Manufacturer registered with FDA
Ultimate Wireforms, Inc.
Bristol, CT, United States. Lists 4 dental device types with FDA across 2 registered establishments, and holds 6 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 13
- 510(k) clearances
- 61992–1996
- Markets registered in
- 1076 registrations outside the US
- Establishments
- 2Brazil, United States
510(k) clearances per year, 1990–2026
Registered in 10 markets
Where regulators' registries name Ultimate Wireforms, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Ultimate Wireforms, Inc. | 6 clearances | 1992–1996 | Below |
| European Union | EUDAMED | Manufacturer | Ultimate Wireforms, Inc. | 27 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Ultimate Wireforms, INC.Ultimate Wireforms, Inc. · ULTIMATE Wireforms, Inc. · +1 | 14 | 2002–2016 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | ULTIMATE WIREFORMS, INC.ULTIMATE DO BRASIL IMPORTACAO E EXPORTACAO LTDA. | 10 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | ULTIMATE WIREFORMS, INC | 9 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | ULTIMATE WIREFORMS INC | 5 | 2017–2017 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ULTIMATE WIREFORMS, INC.Ultimate Wireforms, Inc. | 4 | 2006–2016 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ULTIMATE DO BRASIL IMPORTAÇÃO E EXPORTAÇÃO LTDA | 3 | 2009–2014 | Pure Global AI |
| Australia | TGA | Manufacturer | Ultimate Wireforms Inc | 2 | 2022–2022 | Pure Global AI |
| Israel | AMAR | Manufacturer | Ultimate Wireforms, IncUltimate Wireforms, Inc. | 2 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Ultimate Wireforms, Inc. 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 WireDZC · Class 1 | Orthodontic wires & bands | Maker | Advanced ThermalBII-CNABlack-TiCTAGradient-3ORTHODONTIC ARCHWIREORTHODONTIC WIREUltra Therm | 2005 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | BUCCAL TUBEBUCCAL TUBESTUBE STOPS | 2005 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | ORTHODONTIC WIRE CLAMP | 2005 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | ORTHODONTIC SPRING | 2005 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Ultimate Wireforms, Inc. as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 9 May 1996 | K960799 | ORTHO-ICE | EAT Pulp Tester |
| 31 Mar 1993 | K924805 | ORTHODONTIC ARCH WIRE | DZC Orthodontic Wire |
| 31 Mar 1993 | K923837 | DIMPLED MULTI MODULUS ARCH WIRE | DZC Orthodontic Wire |
| 23 Dec 1992 | K923836 | .016' X .016 NICKEL TITANIUM UPRIGHTING SPRING | DZC Orthodontic Wire |
| 4 Dec 1992 | K923838 | THE ULTIMATE RCS ARCH WIRE | DZC Orthodontic Wire |
| 15 Oct 1992 | K923839 | NITINOL GENTLE TOUCH COIL SPRING | DZC Orthodontic Wire |
Some of these clearances are listed with FDA today by another company: Five Star Orthodontic Laboratory & Supply, Inc. (4).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ULTIMATE DO BRASIL IMPORTACAO E EXPORTACAO LTDA.FDA reg. 3005027553 | SAO JOSE DOS CAMPOS Sao Paulo, Brazil | Contract manufacturer |
| ULTIMATE WIREFORMS, INC.FDA reg. 1221844 | Bristol, CT, United States | Contract manufacturer, Manufacturer, Repacker / relabeler, Specification developer |
Other names on FDA records
Ultimate DO Brasil Importacao E Exportacao Ltda.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1221844). 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.