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Dental filling materials on composite basis - India CDSCO Medical Device Registration

Dental filling materials on composite basis is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000284_2c6d41f1c0baef284736e8b78ae96633_305ceeee32ad4c320c5f73953b731733. This device is marketed under the brand name MANI. The license holder is Mani Medical India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered
Class Class B
Dental filling materials on composite basis
UID: IMP/MD/2023/000284_2c6d41f1c0baef284736e8b78ae96633_305ceeee32ad4c320c5f73953b731733

Brand Name

MANI

Device Class

Class B

Approving Authority

CDSCO

Product Information

MANI BULK- Fillings with layer thicknesses up to 4 mm in Blackโ€™s class I and II cavities. Base fillings/liners with layer thicknesses up to 4 mm in Blackโ€™s class II cavities. For the following layers in a class II cavity, only use composites which are suited to filling Blackโ€™s class II cavities. Cavity lining โ€“ as a first (MANI) layer in Black's class I and II cavities; MANI FLO - Fissure sealing. Extended fissure sealing on molars and premolars, Fillings in Blackโ€™s class V cavities (MANI). Minimally invasive fillings in Blackโ€™s class I and II cavities in areas not exposed to severe occlusal loads. Minimally invasive fillings in Blackโ€™s class III cavities. Restoring defects in enamel, Blocking out undercuts. Minimal adjustments to the contours and shade of the enamel. MANI FLO-V- Fissure sealing, Extensive fissure sealing on molars and premolars, Fillings in Black's class V (MANI). Minimally invasive fillings in Black's classes I, II and III, Corrections of enamel defects, Blocking out undercuts, small corrections of shape and color of the enamel

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