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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 5 of 256| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| artegral | anteriors; shade B3; mould ITS | FDA UDI | Class II | Active |
| Baltic Denture System BD Load | Baltic Denture System BDLoad Ln6 PLSEbil2DFl B3 ECO pink | FDA UDI | Class II | Active |
| CORiTEC PMMA Disc | CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade B3, with notch | FDA UDI | Class II | Active |
| artegral | anteriors; shade A3; mould UBM | FDA UDI | Class II | Active |
| artegral HD | posteriors; shade A2; size M; upper jaw | FDA UDI | Class II | Active |
| artegral | anteriors; shade D3; mould ITL | FDA UDI | Class II | Active |
| artegral | anteriors; shade B3; mould UBXL | FDA UDI | Class II | Active |
| artegral | anteriors; shade A4; mould UIS | FDA UDI | Class II | Active |
| artegral | anteriors; shade A3; mould BM | FDA UDI | Class II | Active |
| PEEK BioSolution | PEEK BioSolution A2/B2 diameter 95mm, thickness 30mm | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life lower posteriors, M, A2 | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life upper anteriors, BM, C1 | FDA UDI | Class II | Active |
| integral | anteriors; shade D2; mould UBS | FDA UDI | Class II | Active |
| Polystar HK | anteriors; shade D4; mould D 82 | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad High Impact lower Ln6 PLSEum4DFl A4ECO dark pink | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad High Impact lower Mn7 PLSEum2DFm A2ECO pink | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad ↓ Sw6 PLSEum6DFs C1ECO dark pink | FDA UDI | Class II | Active |
| DeltaForm | anteriors; shade C4; mould R3 | FDA UDI | Class II | Active |
| artVeneer | anteriors; shade A2 light; mould BOL | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad High Impact lower Mn6 PLSEum2DFm D2light pin | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad Sw6 PLSEbm6DFs C3ECO dark pink | FDA UDI | Class II | Active |
| artegral life | anteriors; shade BL1; mould UBIL | FDA UDI | Class II | Active |
| integral | anteriors; shade A3.5; mould UBM | FDA UDI | Class II | Active |
| Polystar HK | anteriors; shade C2; mould R 69 | FDA UDI | Class II | Active |
| integral | anteriors; shade A3; mould UBXS | FDA UDI | Class II | Active |
| Polystar HK | posteriors; shade C2; size 40; lower jaw | FDA UDI | Class II | Active |
| artegral life | anteriors; shade A3; mould BOS | FDA UDI | Class II | Active |
| Polystar HK | posteriors; shade A2; size 30; upper jaw | FDA UDI | Class II | Active |
| artegral life | anteriors; shade B4; mould ITL | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad High Impact lower Lw6 PLSEum4DFl C1 dark pink | FDA UDI | Class II | Active |
| M-PM Disc | M-PM Disc, PMMA-Disc, shade D4 translucent thickness 25mm, diameter 98,5mm | FDA UDI | Class II | Active |
| M-PM Disc | M-PM Disc, PMMA-Disc, shade B4 translucent ZIR thickness 20mm, diameter 95mm | FDA UDI | Class II | Active |
| artBloc Temp | 10 artBloc Temp-PMMA-bloc, shade D2, 15,5x19,0x39,0mm | FDA UDI | Class II | Active |
| Baltic Denture System BD Load | Baltic Denture System BD Load BDLoad ↓ Mn6 PLSEum2DFm BL1ECO pink | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad High Impact lower Mw6 PLSEum2DFm A1pink | FDA UDI | Class II | Active |
| Baltic Denture System BD Load | Baltic Denture System BDLoad Sw6 PLSEbm6DFs C4 pink | FDA UDI | Class II | Active |
| artVeneer | anteriors; shade A4; mould UBL | FDA UDI | Class II | Active |
| Polystar Selection EDITION | anteriors; shade D3; mould CM2 | FDA UDI | Class II | Active |
| Polystar HK | anteriors; shade B2; mould 96 | FDA UDI | Class II | Active |
| Polystar HK | anteriors; shade A3.5; mould Q 63 | FDA UDI | Class II | Active |
| Polystar Selection EDITION | anteriors; shade D2; mould UM10 | FDA UDI | Class II | Active |
| Polystar Selection EDITION | anteriors; shade D3; mould BIM6 | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad Mm7 PLSEbim6DFm BL4ECO dark pink | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad ↓ Sw6 PLSEum6DFs A3light dark pink | FDA UDI | Class II | Active |
| DeltaForm HD | DeltaForm HD lower posteriors, XS, C1 -MADE IN GERMANY- | FDA UDI | Class II | Active |
| Polystar Selection EDITION | posteriors; shade C3; size XL; lower jaw | FDA UDI | Class II | Active |
| Baltic Denture System BD Load | Baltic Denture System BDLoad Mw7 PLSEbim6DFm A4 pink | FDA UDI | Class II | Active |
| Baltic Denture System BD Load | Baltic Denture System BDLoad Mm7 PLSEbim6DFm C3 pink | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad High Impact upper Mw7 PLSEbim6DFm D4ECO dark pink | FDA UDI | Class II | Active |
| artegral life HD | artegral life HD SZ D4 SO | 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