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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 8 of 256| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Polystar Selection EDITION | anteriors; shade BL4; mould BIL1 | FDA UDI | Class II | Active |
| artegral life | anteriors; shade C4; mould BL | FDA UDI | Class II | Active |
| artegral | anteriors; shade C4; mould CL | FDA UDI | Class II | Active |
| artVeneer | anteriors; shade C2; mould BIS | FDA UDI | Class II | Active |
| Polystar HK | anteriors; shade A3; mould D 82 | FDA UDI | Class II | Active |
| Baltic Denture System BD Load | Baltic Denture System BDLoad Mw6 PLSEbim6DFm C3 ECO pink | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life upper anteriors, CM, B1 | FDA UDI | Class II | Active |
| artegral | posteriors; shade C4; size S; lower jaw | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life lower anteriors, UBIS, A35 | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life lower anteriors, UBL, A3 | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life lower posteriors, L, D3 | FDA UDI | Class II | Active |
| artegral | anteriors; shade D3 light; mould ITL | FDA UDI | Class II | Active |
| Polystar Selection EDITION HD | posteriors; shade D3; size XL; lower jaw | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life upper anteriors, BOS, BL3 | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life upper posteriors, XL, BL2 | FDA UDI | Class II | Active |
| artegral HD | posteriors; shade A1; size S; lower jaw | FDA UDI | Class II | Active |
| artegral | posteriors; shade C3; size S; upper jaw | FDA UDI | Class II | Active |
| artegral | anteriors; shade A3.5; mould BL | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life lower anteriors, UCS, A2 | FDA UDI | Class II | Active |
| CORiTEC PMMA Disc | CORiTEC PMMA Disc, shade D4 translucent thickness 20mm, diameter 98,5mm, with no | FDA UDI | Class II | Active |
| artegral | anteriors; shade A4; mould ITS | FDA UDI | Class II | Active |
| PEEK BioSolution | PEEK BioSolution A2/B2 diameter 100mm, thickness 24mm | FDA UDI | Class II | Active |
| Polystar Selection EDITION | anteriors; shade A1; mould BIM2 | FDA UDI | Class II | Active |
| artegral | anteriors; shade A3.5; mould UIS | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life upper anteriors, BOM, A2 | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad High Impact upper Ln6 PLSEbil2DFl D3light dark pink | FDA UDI | Class II | Active |
| Baltic Denture System BD Key | Baltic Denture System BDKEY L | FDA UDI | Class II | Active |
| Polystar Selection EDITION | posteriors; shade A3; size XL; lower jaw | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life upper anteriors, ITL, A1 | FDA UDI | Class II | Active |
| CORiTEC PMMA Disc | CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade D3, with notch | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad High Impact upper Lw6 PLSEbil2DFl B2ECO dark pink | FDA UDI | Class II | Active |
| Ceramill TEMP | Ceramill TEMP bleach 71 L20mm US | FDA UDI | Class II | Active |
| artegral | anteriors; shade D2 light; mould IL | FDA UDI | Class II | Active |
| Polystar Selection EDITION | anteriors; shade A2 light; mould CM4 | FDA UDI | Class II | Active |
| artVeneer | anteriors; shade A1; mould UCL | FDA UDI | Class II | Active |
| artegral | anteriors; shade BL1; mould UCL | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life upper anteriors, CS, BL2 | FDA UDI | Class II | Active |
| Baltic Denture System BDLoad | Baltic Denture System BDLoad BDLoad ↓ Mn7 PLSEum2DFm A1 dark pink | FDA UDI | Class II | Active |
| artegral life | anteriors; shade A1; mould ITM | FDA UDI | Class II | Active |
| artVeneer | anteriors; shade A4; mould CL | FDA UDI | Class II | Active |
| Polystar HK | anteriors; shade B1; mould O 52 | FDA UDI | Class II | Active |
| artegral life | anteriors; shade A2; mould UIM | FDA UDI | Class II | Active |
| artVeneer | anteriors; shade C3; mould CS | FDA UDI | Class II | Active |
| artVeneer life | artVeneer life upper anteriors, CM, D3 | FDA UDI | Class II | Active |
| artegral | posteriors; shade A4; size XS; lower jaw | FDA UDI | Class II | Active |
| DeltaForm HD | DeltaForm HD lower posteriors, M, BL1 -MADE IN GERMANY- | FDA UDI | Class II | Active |
| artegral | anteriors; shade C4; mould ITL | FDA UDI | Class II | Active |
| Polystar Selection EDITION | anteriors; shade C1; mould BIL1 | FDA UDI | Class II | Active |
| Polystar Selection EDITION | anteriors; shade A3.5; mould BIL1 | FDA UDI | Class II | Active |
| Polystar Selection EDITION | anteriors; shade D4; mould BIL1 | 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