Manufacturer registered with FDA
Angelus Industria DE Produtos Odontologicos S/A
Londrina, Brazil. Lists 17 dental device types with FDA across 1 registered establishment, and holds 11 510(k) clearances as applicant.
- Device types listed
- 17
- Brands and models
- 58
- 510(k) clearances
- 112008–2021
- Markets registered in
- 15461 registrations outside the US
- Establishments
- 1Brazil
510(k) clearances per year, 2000–2026
Registered in 15 markets
Where regulators' registries name Angelus Industria DE Produtos Odontologicos S/A 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 | Angelus Industria DE Produtos Odontologicos S/A | 11 clearances | 2008–2021 | Below |
| Colombia | INVIMA | Registration holder | ANGELUS INDUSTRIA DE PRODUTOS ODONTOLOGICOS S/AANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS S/A · ANGELUS INDÚSTRIA DE PRODUTOS ODONTOLÓGICOS S/A | 280 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ANGELUS INDÚSTRIA DE PRODUTOS ODONTOLÓGICOS S/A | 95 | 2000–2026 | Pure Global AI |
| Canada | Health Canada | Registration holder | ANGELUS INDUSTRIA DE PRODUTOS ODONTOLOGICOS S/A | 16 | 2010–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | ANGELUS INDUSTRIA DE PRODUTOS ODONTOLOGICOS S/AANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS S/A · ANGELUS INDÚSTRIA DE PRODUTOS ODONTOLÓGICOS S/A | 15 | 2010–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Angelus Industria de Produtos Odontologicos S/A | 14 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ANGELUS INDUSTRIA DE PRODUTOS ODONTOLOGICOS S/AAngelus Indústria de Produtos Odontológicos S/A | 7 | 2015–2021 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Angelus Industria de Produtos Odontologicos S/A | 7 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | ANGELUS INDÚSTRIA DE PRODUTOS ODONTOLÓGICOS S/A | 5 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Angelus Industria de Produtos Odontologicos S/A | 5 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Angelus Industria de Produtos Odontologicos S/A | 5 | 2024–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Angelus Industria de Produtos Odontologicos S/A | 4 | 2010–2024 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | ANGELUS INDÚSTRIA DE PRODUTOS ODONTOLÓGICOS S/A | 4 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Angelus Industria de Produtos Odontologicos S/AAngelus Industria De Produtos Odontologicos S/A | 3 | 2010–2011 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Angelus Indústria de Produtos Odontológicos S/A | 1 | 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 Angelus Industria DE Produtos Odontologicos S/A currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Maker | BIO-C REPAIRBIO-C REPAIR ION+Bio-C SealerBIO-C SEALER ION+MTA - FillapexMTA ANGELUSMTA ANGELUS GreyMTA ANGELUS WhiteMTA Repair HPMTA-FILLAPEX | 2012 |
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | Flex Endodontic EjectorFlex Kids EjectorFlex Saliva EjectorFlex Surgical Ejector | 2013 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | STEEL DRILLS | 2026 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Interlig | 2017 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | E-FIBERPerma Fiber / Perma MeshPERMA MESH | 2017 |
| Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1 | — | Maker | METALPIN | 2009 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | KIDS TRIPLE SYRINGE - BLUEKIDS TRIPLE SYRINGE - PINK | 2013 |
| Articulation PaperEFH · Class 1 | — | Maker | CONTACTO ARCHCONTACTO FILMCONTACTO ORTOCONTACTO PAPER | 2009 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | Angie Prophy | 2015 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | AUTOCLAVABLE IMPRESSION TRAYMOLDEX 3 X 13D MOLDEX3D MOLDEX Bite | 2007 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | BIO-C SEALER TipsENDO TIPSMTA-FILLAPEX MIXING TIPSTriple Tips | 2009 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | ENDODONTIC RULERENDOMETRICINTERMEDIUMSILICON STOP | 2009 |
| Rubber Dam FrameEJE · Class 1 | Rubber dam systems | Maker | OSTBY FRAMERUBBER DAM FRAME | 2009 |
| Operative Amalgam CarrierEKI · Class 1 | Dental hand instruments | Maker | MTA ApplicatorSPEED GUN | 2013 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Nexis Endodontic Files | 2026 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | EXACTOEXACTO TAPEREXACTO TRANSLUCENTFIBER CAD POST & COREMICROPINNUCLEOJETPINJETREFORPINREFORPOST CARBON FIBERREFORPOST GLASS FIBER 3 moreREFORPOST METALLICREFORPOST MIXSPLENDOR | 2007 |
| Plaque Disclosing KitNYH · Class 2 | — | Maker | DISCLOSING AGENT | 2018 |
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 Angelus Industria DE Produtos Odontologicos S/A as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 11 Feb 2021 | K201222 | Bio-C Repair Ion+ | KIF Root Canal Filling Resin |
| 12 Dec 2019 | K190537 | BIO-C Sealer Ion+ | KIF Root Canal Filling Resin |
| 4 Jan 2019 | K180199 | BIO-C TEMP | KIF Root Canal Filling Resin |
| 31 Aug 2018 | K180185 | BIO-C REPAIR | KIF Root Canal Filling Resin |
| 4 Jan 2018 | K172701 | BIO-C SEALER | KIF Root Canal Filling Resin |
| 31 Aug 2016 | K151047 | MTA Repair HP | KIF Root Canal Filling Resin |
| 25 Apr 2014 | K140247 | MTA FILLAPEX | KIF Root Canal Filling Resin |
| 3 Jan 2014 | K132923 | FUSION SINGLE LINK | KLE Resin Tooth Bonding Agent |
| 31 May 2013 | K123823 | INTERLIG | EBF Resin Tooth Shade Material |
| 6 Jan 2012 | K112046 | MTA ANGELUS | KIF Root Canal Filling Resin |
| 17 Dec 2008 | K082180 | PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440 | EBI Rebasing Repairing Relining Denture Resin |
Some of these clearances are listed with FDA today by another company: HSG-S Corp (2), Peter Brasseler Holdings, LLC (1), Gebr. Brasseler GmbH & Co. KG (1).
Also lists devices cleared under other names
Angelus Industria DE Produtos Odontologicos S/A 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: Paxmed International (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 21 Aug 2012 | K113568 | MTA-FILLAPEX | Paxmed International | KIF Root Canal Filling Resin |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOSFDA reg. 3006542438 | LONDRINA Parana, Brazil | Foreign exporter, Manufacturer |
Other names on FDA records
Angelus Industria de Productos Odontologicos S/A
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9102422). 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.