FDA Registration
Active
🇺🇸 United States
ORTHO DENTAL LAB, LLC
Reg #: 3032193293
·
FEI: 3032193293
·
Expires 2026
Products
15
Proprietary Names
26
Establishment Types
4
Classifications
15
Registration Details
- Registration Name
- ORTHO DENTAL LAB, LLC
- Registration Number
- 3032193293
- FEI Number
- 3032193293
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1530 Antioch Pike
- City
- Antioch
- State
- TN
- ZIP
- 37013
- Country
- US
Regulatory Submissions
- 510(k) Number
- K212496
Owner / Operator
- Firm Name
- Ortho Dental Lab, LLC
- Operator Number
- 10091367
- Address
- 1530 Antioch Pike
- City
- Antioch
- State
- TN
- Postal Code
- 37013
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2024-09-07 |
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 2024-09-22 |
| Floss, Dental | JES | Class 1 | Dental | No | 2025-09-24 |
| Setter, Band, Orthodontic | ECR | Class 1 | Dental | No | 2025-09-24 |
| Heat Source For Bleaching Teeth | EEG | Class 1 | Dental | No | 2024-09-26 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2024-09-07 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2025-09-04 |
| Maintainer, Space Preformed, Orthodontic | DYT | Class 1 | Dental | No | 2025-08-20 |
| Eraser, Dental Stain | MAU | Class 1 | Dental | No | 2024-12-28 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2025-09-04 |
| Material, Impression | ELW | Class 2 | Dental | No | 2024-09-22 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2024-09-26 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2024-09-22 |
| Cleanser, Denture, Over The Counter | EFT | Class 1 | Dental | No | 2024-12-28 |
| Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile | NOB | Class 1 | Dental | No | 2025-09-24 |
Proprietary Names
SmileSet Nighttime Aligners
SmileSet All-Day Aligners
SmileSet Nighttime Clear Aligners
Ortho Aligner System
SmileSet Aligners
SmileSet Premium Handheld Water Flosser
SmileSet Water Flosser Replacement Tips
SmileSet Premium Floss Picks
SmileSet Aligner/Retainer Seater/Removal Tool
SmileSet Wireless Whitening Light
SmileSet Premium Whitening Kit
SmileSet Retainers
Impression Tray
SmileSet Impression Tray
SmileSet Night Guards
SmileSet Premium Whitening
SmileSet Premium Whitening Pen
SmileSet Premium Whitening Refill
SmileSet Premium Sensitive Whitening Strips
SmileSet Cheek Retractor
SmileSet Impression Kit
IMPRESSION KIT
SmileSet Premium Sonic Toothbrush
SmileSet Premium Sonic Toothbrush Refill Heads
SmileSet Premium Ultrasonic Cleaner + UV Sanitizer
SmileSet Universal Cleaning Tablets
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility