Glass Ionomer Restorative Material - India CDSCO Medical Device Registration

Glass Ionomer Restorative Material is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000028_94aa2870f47f2e9c146b3b07c2b0cad7_ad9ccdcd459a59a3572c6935fd714a29. This device is marketed under the brand name 3M ESPE Filtek™ P60 Posterior Restorative A3 Shade. The license holder is 3M INDIA LIMITED, and it is classified as Device Class Class B. The approving authority is Pune Division.

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CDSCO Registered

Class Class B

Glass Ionomer Restorative Material

UID: MFG/MD/2021/000028_94aa2870f47f2e9c146b3b07c2b0cad7_ad9ccdcd459a59a3572c6935fd714a29

Brand Name

3M ESPE Filtek™ P60 Posterior Restorative A3 Shade

License Holder

3M INDIA LIMITED

Device Class

Class B

Approving Authority

Pune Division

Product Information

Glass Ionomer based restorative material for dental filling Conventional filling therapy:· As lining for single- or multi-surface composite fillings· Core build ups· Primary tooth fillings · Single-surface fillings in areas not involved in occlusion · Cervical fillings without cosmetic priorities · Semi-permanent single- and multi-surface fillings Minimal intervention (3M ESPE Filtek™ P60 Posterior Restorative A3 Shade) filling therapy (3M ESPE Filtek™ P60 Posterior Restorative A3 Shade): · Primary tooth fillings· Single-surface fillings in areas not involved in occlusion· Semi-permanent single- and multi-surface fillings· Semi-permanent class III and V fillings · Fissure sealings

Class B

Glass Ionomer Restorative Material

3M India Limited

Class B

Brand: 3M ESPE Filtek™ P60 Posterior Restorative A3 Shade

Class B