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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 2 of 256| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| integral | anteriors; shade D3; mould BL | FDA UDI | Class II | Active |
| DeltaForm | anteriors; shade BL1; mould I5 | FDA UDI | Class II | Active |
| DeltaForm | posteriors; shade BL2; size XS; upper jaw | FDA UDI | Class II | Active |
| DeltaForm | anteriors; shade BL1; mould I2 | FDA UDI | Class II | Active |
| artegral life | anteriors; shade C4; mould BXL | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life upper anteriors, IS, BL3 | FDA UDI | Class II | Active |
| Baltic Denture System BD Load | Baltic Denture System BDLoad Mn6 PLSEbim6DFm C3 ECO pink | FDA UDI | Class II | Active |
| artegral life HD | artegral life HD SZ C2 MU | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life upper anteriors, BXL, D2 | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life lower posteriors, M, C3 | FDA UDI | Class II | Active |
| Polystar Selection EDITION | anteriors; shade A3.5; mould IM6 | FDA UDI | Class II | Active |
| artegral life HD | artegral life HD SZ A2 XLO | FDA UDI | Class II | Active |
| artegral | anteriors; shade B3; mould BOM | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad High Impact lower Sm7 PLSEum6DFs C2ECO dark pink | FDA UDI | Class II | Active |
| artegral | anteriors; shade A2; mould CM | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad High Impact lower Mn7 PLSEum2DFm B2ECO dark pink | FDA UDI | Class II | Active |
| DeltaForm | anteriors; shade C3; mould I1 | FDA UDI | Class II | Active |
| artVeneer | anteriors; shade A3; mould UBIM | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad High Impact lower Mw7 PLSEum2DFm B2 dark pink | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad High Impact upper Mw6 PLSEbim6DFm A4 pink | FDA UDI | Class II | Active |
| artVeneer | posteriors; shade C1; size XS; lower jaw | FDA UDI | Class II | Active |
| integral | anteriors; shade C3; mould UBXS | FDA UDI | Class II | Active |
| DeltaForm | posteriors; shade D3; size XS; upper jaw | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad ↓ Mw6 PLSEum2DFm C2ECO dark pink | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad High Impact lower Mw6 PLSEum2DFm BL2 dark pink | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad High Impact upper Sw7 PLSEbm6DFs A2ECO dark pink | FDA UDI | Class II | Active |
| artegral | posteriors; shade A3; size S; upper jaw | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life upper anteriors, BOM, BL3 | FDA UDI | Class II | Active |
| artegral | anteriors; shade A2; mould BOL | FDA UDI | Class II | Active |
| artegral | posteriors; shade A2 light; size XL; lower jaw | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad Sw6 PLSEbm6DFs BL3 dark pink | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad Mm7 PLSEbim6DFm B2 dark pink | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life lower anteriors, UBXL, B2 | FDA UDI | Class II | Active |
| PEEK BioSolution | PEEK BioSolution A2/B2 diameter 98,5mm, thickness 16mm | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad High Impact upper Sw6 PLSEbm6DFs B4 dark pink | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life lower anteriors, UBL, A1 | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life lower anteriors, UCM, BL2 | FDA UDI | Class II | Active |
| Polystar Selection EDITION anteriors for Ceramill FDS of Amann Girrbach | anteriors; shade C1; mould BIM6 | FDA UDI | Class II | Unknown |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad Mn6 PLSEbim6DFm BL3 dark pink | FDA UDI | Class II | Active |
| Polystar HK | posteriors; shade B2; size 3 S; lower jaw | FDA UDI | Class II | Active |
| artVeneer | anteriors; shade BL2; mould BOS | FDA UDI | Class II | Active |
| artVeneer | anteriors; shade D3; mould IS | FDA UDI | Class II | Active |
| Polystar Selection EDITION | posteriors; shade BL3; size L; lower jaw | FDA UDI | Class II | Active |
| Polystar HK | anteriors; shade C3; mould 94 | FDA UDI | Class II | Active |
| artegral HD | posteriors; shade BL4; size M; upper jaw | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad ↓ Lw6 PLSEum4DFl B3 dark pink | FDA UDI | Class II | Active |
| artegral life | anteriors; shade A2; mould IM | FDA UDI | Class II | Active |
| Polystar Selection EDITION | anteriors; shade C2; mould UM10 | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad High Impact upper Sm7 PLSEbm6DFs A4ECO dark pink | FDA UDI | Class II | Active |
| Baltic Denture System BD Load | Baltic Denture System BD Load BDLoad Mm7 PLSEbim6DFm BL4ECO pink | 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