Data / Medical devices / United States / Fairfield Orthodontics, LLC
Fairfield Orthodontics, LLC: FDA-registered device maker in Stratford, CT, United States, 3 510(k) clearances
Fairfield Orthodontics, LLC is registered with the FDA (registration 3006291983) in Stratford, CT, United States. It lists 8 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 25, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006291983
- Address
- 410 Surf Avenue, Stratford, CT, United States, 06615
- Owner or operator
- FAIRFIELD ORTHODONTICS, LLC (9101523)
- Roles
- Repackager or relabeler
- First device listed
- May 14, 2007
- Registered through
- 2026
- Brand names listed
- ANCHOR BUCCAL TUBE, BEST FIT MOLAR BANDS, ELASTICS, ELASTOMERIC TIES, ELASTOTIES, FAIRFIELD BANDS, FAIRFIELD BUCCAL TUBES, GEM PLUS BRACKETS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Band, Elastic, Orthodontic | ECI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Band, Preformed, Orthodontic | ECM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bracket, Ceramic, Orthodontic | NJM | 2 | Repackager or relabeler | accessdata.fda.gov |
| Bracket, Metal, Orthodontic | EJF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tube, Orthodontic | DZD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | 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 |
|---|---|---|---|---|---|---|
| January 25, 2011 | K102561 | ORTHODONTIC CERAMIC BRACKET | NJM | Substantially Equivalent | Ht Co., Ltd. | accessdata.fda.gov |
| August 7, 2009 | K091702 | CDB FLIP-SIDE-CLIP BRACKET | NJM | Substantially Equivalent | Cdb Corporation | accessdata.fda.gov |
| April 2, 1999 | K990314 | MULTI-CURE COMPOSITE CEMENT | EBF | Substantially Equivalent | Medental Intl. | accessdata.fda.gov |
Compare with other makers
- All makers of Bracket, Metal, Orthodontic
- All makers of Bracket, Ceramic, Orthodontic
- All makers of Band, Elastic, Orthodontic
- All makers of Material, Tooth Shade, Resin
- All makers of Wire, Orthodontic
- All makers of Band, Preformed, Orthodontic
Updated January 25, 2011. 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.