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, Anti-Snoring LRK
Band, Elastic, Orthodontic ECI
Indirect Bonding Tray QJJ
Positioner, Tooth, Preformed KMY
Bracket, Ceramic, Orthodontic NJM
Adhesive, Bracket And Tooth Conditioner, Resin DYH
Headgear, Extraoral, Orthodontic DZB
Sealant, Pit And Fissure, And Conditioner EBC
Wire, Orthodontic DZC
Agent, Tooth Bonding, Resin KLE
Maintainer, Space Preformed, Orthodontic DYT
Aligner, Sequential NXC
Coating, Filling Material, Resin EBD
Bracket, Metal, Orthodontic EJF
Resin, Denture, Relining, Repairing, Rebasing EBI
Powder, Porcelain EIH
Device, Jaw Repositioning LQZ
Spring, Orthodontic ECO
Material, Tooth Shade, Resin EBF
Retainer, Screw Expansion, Orthodontic DYJ
Clamp, Wire, Orthodontic ECN
Band, Material, Orthodontic DYO
Plier, Orthodontic JEX
Wax, Dental, Intraoral EGD

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