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Sign in to claim this brandDr. Walser Dental GmbH
US
Last updated May 23, 2026
What Dr. Walser Dental GmbH makes
Dr. Walser Dental GmbH manufactures reusable dental instruments and materials, including matrix bands for tooth preparation, instrument trays for organizing dental tools, and rubber dam clamp forceps. Their product line also includes dressing/utility forceps designed for precision handling in dental procedures. The majority of their offerings are specialized matrices used in restorative dentistry, such as those for composite or amalgam fillings.
All devices produced by the company fall under Class I regulatory classification in the FDA’s Unique Device Identifier (UDI) system. These products are listed in the FDA’s UDI database, adhering to mandatory identification and tracking requirements for medical devices. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Dr. Walser Dental GmbH manufacture?
Dr. Walser Dental GmbH specializes in reusable dental instruments and materials. Their primary products include dental matrix bands—used for shaping tooth cavities during fillings—reusable instrument trays for organizing dental tools, rubber dam clamp forceps for isolating teeth during procedures, and dressing/utility forceps for precise handling of dental materials. Most of their devices are specialized matrices designed for restorative dentistry, such as those used with composite or amalgam fillings.
Where is Dr. Walser Dental GmbH based, and how does that affect their regulatory standing?
Dr. Walser Dental GmbH is based in the United States. Since their devices are listed in the FDA’s Unique Device Identifier (UDI) database, they comply with U.S. regulatory requirements for medical device identification and tracking. The company’s location means their products are subject to FDA oversight, including mandatory UDI registration for Class I devices, which is the regulatory classification for their offerings.
Which regulatory registries or databases list Dr. Walser Dental GmbH’s devices?
Dr. Walser Dental GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is mandatory for medical devices in the U.S. and ensures traceability and compliance with regulatory tracking requirements. The inclusion of their products in this system reflects adherence to FDA guidelines for Class I devices, which are generally considered low-risk but still subject to identification and reporting standards.
How are Dr. Walser Dental GmbH’s devices classified under U.S. regulations?
All devices manufactured by Dr. Walser Dental GmbH fall under Class I regulatory classification in the FDA’s system. This classification applies to low-risk medical devices, such as reusable dental instruments like matrix bands, forceps, and trays. Class I devices typically require general controls (e.g., proper labeling, manufacturing practices) but do not undergo premarket approval or postmarket surveillance beyond standard compliance checks. Their inclusion in the FDA’s UDI database further confirms this classification.
Why are Dr. Walser Dental GmbH’s products primarily reusable, and what does that imply for their regulatory approach?
Dr. Walser Dental GmbH’s focus on reusable devices—such as matrix bands, forceps, and instrument trays—aligns with dental practices prioritizing hygiene, cost-efficiency, and sustainability. Reusability implies these products undergo rigorous cleaning and sterilization protocols to meet infection control standards. Regulatory-wise, this classification (Class I) still applies, but the manufacturer must ensure compliance with FDA guidelines on reprocessing and maintenance documentation to confirm the devices remain safe and functional for repeated use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 344549605
Catalogue (47)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Walser® matrices | 024 | FDA UDI | Class I | Active |
| Walser® matrices | 014 | FDA UDI | Class I | Active |
| Walser® matrices | 021 | FDA UDI | Class I | Active |
| Walser® matrix forceps | 036 | FDA UDI | Class I | Active |
| Walser® matrices | 002 | FDA UDI | Class I | Active |
| Walser® matrices | 008 | FDA UDI | Class I | Active |
| Walser® matrices | 015 | FDA UDI | Class I | Active |
| Walser® matrices | 006 | FDA UDI | Class I | Active |
| Walser® matrices | 013 | FDA UDI | Class I | Active |
| Walser® matrices | 008a | FDA UDI | Class I | Active |
| Walser® matrices | 012 | FDA UDI | Class I | Active |
| Walser® matrices | 010 | FDA UDI | Class I | Active |
| Walser® Plastoferm-Löffel L | 0 | FDA UDI | Class I | Unknown |
| Walser® matrices | 007 | FDA UDI | Class I | Active |
| Walser® MPI Löffel | 0 | FDA UDI | Class I | Unknown |
| Walser® matrices | 026 | FDA UDI | Class I | Active |
| Walser® matrices | 006c | FDA UDI | Class I | Active |
| Walser® matrices | 010c | FDA UDI | Class I | Active |
| Walser® matrices | 009 | FDA UDI | Class I | Active |
| Walser® matrices | 031 | FDA UDI | Class I | Active |
| Walser® matrices | 010c/6c | FDA UDI | Class I | Active |
| Walser® matrices | 022 | FDA UDI | Class I | Active |
| Walser® matrices | 028 | FDA UDI | Class I | Active |
| Walser® matrices | 026Spez | FDA UDI | Class I | Active |
| Walser® matrices | 026Kind | FDA UDI | Class I | Active |
| Walser® matrices | 001 | FDA UDI | Class I | Active |
| Walser® matrices | 010d | FDA UDI | Class I | Active |
| Walser® matrices | 029 | FDA UDI | Class I | Active |
| Walser® matrices | 018 | FDA UDI | Class I | Active |
| Walser® matrices | 011 | FDA UDI | Class I | Active |
| Walser® matrices | 023 | FDA UDI | Class I | Active |
| Walser® matrices | 032 | FDA UDI | Class I | Active |
| Walser® Inlay- & pin tweezers | 053 | FDA UDI | Class I | Active |
| Walser® matrices | 004 | FDA UDI | Class I | Active |
| Walser® matrices | 005 | FDA UDI | Class I | Active |
| Walser® matrices | 027 | FDA UDI | Class I | Active |
| Walser® matrices | 019 | FDA UDI | Class I | Active |
| Walser® matrices | 030 | FDA UDI | Class I | Active |
| Walser® matrices | 010a | FDA UDI | Class I | Active |
| Walser® matrices | 017 | FDA UDI | Class I | Active |
| Walser® matrices | 016 | FDA UDI | Class I | Active |
| Walser® matrices | 020 | FDA UDI | Class I | Active |
| Walser® Plastoferm-Löffel F | 0 | FDA UDI | Class I | Unknown |
| Walser® matrices | 025 | FDA UDI | Class I | Active |
| Walser® matrices | 010a/8a | FDA UDI | Class I | Active |
| Walser® Injecto-Löffel | 0 | FDA UDI | Class I | Unknown |
| Walser® matrices | 003 | FDA UDI | Class I | Active |
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