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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2012-12-31 |
| Headgear, Extraoral, Orthodontic | DZB | Class 2 | Dental | No | 2013-01-09 |
| Clasp, Preformed | EHP | Class 1 | Dental | No | 2009-05-12 |
| Maintainer, Space Preformed, Orthodontic | DYT | Class 1 | Dental | No | 2022-11-10 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2018-01-16 |
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2023-01-05 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2009-07-24 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2008-06-19 |
| Bracket, Ceramic, Orthodontic | NJM | Class 2 | Dental | No | 2018-03-08 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2009-05-12 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2010-12-16 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 2012-12-31 |
| Instrument, Ligature Tucking, Orthodontic | ECP | Class 1 | Dental | No | 1992-06-09 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2016-11-28 |
| Bracket, Plastic, Orthodontic | DYW | Class 2 | Dental | No | 2016-11-28 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2022-08-03 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2012-12-27 |
| Tube, Orthodontic | DZD | Class 1 | Dental | No | 2005-03-25 |
| Band, Preformed, Orthodontic | ECM | Class 1 | Dental | No | 2005-03-25 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2005-04-20 |
| Strip, Polishing Agent | EHM | Class 1 | Dental | No | 2012-04-10 |
| Disk, Abrasive | EHJ | Class 1 | Dental | No | 2022-06-30 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2009-05-12 |
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 1995-08-10 |
| Clamp, Wire, Orthodontic | ECN | Class 1 | Dental | No | 2001-10-19 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2001-10-19 |
| Material, Impression | ELW | Class 2 | Dental | No | 2010-04-01 |
| Aligner, Bracket, Orthodontic | ECQ | Class 1 | Dental | No | 2009-05-12 |
| Film, Radiographic | IWZ | Class 1 | Radiology | No | 2025-09-02 |
| Pusher, Band, Orthodontic | ECS | Class 1 | Dental | No | 2017-06-29 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2001-10-19 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2001-10-19 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2025-09-02 |
| Spring, Orthodontic | ECO | Class 1 | Dental | No | 2005-04-20 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2008-06-18 |
| Cleanser, Denture, Over The Counter | EFT | Class 1 | Dental | No | 2012-12-31 |
| Setter, Band, Orthodontic | ECR | Class 1 | Dental | No | 2025-09-02 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2008-06-18 |
| Floss, Dental | JES | Class 1 | Dental | No | 2012-12-31 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2005-04-20 |
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