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Merz 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
—
LinkedIn
—
Facebook
—
Phone
+494381403411
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
324914910

Catalogue (12765)

Page 3 of 256
DeviceModel / ReferenceRegistriesClassStatus
artegral posteriors; shade D4; size S; lower jaw
FDA UDI
Class IIActive
artVeneer anteriors; shade A2; mould UBXL
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad High Impact upper Mw6 PLSEbim6DFm BL1 pink
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad High Impact upper Sw6 PLSEbm6DFs C2 pink
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad ↓ Sm7 PLSEum6DFs D2 ECO dark pink
FDA UDI
Class IIActive
Polystar Selection EDITION posteriors; shade B4; size S; lower jaw
FDA UDI
Class IIActive
artVeneer anteriors; shade BL4; mould ITM
FDA UDI
Class IIActive
artegral life anteriors; shade A1; mould IM
FDA UDI
Class IIActive
Polystar HK anteriors; shade A1; mould Q 83
FDA UDI
Class IIActive
Polystar Selection EDITION anteriors; shade D4; mould US2
FDA UDI
Class IIActive
integral anteriors; shade BL2; mould UBM
FDA UDI
Class IIActive
DeltaForm posteriors; shade BL4; size XL; lower jaw
FDA UDI
Class IIActive
DeltaForm HD DeltaForm HighDefinition posterior; shade B1; size S; lower jaw
FDA UDI
Class IIActive
artVeneer anteriors; shade BL1; mould BL
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad High Impact upper Mn7 PLSEbim6DFm D2light dark pink
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad ↓ Mn6 PLSEum2DFm B3ECO dark pink
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad High Impact lower Sm7 PLSEum6DFs D2light pin
FDA UDI
Class IIActive
Baltic Denture System BD Load Baltic Denture System BDLoad Lw6 PLSEbil2DFl C1 ECO pink
FDA UDI
Class IIActive
Baltic Denture System BD Load Baltic Denture System BDLoad ↓ Mn6 PLSEum2DFm B1 ECO pink
FDA UDI
Class IIActive
artegral anteriors; shade B4; mould UBIL
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad High Impact lower Mm7 PLSEum2DFm C3ECO pink
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad ↓ Sm7 PLSEum6DFs D2light dark pink
FDA UDI
Class IIActive
Baltic Denture System BD Load Baltic Denture System BDLoad ↓ Sm7 PLSEum6DFs BL1 pink
FDA UDI
Class IIActive
artegral life anteriors; shade B3; mould BIS
FDA UDI
Class IIActive
DeltaForm anteriors; shade A1; mould I1
FDA UDI
Class IIActive
Polystar HK posteriors; shade A2; size 60; upper jaw
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad High Impact lower Mn7 PLSEum2DFm D2ECO dark pink
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad Lm6 PLSEbil2DFl C2 dark pink
FDA UDI
Class IIActive
Polystar Selection EDITION anteriors for Ceramill FDS of Amann Girrbach anteriors; shade BL1; mould BIL2
FDA UDI
Class IIUnknown
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad High Impact upper Mn7 PLSEbim6DFm BL4 pink
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad ↓ Mn6 PLSEum2DFm C2ECO dark pink
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad ↓ Lw6 PLSEum4DFl C3 dark pink
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad High Impact lower Mn7 PLSEum2DFm D3ECO pink
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad High Impact lower Ln6 PLSEum4DFl B3 pink
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad Sw7 PLSEbm6DFs BL4 dark pink
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad ↓ Sw6 PLSEum6DFs C1 dark pink
FDA UDI
Class IIActive
M-PM Disc M-PM Disc, PMMA-Disc, shade D4 translucent thickness 20mm, diameter 98,5mm
FDA UDI
Class IIActive
integral anteriors; shade B1; mould BM
FDA UDI
Class IIActive
artVeneer anteriors; shade C4; mould ITL
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad High Impact upper Mn7 PLSEbim6DFm BL4ECO dark pink
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad High Impact upper Mm6 PLSEbim6DFm C2ECO pink
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad Sm6 PLSEbm6DFs C4 dark pink
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad High Impact lower Sm6 PLSEum6DFs A4 pink
FDA UDI
Class IIActive
integral anteriors; shade A4; mould UBS
FDA UDI
Class IIActive
artVeneer life artVeneer life upper anteriors, BL, B4
FDA UDI
Class IIActive
Polystar HK anteriors; shade A3; mould D 68
FDA UDI
Class IIActive
Polystar Selection EDITION HD posteriors; shade BL1; size S; upper jaw
FDA UDI
Class IIActive
artVeneer anteriors; shade A2; mould BM
FDA UDI
Class IIActive
Baltic Denture System BD Load Baltic Denture System BDLoad Sm7 PLSEbm6DFs BL3 pink
FDA UDI
Class IIActive
Polystar HK anteriors; shade A2; mould R 55
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

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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