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Sign in to claim this brandMerz Dental GmbH
US
Last updated May 24, 2026
What Merz Dental GmbH makes
Merz Dental GmbH manufactures resin artificial teeth, preformed complete dentures, and temporary and permanent preformed dental crowns. Their portfolio also includes dental guided surgery reference plates and systems like the Baltic Denture System BDLoad, artegral life, and artVeneer for dental prosthetics and restorative applications.
Their devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company 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 dental devices does Merz Dental GmbH manufacture?
Merz Dental GmbH specializes in dental prosthetics and restorative solutions. Their product portfolio includes resin artificial teeth, preformed complete dentures, temporary and permanent preformed dental crowns, and dental guided surgery reference plates. Examples of their systems include the Baltic Denture System BDLoad, artegral life, and artVeneer, which are designed for dental restorations and prosthetic applications.
Where is Merz Dental GmbH based?
Merz Dental GmbH operates from the United States. While the company name includes 'GmbH,' which is typically associated with German legal structures, their primary business presence and regulatory filings are linked to the U.S. market.
Which regulatory registries list Merz Dental GmbH’s devices?
Merz Dental GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for dental devices authorized under U.S. regulations, including those classified under FDA’s Class I and Class II categories.
How are Merz Dental GmbH’s devices classified under FDA regulations?
Merz Dental GmbH’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- merz-dental.de
- —
- —
- [email protected]
- Phone
- +494381403411
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 324914910
Catalogue (12765)
Page 4 of 256| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad ↓ Lw6 PLSEum4DFl A3,5light dark pink | FDA UDI | Class II | Active |
| Baltic Denture System BD Load | Baltic Denture System BDLoad Mn7 PLSEbim6DFm A2lightpink | FDA UDI | Class II | Active |
| Polystar Selection EDITION | anteriors; shade D4; mould BS2 | FDA UDI | Class II | Active |
| artVeneer | anteriors; shade A2; mould IL | FDA UDI | Class II | Active |
| Polystar Selection EDITION | anteriors; shade B4; mould CM2 | FDA UDI | Class II | Active |
| DeltaForm HD | DeltaForm HD lower posteriors, S, B2 -MADE IN GERMANY- | FDA UDI | Class II | Active |
| artegral | anteriors; shade B2; mould BIM | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad Mn6 PLSEbim6DFm D2 ECO dark pink | FDA UDI | Class II | Active |
| artegral | anteriors; shade A3.5; mould UIM | FDA UDI | Class II | Active |
| artVeneer | anteriors; shade BL3; mould UBIS | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad High Impact upper Mw6 PLSEbim6DFm C1ECO dark pink | FDA UDI | Class II | Active |
| PEEK BioSolution | PEEK BioSolution white diameter 100mm, thickness 16mm | FDA UDI | Class II | Active |
| artVeneer | anteriors; shade C4; mould UBIS | FDA UDI | Class II | Active |
| Polystar HK | anteriors; shade C2; mould 97 | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad High Impact upper Sw7 PLSEbm6DFs C2 pink | FDA UDI | Class II | Active |
| integral | anteriors; shade BL3; mould IM | FDA UDI | Class II | Active |
| integral | anteriors; shade BL1; mould IS | FDA UDI | Class II | Active |
| DeltaForm | anteriors; shade BL3; mould I7 | FDA UDI | Class II | Active |
| Polystar Selection EDITION | posteriors; shade C1; size L; upper jaw | FDA UDI | Class II | Active |
| artVeneer | anteriors; shade A1; mould UIM | FDA UDI | Class II | Active |
| artegral | anteriors; shade A3.5; mould CS | FDA UDI | Class II | Active |
| artegral life | anteriors; shade C2; mould BXL | FDA UDI | Class II | Active |
| artVeneer | posteriors; shade D2; size L; lower jaw | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life upper anteriors, CL, C4 | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad High Impact lower Mw6 PLSEum2DFm C4ECO pink | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life upper anteriors, IL, C3 | FDA UDI | Class II | Active |
| artegral | anteriors; shade D3 light; mould UCL | FDA UDI | Class II | Active |
| artegral | anteriors; shade BL1; mould BOM | FDA UDI | Class II | Active |
| Baltic Denture System BD Load | Baltic Denture System BDLoad ↓ Sm6 PLSEum6DFs B3 pink | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad ↓ Mm6 PLSEum2DFm C2 dark pink | FDA UDI | Class II | Active |
| Baltic Denture System BD Load | Baltic Denture System BDLoad Mm7 PLSEbim6DFm A3,5light pink | FDA UDI | Class II | Active |
| integral | anteriors; shade A4; mould UIM | FDA UDI | Class II | Active |
| Polystar Selection EDITION | posteriors; shade C2; size M; upper jaw | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad High Impact upper Mw7 PLSEbim6DFm B3 pink | FDA UDI | Class II | Active |
| Baltic Denture System BD Load | Baltic Denture System BDLoad ↓ Sw6 PLSEum6DFs D4 pink | FDA UDI | Class II | Active |
| artegral life HD | artegral life HD SZ B3 XSU | FDA UDI | Class II | Active |
| Polystar HK | anteriors; shade C1; mould O 52 | FDA UDI | Class II | Active |
| artVeneer | posteriors; shade C4; size XL; lower jaw | FDA UDI | Class II | Active |
| artegral life HD | artegral life HD SZ B1 SU | FDA UDI | Class II | Active |
| Baltic Denture System BD Load | Baltic Denture System BDLoad ↓ Ln6 PLSEum4DFl C4 ECO pink | FDA UDI | Class II | Active |
| Baltic Denture System BDCreator | Baltic Denture System BDCreator PLUS | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad High Impact upper Ln6 PLSEbil2DFl C1ECO pink | FDA UDI | Class II | Active |
| Baltic Denture System BD Load | Baltic Denture System BD Load BDLoad Sw7 PLSEbm6DFs BL1ECO pink | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life upper posteriors, XS, BL2 | FDA UDI | Class II | Active |
| artegral life HD | artegral life HD SZ B1 XLO | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life lower anteriors, UBXL, A2 | FDA UDI | Class II | Active |
| artegral | anteriors; shade C2; mould UIL | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life upper anteriors, IM, C1 | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life upper anteriors, IS, A35 | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life upper anteriors, ITM, A1 | FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Merz Dental Gmbh LUETJENBURG Schleswig-Holstein · DE FEI 3004086252