Manufacturer registered with FDA
Orthometric Ind. e Com. de Prod. Med. Odont.
Marília, Brazil. Lists 17 dental device types with FDA across 1 registered establishment.
- Device types listed
- 17
- Brands and models
- 71
- 510(k) clearances
- 0as applicant
- Markets registered in
- 22 registrations outside the US
- Establishments
- 1Brazil
Registered in 2 markets
Where regulators' registries name Orthometric Ind. e Com. de Prod. Med. Odont. 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 | Orthometric Ind. e Com. de Prod. Med. Odont. | 17 device types | — | Below |
| Egypt | EDA | Manufacturer | ORTHOMETRIC IND. E COM. DE PROD. MED. ODONT, | 2 | 2026–2026 | 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 Orthometric Ind. e Com. de Prod. Med. Odont. 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 Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | ICERAM CLEAR DISTALIZER | 2023 |
| Orthodontic Material BandDYO · Class 1 | Orthodontic wires & bands | Maker | ORTHOMETRIC BANDS | 2018 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | BIOVERSATIL ARCHWIRESFLEXY NiTi - ARCHWIRES KITFLEXY NiTi COPPER - CuNiTiFLEXY NiTi COPPER RHODIUMFLEXY NiTi REVERSE CURVEFLEXY NiTi SUPER ELASTICFLEXY NiTi SUPER ELASTIC RHODIUMFLEXY NiTi THERMO ACTIVELINEA ARCHWIRESORTHOMETRIC BETA FLEXY 10 moreORTHOMETRIC COLBOLOY - CrCoORTHOMETRIC RHODIUM ARCHWIRES SEQUENCEORTHOMETRIC SS - CrNiORTHOMETRIC SS - CrNi - BRAIDEDORTHOMETRIC SS - CrNi - BRAIDED RHODIUMORTHOMETRIC SS - CrNi - STRAIGHT WIREORTHOMETRIC SS - CrNi - WIRE FOR LIGATUREORTHOMETRIC SS CrNi RHODIUMORTHOMETRIC STRAIGHT WIRE BETA FLEXYSS ORTHOMETRIC ARCHWIRES KIT | 2018 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | ADVANCED SERIES TUBESBIOVERSATIL TUBESCAPELOZZA TUBESICERAM MINI TUBESLINEA TUBESMJANSON TUBESNANO TUBESPREMIUM SERIES TUBES | 2018 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | ORTHOMETRIC INSTRUMENTAL | 2022 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Lister | LEDX-PRO | 2023 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | ORTHOFLEXY ELASTOMERICORTHOMETRIC ELASTOMERICS - BLACK LATEXORTHOMETRIC ELASTOMERICS - CHAINORTHOMETRIC ELASTOMERICS - ELASTIC POSITIONERORTHOMETRIC ELASTOMERICS - EXTRA ORALORTHOMETRIC ELASTOMERICS - INTRA ORALORTHOMETRIC ELASTOMERICS - MODULAR LIGATUREORTHOMETRIC ELASTOMERICS - PACKING FOR PATIENTORTHOMETRIC ELASTOMERICS - SEPARATORORTHOMETRIC ELASTOMERICS - STICK LIGATURE 3 moreORTHOMETRIC ELASTOMERICS NON-LATEXSKY CHOICE ELASTIC CHAINSKY CHOICE PATIENT STICK TIES | 2018 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | ICERAM BUTTONLINEA STOPORTHOMETRIC LINGUAL BUTTONORTHOMETRIC STOPSTRAIGHT BALL POINT HOOKS | 2022 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | FLEXY NITI CLOSED SPRINGFLEXY NITI DISTALIZING OPEN SPRINGFLEXY NITI OPEN SPRING | 2022 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | ORTHOCHEWIE | 2023 |
| Articulation PaperEFH · Class 1 | — | Lister | ORTHOMETRIC ACETATE TRACING PAPER | 2022 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | ADVANCED SERIES BRACKETSBIOVERSATIL BRACKETSCAPELOZZA BRACKETSLINEA D2 BRACKETSORTHOMETRIC SMS BRACKETSPREMIUM ELITE BRACKETSPREMIUM SERIES BRACKETSU-CLIP BRACKETSULTRA-P BRACKETS | 2018 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | ORTHOMETRIC BUR | 2022 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Lister | ORTHOMETRIC PLIER | 2018 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | ORTHOMETRIC PRO ALIGNER X | 2022 |
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Maker | ICE CLEARICERAMICERAM-P | 2023 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Lister | SCANNER INTRAORAL IOS - DENTALINK | 2023 |
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
Orthometric Ind. e Com. de Prod. Med. Odont. 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: Orthometric - Industria E Comercio DE Produtos Medicos (1), Dentmate Technology Co. , Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 4 May 2023 | K222847 | Ceramic Brackets Orthometric | Orthometric - Industria E Comercio DE Produtos Medicos | NJM Orthodontic Ceramic Bracket |
| 3 Oct 2013 | K131042 | LEDEX | Dentmate Technology Co. , Ltd. | EBZ Ultraviolet Activator for Polymerization |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ORTHOMETRIC IND. E COM. DE PROD. MED. ODONT.FDA reg. 3013641573 | Marilia Sao Paulo, Brazil | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10056882). 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.