FDA Registration
Active
🇺🇸 United States
FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC.
Reg #: 1000118628
·
FEI: 1000118628
·
Expires 2026
Products
24
Proprietary Names
202
Establishment Types
3
Classifications
24
Registration Details
- Registration Name
- FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC.
- Registration Number
- 1000118628
- FEI Number
- 1000118628
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2928 Metro Street, Suite 102
- City
- Denton
- State
- TX
- ZIP
- 76207
- Country
- US
Regulatory Submissions
- 510(k) Number
- K973495
Owner / Operator
- Firm Name
- Five Star Orthodontic Laboratory & Supply, Inc.
- Operator Number
- 10033551
- Address
- 2928 Metro Street, Suite 102
- City
- Denton
- State
- TX
- Postal Code
- 76207
- Country
- US
- Correspondent
- John J Loch
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Anti-Snoring | LRK | Class 2 | Dental | No | 2013-12-16 |
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 2013-02-08 |
| Indirect Bonding Tray | QJJ | Class 1 | Dental | No | 2022-12-09 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2022-12-09 |
| Bracket, Ceramic, Orthodontic | NJM | Class 2 | Dental | No | 2013-02-08 |
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | Class 2 | Dental | No | 2016-09-23 |
| Headgear, Extraoral, Orthodontic | DZB | Class 2 | Dental | No | 2016-09-21 |
| Sealant, Pit And Fissure, And Conditioner | EBC | Class 2 | Dental | No | 2016-09-23 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2013-02-08 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2016-09-23 |
| Maintainer, Space Preformed, Orthodontic | DYT | Class 1 | Dental | No | 2022-12-09 |
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2023-02-10 |
| Coating, Filling Material, Resin | EBD | Class 2 | Dental | No | 2017-02-24 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2013-02-08 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2017-03-02 |
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2016-09-23 |
| Device, Jaw Repositioning | LQZ | Class 2 | Dental | No | 2021-08-19 |
| Spring, Orthodontic | ECO | Class 1 | Dental | No | 2013-02-08 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2016-09-23 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2022-12-09 |
| Clamp, Wire, Orthodontic | ECN | Class 1 | Dental | No | 2013-02-08 |
| Band, Material, Orthodontic | DYO | Class 1 | Dental | No | 2013-02-08 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2017-02-23 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2013-02-08 |
Proprietary Names
TAP III Anti-Snoring Device
DreamTAP
Indirect Bond
Positioner
Rely-A-Bond
Multi-Adjustable Face Mask
Fuji Ortho LC
Select Defense
Vivos DNA Appliance
Bi-Metric Distalizing Arch
Distal Jet Appliance
Niti Palatal Expander
Tandem Traction Bow
Rickonator
Three-Way Arnold
Unilateral K-Loop Distalizer
Fixed Spring 3-Way (D) - Upper
Frog Appliance
CD Distalizer
Sliding Spring Space Regainer
Herbst Mini Telescoping
Magill Sagittal
Crozat - Lower
Mara Appliance
Cantilever Herbst
Wilson Omega Adjustable Stops
Lower Fixed Crozat W/No Bands
Tongue Thrust Appliance
Anterior Growth Appliance
W-Arch Appliance
Jet Sagittal
Pendulum Appliance
Transverse Transforce
Bilateral K-Loop Distalizer
Nickel Titanium Expander
Wilson Multi-Action Palatal
Fixed Spring 3-Way (A) - Upper
Crozat - Upper
Controlled Arch
Bluegrass Appliance
Herbst Mini Telescoping Arm
Lip Bumper Appliance
Wilson Multi-Action Mandibular
Herbst Appliance
Transforce Sagittal
Alf
Wilson Multi-Action
Molar Rotator
Quad Helix
Crozat (Fixed) - Upper
Molar Uprighter
Myofunctional Tongue Thrust
Crozat (Fixed)- Lower
Thumb Sucking Appliance
Lingual E Arch
Anterior Growth/Jet Sagittal
Wilson 3D Lingual Arch
Primer
Transbond MIP
Transbond primer
Transbond lollypops
EZ Bond - Upper
Lingual Arch W/Omega
Transfer Tray
TPA/Nance Combo
Braided Lingual Retainer Wire
EZ Bond - Lower
Upper Lingual Arch
Lingual Arch - Lower
Transpalatal Arch
FLEA - Lower
Lower Lingual Arch
Removable Lingual Arch
Tri-Aligner
Pro Seal
Triad Gel
Vivos mRNA Appliance
Assure Universal Bonding Resin
Porcelain Etch
mmRNA
Self Cure Paste Tips
gel etch
LCR
Transbond LR
Transbond XT
Haas Appliance
Adult Split Bionator
Williams - Upper
Bondable R.P.E. - No Bands
Skeletal Expander
Pre Bio-Block
Jackson - Lower
Bilateral Leone Distalizer
Spring-Loaded Aligner
3X3 Bonded Lingual W/2 Pads
Gerber Finisher
Mini Bionator
Dual-Laminate Essix Upper
Bonded C.L.R. With Tray
Schwarz 3-Way - Upper W/Gear
Zendura Clear Retainer - Upper
Hawley- Lower
Barrel Sagittal
3X3 Bonded Lingual W/6 Pads
Five Star Mixed Dent Expander- Lower
Anterior Sagittal w/ S Bow
Spring Retainer 3X3 - Lower
Schwarz/Sagittal Combo - Upper
Orthopedic Corrector
Unilateral Expander
3X3 Banded Ling Ret W/Blank Ba
Schwarz/Sagittal Combo - Lower
FS-3-Way-Barrel
Five Star Fixed Expander - Upper
Activator
Aussie Wire 3X3
Ortho Finisher
Five Star Mixed Dent Expander- Upper
Hawley Spring Retainer - Lower
Wrap Around Hawley - Lower
Crown & Loop Space Maintainer
Schwarz - Lower W/Gear
Bite Plane W/Two Clasps - Upper
Han Appliance
Hawley- Upper
Twin Block
Bonded RPE
Spring Retainer 4X4 - Upper
Schwarz - Upper W/Gear
Sagittal - Lower W/Gear
Nord Crossbite
Bioliner Plus - Lower
E-Regainer - Upper
E-Regainer - Lower
Bionator
FS-Sagittal
FS-IPC-3-Way
FS-Distalizer
3-Way Anterior Sagittal w/ S Bow
Schwarz/E-Regainer Combo-Upper
Schwarz/E-Regainer Combo-Lower
FS 3-Way w/Memory Gear
Fixed Fan Gear Appliance
Memory RPE
Single Loop Space Maintainer
Super Screw Fixed Expander
FS-3-Way-Distalizer
Dual-Laminate Essix Lower
Spahl Split Verticle Appliance
Five Star Unilateral Distalizer - Lower
Class II Frankel
Essix Retainer - Upper
Zendura Clear Retainer - Lower
Bleaching Tray - Lower
Barrel Fixed Three-Way Appliance
Five Star Unilateral Distalizer - Upper
Compact RPE
Spring Retainer 3X3 - Upper
Pendex
Spring Loaded Anterior Sagittal w/ Locks
Bioliner Plus - Upper
Modified Class III Frankel
Mahoney Fixed 3-Way Appliance
Band & Loop Space Regainer
N-Sagittal
Distal Shoe Space Maintainer
Jackson - Upper
Bite Plane W/Two Clasps - Lower
3X3 Spring W/Ball Clasps
Hawley Spring Retainer - Upper
Five Star Bilateral Distalizer - Lower
Essix Retainer - Lower
Bleaching Tray - Upper
RPE
Williams - Lower
Schwarz W/Duo-T Springs - Lower
3X3 Braided Lingual Retainer
Unilateral Barrel Distalizer
Five Star Bilateral Distalizer - Upper
Wrap Around Hawley - Upper
Five Star Fixed Expander - Lower
Bilateral Barrel Distalizer
Schwarz Fan-Gear - Upper
Self-Activating Memory RPE
Post Finisher
Sagittal - Upper W/Gear
3-Way Schwarz W/Duo-T Springs
4X4 Bonded Lingual Retainer
Bonded C.L.R.
Spring Retainer 4X4 - Lower
Nance Appliance
Modified Williams
Pedo reverse pull facemask
Ultra Band Lok
Assure Plus
liquid etch
Fuji Ortho SC
Porcelain Conditioner
Elastic Mandibular Advancement (EMA)
Light Bond
Various Orthodontic Pliers
Face mask
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device
Manufacture Medical Device