Manufacturer registered with FDA
Aditek do Brasil SA
CRAVINHOS, Brazil. Lists 12 dental device types with FDA across 1 registered establishment.
- Device types listed
- 12
- Brands and models
- 46
- 510(k) clearances
- 0as applicant
- Markets registered in
- 7315 registrations outside the US
- Establishments
- 1Brazil
Registered in 7 markets
Where regulators' registries name Aditek do Brasil SA 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 | Aditek do Brasil SA | 12 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Aditek do Brasil SA | 281 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | ADITEK DO BRASIL SA | 19 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | ADITEK DO BRASIL S.A.ADITEK DO BRASIL LTDA. | 6 | 2016–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | ADITEK DO BRASIL LTDA | 4 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | ADITEK DO BRASIL LTDA.ADITEK DO BRASIL LTDA | 3 | 2007–2019 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ADITEK DO BRASIL, LTDAADITEK DO BRASIL, LTDA. | 2 | 2012–2015 | 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 Aditek do Brasil SA 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 | Maker | Active ClearActive Clear+BioCrystalEasyClip ClearSafiraSlide H5Translux | 2015 |
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Lister | — | 2017 |
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | Memoflex Copolyester; Memoflex PETG; Memoflex TPU | 2025 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | — | 2025 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Arcos BraidedArcos de AçoArcos de RetraçãoArcos Dupla ChaveArcos Nitinol super elasticoArcos TMAAtcos Nitinol Curva ReversaCoaxial WireFio AçoFio Elgiloy 7 moreFio TMAMola Nitinol abertaMola Nitinol de RetraçãoMola Nitinol DistalizaçãoNitinol Contour NitiNitinol termoativadoTwist Flex | 2013 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | TruSinter | 2007 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | ElastomericsIntraoral elasticsStick Tie | 2016 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | Niti Closed Coil SpringsNiti Closed Coil TAD SpringNiti Molar Distalizing SpringNiti Open Coil Springs | 2015 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Maker | EasyClip+ closing toolEasyClip+ opening tool | 2016 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Bite Turbo | 2026 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | BioClipBioClip PIBioMaxEasyClipEasyClip +One PieceVectorVector+Vector+ Biocross | 2007 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | Clear Aligner (EAB II) | 2025 |
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
Aditek do Brasil SA 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: Cdb Corporation (1), Forestadent Bernhard Forster GmbH (1), Scientific Pharmaceuticals (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 27 Sep 2016 | K160957 | CDB Self Ligating Bracket 8F | Cdb Corporation | NJM Orthodontic Ceramic Bracket |
| 5 Jun 2009 | K090933 | BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS | Forestadent Bernhard Forster GmbH | NJM Orthodontic Ceramic Bracket |
| 10 Aug 1979 | K791132 | SCI-PHARM ORTHODONTIC ADHESIVE | Scientific Pharmaceuticals | DYH Resin Bracket and Tooth Conditioner Adhesive |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ADITEK DO BRASIL, SAFDA reg. 3003622434 | CRAVINHOS Sao Paulo, Brazil | Contract manufacturer, Manufacturer, Private-label distributor, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9104741). 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.