Rizhao HuGe Biomaterials Company, Ltd.

Address:No.2 North Zhaoyang Road, District of Donggang,Rizhao Shandong,CN

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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) (6) Agent, Tooth Bonding, Resin (KLE) (1)

Premarket Exempt

Clear

Light Cure Dental Adhesive - 06972220484301 Catalog Number : 5ml

Device Class : 2

Duns Number: 544452689

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

Dual Cure Resin Cement - 06972220484363 Catalog Number : TR (Translucent) 8g

Device Class : 2

Duns Number: 544452689

Premarket Exempt : No

Product Code : EMA, EBF

Prescription Use : No

Device Count : 1

Dual Cure Resin Cement - 06972220484370 Catalog Number : A0 (Light+) 8g

Device Class : 2

Duns Number: 544452689

Premarket Exempt : No

Product Code : EMA, EBF

Prescription Use : No

Device Count : 1

Dual Cure Resin Cement - 06972220484387 Catalog Number : A1 (Light) 8g

Device Class : 2

Duns Number: 544452689

Premarket Exempt : No

Product Code : EMA, EBF

Prescription Use : No

Device Count : 1

Dual Cure Resin Cement - 06972220484394 Catalog Number : A3 (Dark) 8g

Device Class : 2

Duns Number: 544452689

Premarket Exempt : No

Product Code : EMA, EBF

Prescription Use : No

Device Count : 1

Dual Cure Resin Cement - 06972220484400 Catalog Number : White (White Opaque) 8g

Device Class : 2

Duns Number: 544452689

Premarket Exempt : No

Product Code : EMA, EBF

Prescription Use : No

Device Count : 1

Dual Cure Resin Cement - 06972220484417 Catalog Number : Opaque (Universal Opaque) 8g

Device Class : 2

Duns Number: 544452689

Premarket Exempt : No

Product Code : EMA, EBF

Prescription Use : No

Device Count : 1

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