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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 9 of 256| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| artegral HD | posteriors; shade B3; size L; upper jaw | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life upper anteriors, IL, D4 | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life upper anteriors, CS, B4 | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life lower posteriors, S, D4 | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life upper posteriors, M, D4 | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life lower posteriors, L, B3 | FDA UDI | Class II | Active |
| artVeneer | anteriors; shade A1; mould CS | FDA UDI | Class II | Active |
| artVeneer | anteriors; shade C2; mould IS | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad Mn6 PLSEbim6DFm B2ECO dark pink | FDA UDI | Class II | Active |
| artegral HD | posteriors; shade BL4; size XS; lower jaw | FDA UDI | Class II | Active |
| Polystar Selection EDITION | anteriors; shade D2 light; mould UM4 | FDA UDI | Class II | Active |
| artVeneer | posteriors; shade A3; size XS; upper jaw | FDA UDI | Class II | Active |
| artVeneer | anteriors; shade B1; mould UCM | FDA UDI | Class II | Active |
| Polystar HK | posteriors; shade B2; size 6; upper jaw | FDA UDI | Class II | Active |
| artegral life | posteriors; shade C2; size S; lower jaw | FDA UDI | Class II | Active |
| Baltic Denture System BD Load | Baltic Denture System BDLoad ↓ Mn6 PLSEum2DFm D2 light pink | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad Mw7 PLSEbim6DFm D2light dark pink | FDA UDI | Class II | Active |
| Baltic Denture System BD Load | Baltic Denture System BDLoad Sw7 PLSEbm6DFs C2 pink | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad Tooth Shade Mn7 PLSEbim6DFm A2light | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad High Impact lower Mm7 PLSEum2DFm C2 dark pin | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad High Impact lower Lm6 PLSEum4DFl BL4 pink | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad High Impact upper Ln6 PLSEbil2DFl BL1 pink | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad High Impact upper Mn7 PLSEbim6DFm C2 pink | FDA UDI | Class II | Active |
| M-PM Disc | M-PM Disc, PMMA-Disc, shade B1 translucent ZIR thickness 25mm, diameter 95mm | FDA UDI | Class II | Unknown |
| DeltaForm | anteriors; shade B2; mould O1 | FDA UDI | Class II | Active |
| artVeneer | anteriors; shade A3 light; mould ITS | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad High Impact upper Lw6 PLSEbil2DFl B2 dark pink | FDA UDI | Class II | Active |
| Polystar HK | posteriors; shade C4; size 3; lower jaw | FDA UDI | Class II | Active |
| DeltaForm | anteriors; shade A2; mould I1 | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad High Impact upper Mm6 PLSEbim6DFm C1 dark pink | FDA UDI | Class II | Active |
| artegral life | anteriors; shade C3; mould CL | FDA UDI | Class II | Active |
| artegral life | anteriors; shade BL3; mould BIS | FDA UDI | Class II | Active |
| integral | anteriors; shade C1; mould UIL | FDA UDI | Class II | Active |
| Polystar HK | anteriors; shade C3; mould 97 | FDA UDI | Class II | Active |
| artVeneer | posteriors; shade D3 light; size M; upper jaw | FDA UDI | Class II | Active |
| artVeneer | anteriors; shade A3.5 light; mould IXL | FDA UDI | Class II | Active |
| Polystar HK | anteriors; shade C3; mould Q 77 | FDA UDI | Class II | Active |
| artegral life | anteriors; shade D4; mould BIM | FDA UDI | Class II | Active |
| artegral life | posteriors; shade C4; size S; upper jaw | FDA UDI | Class II | Active |
| Polystar Selection EDITION | anteriors; shade D3; mould CL2 | FDA UDI | Class II | Active |
| artegral | anteriors; shade A2 light; mould BS | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad Mw7 PLSEbim6DFm A3 ECO dark pink | FDA UDI | Class II | Active |
| artegral HD | posteriors; shade A4; size XS; upper jaw | FDA UDI | Class II | Active |
| artegral | anteriors; shade BL3; mould IS | FDA UDI | Class II | Active |
| artegral life | anteriors; shade A2; mould CL | FDA UDI | Class II | Active |
| Polystar Selection EDITION HD | posteriors; shade BL3; size S; lower jaw | FDA UDI | Class II | Active |
| Polystar Selection EDITION | posteriors; shade A4; size M; upper jaw | FDA UDI | Class II | Active |
| Polystar Selection EDITION | anteriors; shade C3; mould BIL1 | FDA UDI | Class II | Active |
| Polystar Selection EDITION | anteriors; shade B1; mould BIL1 | FDA UDI | Class II | Active |
| DeltaForm HD | DeltaForm HD upper posteriors, L, C1 -MADE IN GERMANY- | FDA UDI | Class II | Active |
Related Companies
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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