SURESMILE Aligner - Indonesia BPOM Medical Device Registration
SURESMILE Aligner is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10604320227. The device is manufactured by ORAMETRIX from United States, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. DENTSPLY SIRONA INDONESIA.
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Risk Classification
Product Class
Kelas : 1
Manufacturer
ORAMETRIXCountry of Origin
United States
Authorized Representative
PT. DENTSPLY SIRONA INDONESIAAR Address
Gedung Tempo Scan Tower, Lantai 28, Jl. H.R. Rasuna Said Kav. 3-4
Registration Date
Sep 20, 2023
Expiry Date
Apr 07, 2028
Product Type
Therapeutic Dental Equipment
Preformed tooth positioner.
Non Electromedic Non Sterile
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