FDA Registration
Active
🇺🇸 United States
RPE
Reg #: 1000118628
·
FEI: 1000118628
·
Expires 2025
Products
1
Proprietary Names
107
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC.
- Registration Number
- 1000118628
- FEI Number
- 1000118628
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2928 Metro Street, Suite 102
- City
- Denton
- State
- TX
- ZIP
- 76207
- Country
- US
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 |
|---|---|---|---|---|---|
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2022-12-09 |
Proprietary Names
RPE
Schwarz 3-Way - Upper W/Gear
Williams - Lower
Bleaching Tray - Upper
Bionator
FS-Sagittal
Five Star Fixed Expander - Upper
Adult Split Bionator
Wrap Around Hawley - Lower
Memory RPE
Crown & Loop Space Maintainer
Compact RPE
Five Star Bilateral Distalizer - Lower
Five Star Mixed Dent Expander- Upper
Essix Retainer - Lower
Schwarz/E-Regainer Combo-Lower
Nord Crossbite
Orthopedic Corrector
Zendura Clear Retainer - Upper
Hawley- Lower
Schwarz W/Duo-T Springs - Lower
Bilateral Barrel Distalizer
Five Star Unilateral Distalizer - Upper
Hawley- Upper
Pre Bio-Block
Bilateral Leone Distalizer
Spring-Loaded Aligner
3X3 Bonded Lingual W/2 Pads
Five Star Unilateral Distalizer - Lower
Class II Frankel
Williams - Upper
Activator
Jackson - Lower
Pendex
Post Finisher
Spring Loaded Anterior Sagittal w/ Locks
3X3 Bonded Lingual W/6 Pads
Band & Loop Space Regainer
Mahoney Fixed 3-Way Appliance
Five Star Mixed Dent Expander- Lower
3-Way Anterior Sagittal w/ S Bow
Aussie Wire 3X3
Spring Retainer 4X4 - Upper
Unilateral Barrel Distalizer
FS-Distalizer
Hawley Spring Retainer - Upper
Ortho Finisher
Self-Activating Memory RPE
Spring Retainer 3X3 - Upper
Bondable R.P.E. - No Bands
E-Regainer - Upper
E-Regainer - Lower
Single Loop Space Maintainer
Super Screw Fixed Expander
Bioliner Plus - Upper
Modified Class III Frankel
Twin Block
Barrel Sagittal
N-Sagittal
Jackson - Upper
Bite Plane W/Two Clasps - Lower
3X3 Spring W/Ball Clasps
Dual-Laminate Essix Upper
Spring Retainer 4X4 - Lower
FS-IPC-3-Way
Five Star Bilateral Distalizer - Upper
Wrap Around Hawley - Upper
Unilateral Expander
3X3 Banded Ling Ret W/Blank Ba
Bonded C.L.R.
FS-3-Way-Barrel
Barrel Fixed Three-Way Appliance
Fixed Fan Gear Appliance
Schwarz Fan-Gear - Upper
Hawley Spring Retainer - Lower
Zendura Clear Retainer - Lower
Schwarz/E-Regainer Combo-Upper
Schwarz - Lower W/Gear
Spring Retainer 3X3 - Lower
Sagittal - Lower W/Gear
Schwarz/Sagittal Combo - Upper
Bioliner Plus - Lower
FS-3-Way-Distalizer
Bonded RPE
Dual-Laminate Essix Lower
Spahl Split Verticle Appliance
Schwarz - Upper W/Gear
Bite Plane W/Two Clasps - Upper
Han Appliance
Skeletal Expander
3X3 Braided Lingual Retainer
Schwarz/Sagittal Combo - Lower
Bonded C.L.R. With Tray
Distal Shoe Space Maintainer
Nance Appliance
Modified Williams
Essix Retainer - Upper
Bleaching Tray - Lower
Haas Appliance
3-Way Schwarz W/Duo-T Springs
4X4 Bonded Lingual Retainer
Anterior Sagittal w/ S Bow
Five Star Fixed Expander - Lower
FS 3-Way w/Memory Gear
Sagittal - Upper W/Gear
Gerber Finisher
Mini Bionator
Establishment Types
Manufacture Medical Device