FDA Registration Active 🇺🇸 United States

ORTHO ORGANIZERS, INC.

Reg #: 2081322 · FEI: 2081322 · Expires 2026
Products
40
Proprietary Names
395
Establishment Types
3
Classifications
40

Registration Details

Registration Name
ORTHO ORGANIZERS, INC.
Registration Number
2081322
FEI Number
2081322
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
800 King George Blvd, Suite 100
City
Savannah
State
GA
ZIP
31419
Country
US

Regulatory Submissions

510(k) Number
K980195

Owner / Operator

Firm Name
ORTHO ORGANIZERS , INC.
Operator Number
2081322
Address
800 King George Blvd, Suite 100, --
City
Savannah
State
GA
Postal Code
31419
Country
US
Correspondent
Nicole - Rajek

Products

Device Name Product Code
Handle, Instrument, Dental EJB
Headgear, Extraoral, Orthodontic DZB
Clasp, Preformed EHP
Maintainer, Space Preformed, Orthodontic DYT
Scaler, Periodontic EMN
Aligner, Sequential NXC
Toothbrush, Manual EFW
Positioner, Tooth, Preformed KMY
Bracket, Ceramic, Orthodontic NJM
Mirror, Mouth EAX
Agent, Polishing, Abrasive, Oral Cavity EJR
Applicator, Resin KXR
Instrument, Ligature Tucking, Orthodontic ECP
Bracket, Metal, Orthodontic EJF
Bracket, Plastic, Orthodontic DYW
Tape, Measuring, Rulers And Calipers FTY
Instruments, Dental Hand DZN
Tube, Orthodontic DZD
Band, Preformed, Orthodontic ECM
Plier, Orthodontic JEX
Strip, Polishing Agent EHM
Disk, Abrasive EHJ
Bur, Dental EJL
Band, Elastic, Orthodontic ECI
Clamp, Wire, Orthodontic ECN
Wax, Dental, Intraoral EGD
Material, Impression ELW
Aligner, Bracket, Orthodontic ECQ
Film, Radiographic IWZ
Pusher, Band, Orthodontic ECS
Retainer, Screw Expansion, Orthodontic DYJ
Tray, Impression, Preformed EHY
Mouthguard, Prescription MQC
Spring, Orthodontic ECO
Gauge, Depth, Instrument, Dental EIL
Cleanser, Denture, Over The Counter EFT
Setter, Band, Orthodontic ECR
Retractor, All Types EIG
Floss, Dental JES
Wire, Orthodontic DZC

Proprietary Names

Instrument Handle Interproximal Stripper and Blade Refill Extraoral Facebows Ball Clasps Multiple orthodontic clasps Reveal® Retainers ClassOne Classic Cement Spatula and Scaler ClassOne Classic Single Ended Scaler ORTHO KIT PROXY BRUSH TOOTHBRUSH INTERPROXIMAL BRUSH Clear Advantage material Carriere SLX 3D Clear Releasable Force Module Photographic Stainless Steel Mirrors Mirror PixSure Perfect Prophylaxis Paste Alpha-Pro Alpha-Pro Kids Pack Mini-Molds Ligature Directors Carriere Motion 3D Clear Class II Malocclusion Carriere Motion 3D Ruler Carriere® InfiNiTi Loops™ Size Selector Carriere Motion Pro Ruler STAINLESS STEEL LINGUAL DIRECT BOND CLEATS NITANIUM PALATAL EXPANDER Pinnacle LINGUAL BUTTONS CARRIERE SELF LIGATING BRACKET LINGUAL SHEATHS CLASSIC SERIES STAINLESS STEEL BRACKETS Maestro Brackets BITE GUIDE Micro Direct Bond Button NITANIUM ROTATOR EDGEWISE MINI-ELITE OPTI-MIM NICKEL-LITE BRACKETS ERUPTION APPLIANCE Bionic Carriere Motion 3D Class III Malocclusion Carriere SLX TruEase Bite Corrector Herbst Appliance Carriere Motion 3D Sidekick Bondable Hook Direct Bond Eyelet Masel Direct Bond Button Round Flat Base Carriere SLX 3D Carriere Motion 3D Colors Class II Malocclusion Direct Bond Retainer Weldable Lingual Button - Curved Nickel-Free Mini Twin Gold Eruption Appliance Direct Bond Lingual Button Carriere Motion Pro Bite Corrector TRANSFORCE LINGUAL BAR LINGUAL HOOK Direct Bond Eyelets BAND & BRACKET ASSEMBLY Weldable Buttons FIXED RETAINER LINGUAL CLEATS Solstice Brackets Aria Expressions Votion TruEase Rapid Palatal Expander LINGUAL LUGS LC Lingual Retainer Elite Brackets Aria Brackets Di-MIM Brackets Lotus Plus DS Tongue Tamers Direct Bond Buttons Carriere Motion 3D Class II Malocclusion Twin Force Bite Corrector LINGUAL EYELETS Falcon Instruments Archwire Markers Carriere SLX 3D EZ Twist Opener Tweezer Carriere SLX CFI Opening Tool ORTHODONTIC INSTRUMENTS Elastic Remover Elastic Attacher X7 Instruments BRACKET PLACEMENT/POSITIONER SLB Opening Tool Elastic Directors Explorer Lotus Plus® DS SLB Turn Key Nickle Free Direct Bond Buccal Tubes ELITE OPTI-MIM TUBES TruFit 2 Buccal Tubes BUCCAL TUBES AND ATTACHMENTS TruCast Mini Second Molar Bondable Buccal Tubes Crimpable Cross Tubes Crimpable Double Tubes BUCCAL TUBE TruEase Bondable Buccal Tubes ORTHODONTIC BANDS, LINGUAL ATTACHMENTS AND BUCCAL TUBES Maestro Buccal Tubes TruFit 2 Elite Band Assembly Andrews2 Band Assemblies BICUSPID BANDS TEMPRA BANDS MOLAR BANDS BANDS EPIC BANDS ACCUFIT BANDS Wire Cutter, Bracket Remover-Multip Carriere Motion Placer Choice Orthodontic Instruments Ligature Hemostat Carriere Double Ended Opener Tool Distal Bender ENDURA PLUS PLASTIC NIPPERS Twin Force Tool TruEase locking tool BAND REMOVER TRIUMPH INSTRUMENTS BRACKET REMOVER Galaxy NeoLucent Plus REVEAL® Bumper Sleeve Power Chain Orthodontic Elastics Clear Elastics Carriere Motion 3D Force 1 and Force 2 Elastics Masel Elastic Chain Ring-Ties Ortho Organizers Elastic Chain Patient Ties Rainbow Elastics Ligature Rotation Wedges ClassOne Natural Elastics O-Ties Mini-O-Ties Hollow Tubing Mini Unicycle Ligature Ties Carriere Motion Force 3 Elastics LIP BUMPER TUBING COVER UPS LATEX FREE ELASTICS LIGHT, MEDIUM, HEAVY Safari Amber Elastics MAGNUM FORCE CHAIN ELASTIC Lip Protector ELASTIC SEPARATORS ELASTOMERICS MAXI-TIE ELASTIC MINI-STICKS Elastic Thread UNICYCLE Elastics Amber Ligature Ties Separators Elast-o-loop Separators Elastics Neon Elast-o-loop2 Separators EXTRAORAL ELASTICS HAND-EE-LAST Extreme Chain Elastic Tube LIP GUARD Non-Latex Elastics BRACE COVER MINI STICKS LATEX INTRAORAL ELASTICS Safe-T-Ties K-2 MODULE ELASTICS LIGHT, MEDIUM, HEAVY WEDGES/MODULES COMFORT COVERS LATEX EXTRAORAL ELASTICS ROTATION WEDGES Elastic Chain Kissable Covers Safari Neon Elastics ELASTIC STICKS TISSUE GUARD Bulk Elastics MINI-TIE BULK LIGATURE TIES Natural Elastics Power Sticks CLEAR SOFT TUBING K-O MODULE Radiopaque Separators Ball Hook and Stop Henry Schein Split Surgical Ball Hook Crimpable Archwire Tube with Hook Split Rectangular Stop/Hook Micro Stops Crimpable Archwire Power Hook Split Surgical Ball Hook and Stop Split Universal Crimpable Ball Hook Clasps Arrowhead Clasps STOPS AND LOCKS Hooks Crimpable Bi-Directional Ball Hooks Ball Hook EZ Stops System Crimpable Archwire Hooks Crimpable Split Stops Crimpable Mini Stops Split Ball Hooks WRENCH Crimpable Ball Hooks Crimpable Archwire Stop GRIP-TIGHT LOCK Split Curved Hooks Silicone Patient Pack Elastobyte Wafers Relief Wafer Relief Wax Utility Wax Patient Relief Wax Laminated Bite Wafers Utility Wax Strips TASTES GREAT™ Alginate Flavoring Reflections Swivel Head Bracket Height Gauge Bracketizer (multiple) Deluxe Bracket Holder Tweezer Carriere Motion 3D Placement Instrument Buccal Tube Bonder Tweezer Bracket Placing Tweezer Direct Bond Bracket Holder BOONE GAUGE BRACKET POSITIONER/PLACER ZAND GAUGE TruVision Aligner Chewies Masel Band Pusher/Seater High Heat Bite Stick Band Seater Lombardi Bionator Bite Appliance Micro Sectional Expansor Upper Intraoral Appliances- Multiple Super Micro Expansor Super Micro Sectional Expansor Standard Expansor Expabent Expansion Screw Medium Expansor Vertical Arm Expansion Screw Safety Swivel Key Expansion Screws Reverse Pull Facemask NeoCrystal Plus PURE Composite Direct Bond Button OrthoFlex Composite Eyelet Bite-Builder OrthoFlex Composite Buttons Orthoflex Composite Brackets ClassOne Safety Release Modules Masel Safety Release Modules Multi-Adjustable Facemask Duralock Redi-Lock Sports Advantage material Carriere Motion Pro Clear Bite Corrector Anterior Torquing Spring Carriere® InfiNiTi Loops™ SEPARATORS CLOSED COIL SPRINGS OPENING SPRING DISTALIZING COIL SPRING DISTAL COIL SPRINGS STAINLESS STEEL SEPARATING SPRINGS Variable Coil Springs Nitanium Open Coil Springs Nickel Titanium Coil Springs SPRINGS Closed Coil Spring TruFlex Separating Springs Open Coil Spring Nickel Titanium Distalizing Springs Nitanium Force Springs CLOSED SPRINGS TruFlex Nickel Titanium TAD Closed Coil Springs PREFORMED COFFIN SPRINGS SEPARATING SPRINGS STAINLESS STEEL SPRINGS/PINS Bracket Height Gauge Doubled Ended Boone Gauge Aluminum Height Gauge High Heat Height Gauge Retainer Retriever ClassOne Facemask Protraction Facemask Ortho Organizers Cheek Retractors Tongue Shield High Heat Cheek Retractor Photo Cheek Retractors Masel Cheek Retractors Double Ended Lip Retractor Intraoral Cheek Retractors Extraoral Cheek Retractors High Pull Head Caps Cervical Neck Pads Dental Floss Flosser ECONOMY NITI ARCHWIRES REVERSE CURVE ARCHWIRE TruFlex Nickel Titanium Archwire TruFlex Copper Nickel Titanium Archwire Stainless Steel Coaxial Archwire Stainless Steel Standard Twist Archwires Masel Stainless Steel Ligature Wire Shorty Ligature Twists Nitanium Torqued Archwire M-Series Archwires ANDREWS2 ARCHWIRE Therma-A-Form Ultra Archwire NITANIUM ARCHWIRES CV SUPERFORCE ARCHWIRES SUPER ELASTIC NITANIUM ARCHWIRES REGENCY ULTRA THERM ARCHWIRE ELASTINOL - ORTHOCOSMETIC SPOOLED ARCHWIRE STAINLESS STEEL GOLD TONE ARCHWIRE Utility Archwire Kit BIO-TWIST ARCHWIRES NITANIUM SPOOLED ARCHWIRE CNA ARCHWIRES LABIAL ARCHWIRES NITINOL ARCHWIRES EIGHT STRAND ARCHWIRES SIX STRAND ARCHWIRE TruForce Stainless Steel Archwire FIXED LINGUAL CONTROLLED ARCH STAINLESS STEEL BRIGHT ARCHWIRE THREE STRAND ARCHWIRE TruForce Stainless Steel Twist Wire CTA NON-EXTRACTION ARCHWIRES Tooth Tone Ties TEMPERED SPRING Tooth Tone Coated Preformed Ligature Ties Stainless Steel Straight Lengths TruForce Retainer Wire ARCHWIRE RETAINER NITANIUM LOOPED ARCHWIRE Flat Titanium Dead-Soft Lingual Retainer Bondable Lingual Retainer VALUE BRAND OF NITI WIRE MESH AUSSIE STAINLESS STEEL WIRE NITANIUM MULTIFORCE ARCHWIRE TruForce Stainless Steel Preformed Ligature Ties TruForce Ties BETA III ARCHWIRES NITANIUM RCS ARCHWIRE CTA EXTRACTION ARCHWIRES BetaForce Beta Titanium Archwire CNA BETA III ARCHWIRES LIGATURE TIES PENTA ONE ARCHWIRES STAINLESS STEEL LOOPED ARCHWIRE Tooth Tone Coated Archwire NITANIUM COATED ARCHWIRES SUPER PLUS ARCHWIRE KOBY LIGATURE TIES STAINLESS STEEL COATED ARCHWIRE TRIPPLE TWIST ARCHWIRE Kobayashi Ties MICRO COATED BIO-KINETIX ARCHWIRE Straight Wire MDA FIXED APPLIANCE Regency Confidential Archwire STAINLESS STEEL MULTI-STRAND ARCHWIRE STRAIGHT ELASTINOL ARCHWIRES STAINLESS STEEL ARCHWIRE Braided Retainer Wire CNA Palatal Arch Ligature Wire PREFORMED LIGATURE TIE STAINLESS STEEL MULTI-STRAND ARCHWIRE MASILOY CHROME COBALT ARCHWIRES PREMIUM NITI ARCHWIRES STAINLESS STEEL MULTI-STRAND ARCHWIRE SPOOL Stainless Steel Spooled Ligature Wire BLACK TI ARCHWIRES KOBY TIE HOOKS NITANIUM STRAIGHT WIRE MDA WIRE STAINLESS STEEL POSTED WIRE Econo Nickel Titanium Archwires RETAINER ARCHWIRES

Establishment Types

Repack or Relabel Medical Device Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility