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) (5) Material, Tooth Shade, Resin (EBF) (3) Agent, Tooth Bonding, Resin (KLE) (2)

Premarket Exempt

Clear

Harvard Bond SE Dual - EHAR177351 Catalog Number :

Device Description : Self-etching dual-curing adhesive (two component system)

Device Class :

Duns Number: 341553293

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 2

Harvard PremiumFill A2 - EHAR177371 Catalog Number :

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

Device Class : 2

Duns Number: 341553293

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Harvard Restore A2 - EHAR177621 Catalog Number :

Device Description : Light cure universal microhybrid composite

Device Class : 2

Duns Number: 341553293

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Harvard RestoreFlow A2 - EHAR177651 Catalog Number :

Device Description : Light cure universal flowable microhybrid composite

Device Class : 2

Duns Number: 341553293

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Harvard Bond SE Mono - EHAR177661 Catalog Number :

Device Description : Light cure self-etching one component adhesive

Device Class : 2

Duns Number: 341553293

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Harvard Cement OptiCaps, Shade Universal - EHAR179431 Catalog Number :

Device Description : Zinc phosphate cement

Device Class :

Duns Number: 341553293

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 2

Harvard Cement quick setting, Clinic powder, Shade 1 - EHAR70012011 Catalog Number :

Device Description : Zinc phosphate cement

Device Class : 2

Duns Number: 341553293

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Harvard Cement quick setting, Clinic powder, Shade 2 - EHAR70012021 Catalog Number :

Device Description : Zinc phosphate cement

Device Class : 2

Duns Number: 341553293

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Harvard Cement quick setting, Clinic powder, Shade 3 - EHAR70012031 Catalog Number :

Device Description : Zinc phosphate cement

Device Class : 2

Duns Number: 341553293

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Harvard Cement quick setting, Clinic powder, Shade 4 - EHAR70012041 Catalog Number :

Device Description : Zinc phosphate cement

Device Class : 2

Duns Number: 341553293

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

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