ORTHO ORGANIZERS, INC.

FDA Device Registration & Listing · Savannah, GA, US · Registration 2081322

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2081322
FEI Number
2081322
Entity Name
ORTHO ORGANIZERS, INC.
City/State/Country
Savannah, GA, US
Establishment Address
800 King George Blvd, Suite 100, Savannah, GA 31419, US
Establishment Type(s)
Repack or Relabel Medical Device,Manufacture Medical Device
Owner / Operator
ORTHO ORGANIZERS , INC. (Owner Number: 2081322)
Owner / Operator Contact Address
800 King George Blvd, Suite 100, --, Savannah, GA 31419, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K073045
PMA Number
N/A

All Registered 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 ORTHODONTIC INSTRUMENTS TruEase locking tool BAND REMOVER TRIUMPH INSTRUMENTS BRACKET PLACEMENT/POSITIONER BRACKET REMOVER Galaxy NeoLucent Plus REVEAL® Galaxy 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 Ball Clasps 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EJB Handle, Instrument, Dental Dental Class 1 872.4565 2012-12-31
DZB Headgear, Extraoral, Orthodontic Dental Class 2 872.5500 2013-01-09
EHP Clasp, Preformed Dental Class 1 872.3285 2009-05-12
DYT Maintainer, Space Preformed, Orthodontic Dental Class 1 872.5525 2022-11-10
EMN Scaler, Periodontic Dental Class 1 872.4565 2018-01-16
NXC Aligner, Sequential Dental Class 2 872.5470 2023-01-05
EFW Toothbrush, Manual Dental Class 1 872.6855 2009-07-24
KMY Positioner, Tooth, Preformed Dental Class 1 872.5525 2008-06-19
NJM Bracket, Ceramic, Orthodontic Dental Class 2 872.5470 2018-03-08
DZB Headgear, Extraoral, Orthodontic Dental Class 2 872.5500 2013-01-09
EAX Mirror, Mouth Dental Class 1 872.4565 2009-05-12
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2010-12-16
KXR Applicator, Resin Dental Class 1 872.3140 2012-12-31
ECP Instrument, Ligature Tucking, Orthodontic Dental Class 1 872.4565 1992-06-09
EJF Bracket, Metal, Orthodontic Dental Class 1 872.5410 2016-11-28
DYW Bracket, Plastic, Orthodontic Dental Class 2 872.5470 2016-11-28
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2022-08-03
EJF Bracket, Metal, Orthodontic Dental Class 1 872.5410 1995-08-10
DZN Instruments, Dental Hand Dental Class 1 872.4565 2012-12-27
DZD Tube, Orthodontic Dental Class 1 872.5410 2005-03-25
ECM Band, Preformed, Orthodontic Dental Class 1 872.5410 2005-03-25
JEX Plier, Orthodontic Dental Class 1 872.4565 2005-04-20
EHM Strip, Polishing Agent Dental Class 1 872.6010 2012-04-10
NJM Bracket, Ceramic, Orthodontic Dental Class 2 872.5470 2012-11-20
EHJ Disk, Abrasive Dental Class 1 872.6010 2022-06-30
EJL Bur, Dental Dental Class 1 872.3240 2009-05-12
ECI Band, Elastic, Orthodontic Dental Class 1 872.5410 1995-08-10
ECN Clamp, Wire, Orthodontic Dental Class 1 872.5410 2001-10-19
EGD Wax, Dental, Intraoral Dental Class 1 872.6890 2001-10-19
ELW Material, Impression Dental Class 2 872.3660 2010-04-01
NXC Aligner, Sequential Dental Class 2 872.5470 2023-01-18
EJF Bracket, Metal, Orthodontic Dental Class 1 872.5410 2007-11-13
ECQ Aligner, Bracket, Orthodontic Dental Class 1 872.4565 2009-05-12
IWZ Film, Radiographic Radiology Class 1 892.1840 2025-09-02
ECS Pusher, Band, Orthodontic Dental Class 1 872.4565 2017-06-29
DYJ Retainer, Screw Expansion, Orthodontic Dental Class 1 872.5410 2001-10-19
DZB Headgear, Extraoral, Orthodontic Dental Class 2 872.5500 2025-12-23
NJM Bracket, Ceramic, Orthodontic Dental Class 2 872.5470 2014-03-26

Official Correspondent

Nicole Rajek

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ORTHO ORGANIZERS , INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K851721 Artiberia 1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS 1985-07-02
K973236 Procter & Gamble Co. CREST TOOTHBRUSH WITH MICROSHIELD 1998-03-11
K180404 3M Healthcare 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System 2018-03-16
K121698 Dentsply International, Inc. NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN 2012-08-06
K894358 Ormco Corp. LUMINA ORTHODONTIC BRACKET 1989-09-15

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2012 Biomet Microfixation, Inc. 1
Biomet Microfixation outer packaging labeled in part:"REF: SP-2411***RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850***DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com***." Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04***Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USA***MediMark Europe BP2332 F-38033 Grenoble Cedex 2. France***LOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN***" Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2081322. Last updated year: 2026. Please use registration number 2081322 when referencing this establishment in official correspondence.
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