Harvard Dental International GmbH

Address:Robert Bosch Strasse 2,Elmshorn Schleswig-Holstein,DE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Cement, Dental (EMA) (6) Material, Tooth Shade, Resin (EBF) (3) Crown And Bridge, Temporary, Resin (EBG) (1)

Premarket Exempt

Clear

Harvard Temp Cem - EHAR177081 Catalog Number :

Device Description : Non-eugenol temporary cement

Device Class : 2

Duns Number: 341553293

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Harvard Implant Semi-permanent - EHAR177201 Catalog Number :

Device Description : Dual cure semi-permanent luting cement

Device Class : 2

Duns Number: 341553293

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Harvard Temp C&B A2 - EHAR177221 Catalog Number :

Device Description : Temporary crown and bridge material 10:1

Device Class : 2

Duns Number: 341553293

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

Harvard ZirconCore A3 - EHAR177241 Catalog Number :

Device Description : Dual cure core build-up and post cementing composite

Device Class : 2

Duns Number: 341553293

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Harvard Ionoresin Fill OptiCaps A2 - EHAR177271 Catalog Number :

Device Description : Resin modified glass ionomer cement for restorations, light cure

Device Class :

Duns Number: 341553293

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 2

Harvard Ionoglas Fill Extra OptiCaps A2 - EHAR177291 Catalog Number :

Device Description : Esthetic glass ionomer cement for restorations

Device Class :

Duns Number: 341553293

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 2

Harvard PremiumFill OptiTips A2 - EHAR177301 Catalog Number :

Device Description : Universal light cure nano-hybrid composite for restorations

Device Class :

Duns Number: 341553293

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 2

Harvard PremiumFlow OptiTips A2 - EHAR177311 Catalog Number :

Device Description : Flowable light cure nano-hybrid composite for restorations

Device Class :

Duns Number: 341553293

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 2

Harvard Ionoglas Cem Extra OptiCaps, Shade Universal - EHAR177321 Catalog Number :

Device Description : Esthetic glass ionomer cement for luting and lining

Device Class :

Duns Number: 341553293

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 2

Harvard Ionoresin Cem OptiCaps, Shade Universal - EHAR177341 Catalog Number :

Device Description : Resin modified glass ionomer cement for luting and lining, light cure

Device Class :

Duns Number: 341553293

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 2

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