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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 6 of 256
DeviceModel / ReferenceRegistriesClassStatus
artVeneer life artVeneer life upper anteriors, BXL, BL2
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad ↓ Lm6 PLSEum4DFl D3 ECO dark pink
FDA UDI
Class IIActive
artegral life anteriors; shade B3; mould IM
FDA UDI
Class IIActive
artegral life posteriors; shade A3; size S; lower jaw
FDA UDI
Class IIActive
artegral life anteriors; shade A4; mould UBIS
FDA UDI
Class IIActive
Polystar HK anteriors; shade A3.5; mould 96
FDA UDI
Class IIActive
Polystar HK anteriors; shade A3; mould R 47
FDA UDI
Class IIActive
artVeneer anteriors; shade C1; mould CS
FDA UDI
Class IIActive
artVeneer anteriors; shade C3; mould UBS
FDA UDI
Class IIActive
Polystar HK anteriors; shade C3; mould R 55
FDA UDI
Class IIActive
DeltaForm anteriors; shade A1; mould I8
FDA UDI
Class IIActive
artVeneer posteriors; shade A3 light; size L; upper jaw
FDA UDI
Class IIActive
artegral anteriors; shade BL1; mould UIS
FDA UDI
Class IIActive
Polystar Selection EDITION anteriors; shade BL1; mould UM8
FDA UDI
Class IIActive
artVeneer life artVeneer life upper anteriors, CS, D3
FDA UDI
Class IIActive
Polystar Selection EDITION anteriors for Ceramill FDS of Amann Girrbach anteriors; shade BL2; mould BIM6
FDA UDI
Class IIUnknown
artVeneer anteriors; shade A3.5; mould ITL
FDA UDI
Class IIActive
artegral life anteriors; shade A3.5; mould UBIS
FDA UDI
Class IIActive
Polystar HK anteriors; shade A3.5; mould R 51
FDA UDI
Class IIActive
artegral HD posteriors; shade C4; size M; upper jaw
FDA UDI
Class IIActive
artegral posteriors; shade D2 light; size L; lower jaw
FDA UDI
Class IIActive
artegral posteriors; shade D4; size L; upper jaw
FDA UDI
Class IIActive
artegral anteriors; shade C2; mould ITS
FDA UDI
Class IIActive
Baltic Denture System BD Load Baltic Denture System BDLoad ↓ Ln6 PLSEum4DFl C1 ECO pink
FDA UDI
Class IIActive
Baltic Denture System BD Load Baltic Denture System BDLoad Sm6 PLSEbm6DFs C1 pink
FDA UDI
Class IIActive
M-PRINT Surgical Guide M-PRINT Surgical guide ice-blue, 1000 g
FDA UDI
Class IActive
integral anteriors; shade D4; mould UBM
FDA UDI
Class IIActive
artVeneer anteriors; shade D3; mould UCM
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad High Impact upper Lm6 PLSEbil2DFl D2ECO pink
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad High Impact lower Sm7 PLSEum6DFs A1pink
FDA UDI
Class IIActive
Baltic Denture System BD Load Baltic Denture System BDLoad Mm7 PLSEbim6DFm A4 ECO pink
FDA UDI
Class IIActive
artegral anteriors; shade BL4; mould UIL
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad Mw6 PLSEbim6DFm BL1 dark pink
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad High Impact lower Sw6 PLSEum6DFs A3,5ECO pin
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad High Impact upper Lm6 PLSEbil2DFl D4ECO pink
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad High Impact upper Sw6 PLSEbm6DFs B4 pink
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad Mm7 PLSEbim6DFm BL2 dark pink
FDA UDI
Class IIActive
Baltic Denture System BD Load Baltic Denture System BDLoad Mw7 PLSEbim6DFm B4 ECO pink
FDA UDI
Class IIActive
Baltic Denture System BD Load Baltic Denture System BDLoad ↓ Sm6 PLSEum6DFs D3 ECO pink
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad ↓ Mm6 PLSEum2DFm A4 dark pink
FDA UDI
Class IIActive
artegral life HD artegral life HD SZ BL1 XSU
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad Mw7 PLSEbim6DFm C2ECO dark pink
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad High Impact lower Sm6 PLSEum6DFs BL3 pink
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad High Impact lower Mw7 PLSEum2DFm C3ECO dark pink
FDA UDI
Class IIActive
Baltic Denture System BDLoad Baltic Denture System BDLoad BDLoad High Impact upper Sw7 PLSEbm6DFs C3 pink
FDA UDI
Class IIActive
M-PM Disc M-PM Disc, PMMA-Disc, shade C1 translucent thickness 16mm, diameter 100mm
FDA UDI
Class IIUnknown
Polystar HK anteriors; shade C3; mould R 69
FDA UDI
Class IIActive
artegral life anteriors; shade C2; mould BIM
FDA UDI
Class IIActive
artegral anteriors; shade C2; mould BOL
FDA UDI
Class IIActive
artegral anteriors; shade D2; mould CM
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Merz Dental Gmbh LUETJENBURG Schleswig-Holstein · DE FEI 3004086252