band, Orthodontic | ECR | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Toothbrush, Powered | JEQ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Unit, Oral Irrigation | EFS | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile | NOB | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| March 16, 2022 | K220726 | K Clear | NXC | Substantially Equivalent | Kline Europe GmbH | accessdata.fda.gov |
| November 4, 2021 | K212496 | Ortho Aligner System | NXC | Substantially Equivalent | Ortho Lab Services, LLC | accessdata.fda.gov |
| September 16, 2009 | K092319 | STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387 | ELW | Substantially Equivalent | Danville Materials, Inc. | accessdata.fda.gov |
| April 5, 2000 | K000629 | FLEXTIME | ELW | Substantially Equivalent | Heraeus Kulzer, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Cleaner, Ultrasonic, Medical Instrument
- All makers of Setter, Band, Orthodontic
- All makers of Positioner, Tooth, Preformed
- All makers of Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile
- All makers of Retractor, All Types
- All makers of Toothbrush, Powered
Updated March 16, 2022. 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.