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Harvard Dental International GmbH

Germany·DE-MF-000010845

Last updated October 7, 2026

What Harvard Dental International GmbH makes

Harvard Dental International GmbH manufactures dental materials including composite resins for fillings, zinc phosphate and zinc polycarboxylate cements for restorative procedures, and glass ionomer cements for tooth repairs. Their portfolio also includes silicone impression materials for dental molds, temporary crowns and bridges, and bonding agents for dentine preparation. The company produces hygroscopic cements for long-term dental restorations and MTA-based materials for endodontic treatments.

All listed devices fall under FDA Class II regulation and are recorded in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable U.S. regulatory standards for dental materials.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
Germany
Address
2, Robert-Bosch-Strasse, Elmshorn, Germany
LinkedIn
—
Facebook
—
Phone
+493099289780
PRRC Contact
Dr. Marian Casny
EUDAMED SRN
DE-MF-000010845
FDA FEI Number
—
DUNS Number
341553293

Catalogue (188)

Page 4 of 4
DeviceModel / ReferenceRegistriesClassStatus
Harvard PremiumSil Putty Fast 7083752
FDA UDI
Class IIActive
Harvard Bite 7083700
FDA UDI
Class IIActive
Harvard Temp Cem EasyDose 7081103
FDA UDI
Class IIActive
Harvard Cement quick setting, Single powder, Shade 1 7001501
FDA UDI
Class IIActive
Harvard Bond TE Mono 7083607
FDA UDI
Class IIActive
Harvard Cement quick setting, Single liquid 7001600
FDA UDI
Class IIActive
Harvard Cement quick setting, Single powder, Shade 3 7001503
FDA UDI
Class IIActive
VITA ADIVA F-CEM White Opaque FAFCEMWO5
EUDAMEDFDA UDI
Class IIActive
Harvard Cement normal setting, Clinic powder, Shade 3 7002203
FDA UDI
Class IIActive
Harvard Temp C&B Pro A2 7081642
FDA UDI
Class IIActive
Harvard Temp C&B A1 7081651
FDA UDI
Class IIActive
Harvard PremiumSil Heavy Fast 7083732
FDA UDI
Class IIActive
Harvard Cement normal setting, Clinic powder, Shade 8 7002208
FDA UDI
Class IIActive
Harvard Cement normal setting, Single liquid 7002600
FDA UDI
Class IIActive
Harvard PremiumSil Putty Soft Fast 7083742
FDA UDI
Class IIActive
Harvard Ionoresin Fill OptiCaps A2 17727
FDA UDI
Class IIActive
Harvard Polycarboxylat Cement, Clinic powder, Shade 3 7031203
FDA UDI
Class IIActive
Harvard Cement quick setting, Single powder, Shade 4 7001504
FDA UDI
Class IIActive
Harvard Restore A1 7083201
FDA UDI
Class IIActive
Harvard Ionoglas Cem Extra OptiCaps, Shade Universal 7042250
EUDAMEDFDA UDI
Class IIActive
Harvard Ionoglas Fill A3 7051116
FDA UDI
Class IIActive
Harvard Ionoresin Fill OptiCaps A3 7071251
FDA UDI
Class IIActive
Harvard Cement quick setting, Clinic powder, Shade 1 7001201
FDA UDI
Class IIActive
Harvard RestoreFlow A3, 5 7083214
FDA UDI
Class IIActive
Harvard RestoreFlow A1 7083211
FDA UDI
Class IIActive
Harvard MTA Universal OptiCaps 7081502
FDA UDI
Class IIActive
Harvard TraySive 7083753
FDA UDI
Class IIActive
Harvard PremiumFill OptiTips A2 7083624
FDA UDI
Class IIActive
Harvard Bond SE Dual 7083602
FDA UDI
Class IIActive
Harvard PremiumFill OptiTips A1 7083621
FDA UDI
Class IIActive
Harvard PremiumFlow A3 7082213
FDA UDI
Class IIActive
Harvard Restore B1 7083221
FDA UDI
Class IIActive
Harvard Restore C4 7083206
FDA UDI
Class IIActive
Harvard MTA XR OptiCaps 7081505
FDA UDI
Class IIActive
Harvard Polycarboxylat Cement, Single powder, Shade 3 7031503
FDA UDI
Class IIActive
Harvard Temp C&B A2 7081652
FDA UDI
Class IIActive
Harvard Cement OptiCaps, Shade Universal 17943
FDA UDI
Class IIActive
Harvard ZirconCore A3 17724
FDA UDI
Class IIActive

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