Data / Medical devices / United States / Ortho Organizers, Inc.
Ortho Organizers, Inc.: FDA-registered device maker in Savannah, GA, United States, 15 510(k) clearances
Ortho Organizers, Inc. is registered with the FDA (registration 2081322) in Savannah, GA, United States. It lists 40 device types. The FDA files 15 510(k) clearances under its listings, the newest dated November 27, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2081322
- Address
- 800 King George Blvd, Suite 100, Savannah, GA, United States, 31419
- Owner or operator
- ORTHO ORGANIZERS, INC. (2081322)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- June 9, 1992
- Registered through
- 2026
- Brand names listed
- ACCUFIT BANDS, ANDREWS2 ARCHWIRE, ARCHWIRE RETAINER, AUSSIE STAINLESS STEEL WIRE, Aligner Chewies, Alpha-Pro, Alpha-Pro Kids Pack, Aluminum Height Gauge and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Aligner, Bracket, Orthodontic | ECQ | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Aligner, Sequential | NXC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Applicator, Resin | KXR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Band, Elastic, Orthodontic | ECI | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Band, Preformed, Orthodontic | ECM | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bracket, Ceramic, Orthodontic | NJM | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bracket, Metal, Orthodontic | EJF | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bracket, Plastic, Orthodontic | DYW | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Clamp, Wire, Orthodontic | ECN | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Clasp, Preformed | EHP | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cleanser, Denture, Over The Counter | EFT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Disk, Abrasive | EHJ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Film, Radiographic | IWZ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Floss, Dental | JES | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gauge, Depth, Instrument, Dental | EIL | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Headgear, Extraoral, Orthodontic | DZB | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Ligature Tucking, Orthodontic | ECP | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Maintainer, Space Preformed, Orthodontic | DYT | 1 | Specification developer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pusher, Band, Orthodontic | ECS | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Retainer, Screw Expansion, Orthodontic | DYJ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scaler, Periodontic | EMN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Setter, Band, Orthodontic | ECR | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Spring, Orthodontic | ECO | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Strip, Polishing Agent | EHM | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Specification developer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tube, Orthodontic | DZD | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 27, 2025 | K252760 | Carriere® Motion Pro® Clear Bite Corrector | DYW | Substantially Equivalent | Ortho Organizers, Inc. | accessdata.fda.gov |
| June 4, 2021 | K210613 | HIT Clear Aligner | NXC | Substantially Equivalent | Cdb Corporation | accessdata.fda.gov |
| January 5, 2021 | K202857 | ClearPath Aligner | NXC | Substantially Equivalent | Clearpath Orthodontics, Ltd. | accessdata.fda.gov |
| March 8, 2018 | K173440 | Carriere SLX 3D Clear | NJM | Substantially Equivalent | Ortho Organizers, Inc. | accessdata.fda.gov |
| November 28, 2016 | K160720 | Carriere Motion Clear Class II | DYW | Substantially Equivalent | Ortho Organizers, Inc. | accessdata.fda.gov |
| May 19, 2011 | K110335 | CERAMIC BRACKETS | NJM | Substantially Equivalent | Ortho Organizers, Inc. | accessdata.fda.gov |
| December 18, 2007 | K073045 | SAPPHIRE CERAMIC BRACKET | NJM | Substantially Equivalent | Ortho Technology, Inc. | accessdata.fda.gov |
| June 9, 2000 | K000358 | MULTI ADJUSTABLE FACE MASK | DZB | Substantially Equivalent | Ortho Technology | accessdata.fda.gov |
| April 6, 1998 | K980151 | RELEASABLE FORCE MODULE | DZB | Substantially Equivalent | Ortho Kinetics Corp. | accessdata.fda.gov |
| March 11, 1998 | K980195 | FACEBOW | DZB | Substantially Equivalent | Ortho Kinetics Corp. | accessdata.fda.gov |
| November 21, 1997 | K973776 | REFLECTIONS | DYW | Substantially Equivalent | Cdb Corp. | accessdata.fda.gov |
| July 10, 1996 | K961754 | SAFETY RELEASE MODULE | DZB | Substantially Equivalent | G & H Wire Co. | accessdata.fda.gov |
| March 10, 1994 | K940410 | NEW GEAR RELEASABLE HEADGEAR | DZB | Substantially Equivalent | Ortho Kinetics Corp. | accessdata.fda.gov |
| February 25, 1994 | K940120 | ALPHA-DENT | ELW | Substantially Equivalent | Wallace A. Erickson & Co. | accessdata.fda.gov |
| July 30, 1992 | K922499 | REFLECTIONS - CERAMIC DENTAL BRACKET | EJF | Substantially Equivalent | Cdb Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 2, 2019 | 85468 | Class II | Terminated | Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484 | Orthodontic Bracket is mislabeled | accessdata.fda.gov |
| November 1, 2010 | 57587 | Not yet classified | Terminated | ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number (NF DB UR 6 Convertible.018-14T 14DO HK-Each); ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number, NF DB UL 6 Convertible.018-14T 14DO HK-Each; | Products were mis-labeled as nickel free. | accessdata.fda.gov |
Compare with other makers
- All makers of Positioner, Tooth, Preformed
- All makers of Film, Radiographic
- All makers of Instruments, Dental Hand
- All makers of Clamp, Wire, Orthodontic
- All makers of Maintainer, Space Preformed, Orthodontic
- All makers of Scaler, Periodontic
Updated November 27, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.