Registered with FDA
Fairfield Orthodontics, LLC
Stratford, CT, United States. Lists 8 dental device types with FDA across 1 registered establishment.
- Device types listed
- 8
- Brands and models
- 17
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Fairfield Orthodontics, LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Lister | SMILES CERAMIC BRACKETS | 2013 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Lister | NITI WIRESS WIRETIBEND WIRE | 2007 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Lister | ANCHOR BUCCAL TUBEFAIRFIELD BUCCAL TUBES | 2007 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | PERFORMA ADHEVISE | 2020 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Lister | ELASTICSELASTOMERIC TIESELASTOTIES | 2007 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Lister | BEST FIT MOLAR BANDSFAIRFIELD BANDSTITAN MOLAR BANDS | 2007 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Lister | GEM PLUS BRACKETSLP GEM BRACKETSSTRATUS BRACKETS | 2007 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Lister | PERFORMA INSTRUMENTS | 2007 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Fairfield Orthodontics, LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: HT Co., Ltd. (1), Cdb Corporation (1), Medental Intl. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 25 Jan 2011 | K102561 | ORTHODONTIC CERAMIC BRACKET | HT Co., Ltd. | NJM Orthodontic Ceramic Bracket |
| 7 Aug 2009 | K091702 | CDB FLIP-SIDE-CLIP BRACKET | Cdb Corporation | NJM Orthodontic Ceramic Bracket |
| 2 Apr 1999 | K990314 | MULTI-CURE COMPOSITE CEMENT | Medental Intl. | EBF Resin Tooth Shade Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| FAIRFIELD ORTHODONTICS, LLCFDA reg. 3006291983 | STRATFORD, CT, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9101523). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.