FDA Registration
Active
🇺🇸 United States
Ortho Solutions LC
Reg #: 1937100
·
FEI: 1937100
·
Expires 2026
Products
49
Proprietary Names
23
Establishment Types
3
Classifications
49
Registration Details
- Registration Name
- Ortho Solutions LC
- Registration Number
- 1937100
- FEI Number
- 1937100
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8050 Hawk Ridge Trail
- City
- Lake Saint Louis
- State
- MO
- ZIP
- 63367
- Country
- US
Regulatory Submissions
- 510(k) Number
- K192127
Owner / Operator
- Firm Name
- Ortho Solutions LC
- Operator Number
- 1937100
- Address
- 8050 Hawk Ridge Trail
- City
- Lake Saint Louis
- State
- MO
- Postal Code
- 63367
- Country
- US
- Correspondent
- MATTHEW - MALABEY
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2011-09-02 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2019-03-13 |
| Device, Anti-Snoring | LRK | Class 2 | Dental | No | 2023-06-29 |
| Disk, Abrasive | EHJ | Class 1 | Dental | No | 2018-09-06 |
| Guard, Disk | EEJ | Class 1 | Dental | No | 2018-02-08 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2011-09-02 |
| Maintainer, Space Preformed, Orthodontic | DYT | Class 1 | Dental | No | 2011-09-02 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2017-08-25 |
| Driver, Band, Orthodontic | ECT | Class 1 | Dental | No | 2011-09-02 |
| Aligner, Bracket, Orthodontic | ECQ | Class 1 | Dental | No | 2011-09-02 |
| Tester, Pulp | EAT | Class 2 | Dental | No | 2017-10-12 |
| Bracket, Ceramic, Orthodontic | NJM | Class 2 | Dental | No | 2014-04-23 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-04-16 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2018-01-22 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2011-09-02 |
| Floss, Dental | JES | Class 1 | Dental | No | 2016-06-14 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2016-02-05 |
| Strip, Polishing Agent | EHM | Class 1 | Dental | No | 2016-11-11 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2014-09-12 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2018-10-15 |
| Instrument, Diamond, Dental | DZP | Class 1 | Dental | No | 2016-11-11 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2019-03-13 |
| Zinc Oxide Eugenol | EMB | Class 1 | Dental | No | 2017-05-17 |
| Setter, Band, Orthodontic | ECR | Class 1 | Dental | No | 2011-09-02 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2017-08-25 |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | Class 1 | Ophthalmic | No | 2021-08-16 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2021-09-07 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2013-07-29 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2016-06-14 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2013-07-02 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-04-24 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2011-09-02 |
| Spring, Orthodontic | ECO | Class 1 | Dental | No | 2011-09-02 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 2019-03-13 |
| Tube, Orthodontic | DZD | Class 1 | Dental | No | 2011-09-02 |
| Band, Preformed, Orthodontic | ECM | Class 1 | Dental | No | 2011-09-02 |
| Device, Jaw Repositioning | LQZ | Class 2 | Dental | No | 2023-11-20 |
| Instrument, Ligature Tucking, Orthodontic | ECP | Class 1 | Dental | No | 2011-09-02 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2011-09-02 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 2014-04-03 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2017-08-04 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2018-04-13 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2011-09-02 |
| Band, Material, Orthodontic | DYO | Class 1 | Dental | No | 2011-09-02 |
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 2011-09-02 |
| Pusher, Band, Orthodontic | ECS | Class 1 | Dental | No | 2011-09-02 |
| Sleep Appliances With Patient Monitoring | PLC | Class 2 | Dental | No | 2023-11-20 |
| Clamp, Wire, Orthodontic | ECN | Class 1 | Dental | No | 2011-09-02 |
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2019-06-28 |
Proprietary Names
Respire Pink AT Series
DISK GUARD
Dyna Ice, Chill Spray, Ortho-Ice
Face Shields & Accessory, Surgical Apparel
TAP-3 & Elite
TAP-1
Respire Blue Series
Respire Pink Series
Norris Clear System
Mouth Guard
Photographic Mirror
KN95 and ACCESSORY, SURGICAL APPAREL
Respire Blue EF+; Respire Pink EF Micro
EMA
Respire Medical
DynaFlex Bonding Brushes
Respire Pink DeniTrac® Hard; Respire Pink DeniTrac® Hard/Soft
Dorsal Appliance
Adjustable Herbst
LISA II®
LISA®
EZ Align
Respire Pink Series-EF
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)