Manufacturer registered with FDA
TDV Dental Ltda
POMERODE, Brazil. Lists 14 dental device types with FDA across 1 registered establishment.
- Device types listed
- 14
- Brands and models
- 94
- 510(k) clearances
- 0as applicant
- Markets registered in
- 10277 registrations outside the US
- Establishments
- 1Brazil
Registered in 10 markets
Where regulators' registries name TDV Dental Ltda as the manufacturer or the registration holder of a device.
RegisteredHome: BrazilOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | TDV Dental Ltda | 14 device types | — | Below |
| Colombia | INVIMA | Registration holder | TDV DENTAL LTDA | 136 | — | Pure Global AI |
| Brazil | ANVISA | Registration holder | TDV DENTAL LTDA | 56 | 2000–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | TDV Dental Ltda | 30 | 2005–2024 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | TDV DENTAL LTDA | 26 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | TDV DENTAL LTDATDV DENTAL LTDA. | 11 | 2013–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | TDV DENTAL LTDA. | 11 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | TDV DENTAL LTDATDV Dental Ltda. · TDV Dental Ltda., | 4 | 2011–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | TDV DENTAL Ltda. | 2 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | TDV DENTAL LTDA | 1 | 2023–2023 | 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 TDV Dental Ltda currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | ANATOMIC WEDGESINTERDENTAL WEDGESSeptoWedgesTRANSLUCID WEDGES | 2006 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | Finishing and Polishing DiscsFinishing and Polishing Discs MandrelPRAXISPraxis MandrelSANDPAPER DISCSSeptoDiscsSeptoDiscs MandrelSUPERFIX | 2006 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | PROFILAXProphy Brushes | 2006 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Maker | ACRYL POLISHDIAMOND POLISH CERAM-CLINICDIAMOND POLISH CERAM-LABDIAMOND POLISH COMPO-CLINICDIAMOND POLISH ONE-STEPEXTRAPOL LABFIBERGLASSINTRAPOL CERAMINTRAPOL UNIVERSALMETAL POLISH 6 moreMETAL POLISH LABOPTIMIZEPOLISHING BRUSHPraxis DiamondPraxis PolishersSeptoPolisher | 2006 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | ABRASIVE STEEL STRIPAPPROXIMAL FINISHING SANDPAPERDIAMOND STRIPSeptoDiamond StripsSeptoFipo StripsSERRATED DIAMOND STRIPSuper-Snap Polystrips | 2006 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | MAXVIEW | 2008 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | Contact + GoldFOTOPLUSSeptoContactSeptoCure | 2006 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | ESTHETIC PLUSSeptoCompo Shape | 2006 |
| Polishing Agent WheelEJQ · Class 1 | Polishing & prophylaxis | Maker | FELT WHEELSIMPREGNATED FELT WHEELSPOLIFIXPOLIMAXPRAXIS POLISHPraxis ShineSeptoPlus MandrelSeptoWheels PXVersaplus Mandrel | 2006 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | DIAMOND GLOSSPOLIGLOSSSeptoDiamond Paste | 2006 |
| Operative Cutting InstrumentEKD · Class 1 | Dental hand instruments | Maker | MICROCUTMICROCUT MANUAL | 2006 |
| Operative Matrix Contouring InstrumentEKF · Class 1 | Dental hand instruments | Maker | CERVICAL MATRIXDECIDUOUS MATRICESIsoTapeMETALLIC MATRIX STRIPMETALLIC MOLAR MATRICESMETALLIC PREMOLAR MATRICESMOLAR MATRICESMOLAR STRIPPOLYSTER MATRIX STRIPPREMOLAR MATRICES 20 morePREMOLAR STRIPSeptoMatrix CervicalSeptoMatrix SectionalSeptoMatrix Sectional KitSeptoMatrix Sectional Refill - MatricesSeptoMatrix Sectional Refill - RingSeptoMatrix Sectional Refill - Triangular Silicone TipsSeptoTapeTOFFLEMIRE MATRIXUNIMATRIXUnimatrix PliersUNIMATRIX RUnimatrix R - Matrices RefillUnimatrix R - Ring RefillUnimatrix R - Triangular Silicone Tips RefillUnimatrix R KitUNIMATRIX SUnimatrix S - Matrices RefillUnimatrix S - Ring RefillUnimatrix S Kit | 2006 |
| Calculus Removal Hand InstrumentELA · Class 1 | Dental hand instruments | Maker | Prophylactic StripPROPHYLAXIS STRIPSeptoProphy Strips | 2008 |
| Preformed CrownELZ · Class 1 | — | Maker | ANTERIOR CROWNSDECIDUOUS CROWNSPOSTERIOR CROWNS | 2006 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| TDV DENTAL LTDAFDA reg. 9613208 | POMERODE Santa Catarina, Brazil | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9030432). 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.