Is this your brand? Sign in to claim ownership.
Sign in to claim this brandTDV DENTAL LTDA
US
Last updated May 23, 2026
What TDV DENTAL LTDA makes
TDV Dental Ltda manufactures single-use and reusable dental instruments, including transparent crown moulds, cervical and molar matrix bands, abrasive discs and strips for tooth preparation, and interproximal reduction tools. Their portfolio also covers reusable dental spatulas, mandrels for abrasive applications, and polyester matrix strips used in restorative procedures.
All devices are classified as Class I under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable U.S. regulatory requirements for dental instruments.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of dental devices does TDV Dental Ltda manufacture?
TDV Dental Ltda specializes in dental instruments primarily used in restorative procedures. Their portfolio includes single-use items like dental abrasive discs, matrix bands (such as cervical and molar matrices), abrasive strips, and dental wedges. They also produce reusable tools, including dental spatulas, abrasive discs, mandrels (like the VERSAPLUS MANDREL), and polyester matrix strips. Additionally, they manufacture transparent crown moulds, which are used for shaping dental restorations.
Where is TDV Dental Ltda based, and what regulatory requirements do they follow?
TDV Dental Ltda is based in the United States. Since their devices are manufactured and sold there, they must comply with U.S. regulatory standards, including those set by the FDA. Their products are designed to meet the requirements for dental instruments under applicable U.S. regulations, ensuring safety and performance for clinical use.
Which regulatory registries or databases list TDV Dental Ltda’s devices?
TDV Dental Ltda’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, allowing them to verify device details such as manufacturer information, model names, and regulatory classification. Listing in the UDI database is a requirement for Class I devices under FDA regulations.
How are TDV Dental Ltda’s devices classified under FDA regulations?
All of TDV Dental Ltda’s devices are classified as Class I under FDA regulations. This classification applies to low-risk dental instruments, including moulds, abrasive tools, and reusable spatulas, which generally pose minimal risk to patients when used as intended. Class I devices typically require less stringent premarket review but must still meet performance and safety standards.
What is the purpose of devices like the TRANSPARENT CROWNS or UNIMATRIX in dental procedures?
Devices like TRANSPARENT CROWNS and UNIMATRIX are used in dental restorative procedures to shape and form dental fillings or crowns. Transparent crown moulds provide a clear template for preparing tooth structures, ensuring precise fit and contour for composite or amalgam restorations. Matrix bands (such as those in the UNIMATRIX system) help maintain the shape of interproximal spaces during filling, preventing overcontouring and ensuring proper contact between teeth.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 900580358
Catalogue (237)
Page 3 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Praxis | 0002000038 | FDA UDI | Class I | Active |
| Transparent Crowns | 0008000521 | FDA UDI | Class I | Active |
| Praxis | 0002000069 | FDA UDI | Class I | Active |
| Sandpaper Discs | 0002020039 | FDA UDI | Class I | Active |
| Transparent Crowns | 0008000523 | FDA UDI | Class I | Active |
| Sandpaper Discs | 0002020070 | FDA UDI | Class I | Active |
| Sandpaper Discs | 0002020043 | FDA UDI | Class I | Active |
| Sandpaper Discs | 0002020046 | FDA UDI | Class I | Active |
| Transparent Crowns | 0008000554 | FDA UDI | Class I | Active |
| Praxis | 0002000052 | FDA UDI | Class I | Active |
| Sandpaper Discs | 0002020072 | FDA UDI | Class I | Active |
| Sandpaper Discs | 0002020040 | FDA UDI | Class I | Active |
| Prophylactic Strip | 0009010101 | FDA UDI | Class I | Active |
| Optimize | 0000000012 | FDA UDI | Class I | Active |
| Transparent Crowns | 0008000576 | FDA UDI | Class I | Active |
| Transparent Crowns | 0008000590 | FDA UDI | Class I | Active |
| Diamond Strip | 0006010013 | FDA UDI | Class I | Active |
| Transparent Crowns | 0008000588 | FDA UDI | Class I | Active |
| Transparent Crowns | 0008000516 | FDA UDI | Class I | Active |
| Microcut | 0005000021 | FDA UDI | Class I | Active |
| Praxis | 0002000055 | FDA UDI | Class I | Active |
| Transparent Crowns | 0008000514 | FDA UDI | Class I | Active |
| Cervical Matrix | 0005040016 | FDA UDI | Class I | Active |
| Praxis | 0002000059 | FDA UDI | Class I | Active |
| Transparent Crowns | 0008000517 | FDA UDI | Class I | Active |
| Unimatrix R | 0003020102 | FDA UDI | Class I | Active |
| Praxis | 0002000071 | FDA UDI | Class I | Active |
| Transparent Crowns | 0008000549 | FDA UDI | Class I | Active |
| Transparent Crowns | 0008000580 | FDA UDI | Class I | Active |
| Transparent Crowns | 0008000540 | FDA UDI | Class I | Active |
| Praxis | 0002000040 | FDA UDI | Class I | Active |
| Polyester Matrix Strip | 0003050001 | FDA UDI | Class I | Active |
| Abrasive Strips | 0006000003 | FDA UDI | Class I | Active |
| Transparent Crowns | 0008000525 | FDA UDI | Class I | Active |
| Transparent Crowns | 0008000553 | FDA UDI | Class I | Active |
| Diamond Strip | 0006010015 | FDA UDI | Class I | Active |
| Transparent Crowns | 0008000518 | FDA UDI | Class I | Active |
| Transparent Crowns | 0008000552 | FDA UDI | Class I | Active |
| Praxis | 0002000048 | FDA UDI | Class I | Active |
| Transparent Crowns | 0008000509 | FDA UDI | Class I | Active |
| Tofflemire Matrix | 0003040003 | FDA UDI | Class I | Active |
| Transparent Crowns | 0008000566 | FDA UDI | Class I | Active |
| Serrated Diamond Strip | 0006010005 | FDA UDI | Class I | Active |
| Transparent Crowns | 0008000508 | FDA UDI | Class I | Active |
| Transparent Crowns | 0008000005 | FDA UDI | Class I | Active |
| Transparent Crowns | 0008000558 | FDA UDI | Class I | Active |
| Mandrel Praxis | 0010000009 | FDA UDI | Class I | Active |
| Transparent Crowns | 0008000522 | FDA UDI | Class I | Active |
| Finishing And Polishing Strips | 0006020007 | FDA UDI | Class I | Active |
| Transparent Crowns | 0008000565 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Tdv Dental Ltda POMERODE Santa Catarina · BR FEI 3000246713