SUREFIL ONE ™ - Indonesia BPOM Medical Device Registration
SUREFIL ONE ™ is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20602220223. The device is manufactured by DENTSPLY DETREY GMBH from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is DENTSPLY SIRONA INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
DENTSPLY DETREY GMBHCountry of Origin
Germany
Authorized Representative
DENTSPLY SIRONA INDONESIAAR Address
Tempo Scan Tower 28th Floor, Jl. HR. Rasuna Said Kav.3-4 Kel. Kuningan Timur Kec. Setia Budi, Jakarta Selatan 12950
Registration Date
Sep 23, 2022
Expiry Date
Apr 01, 2026
Product Type
Prosthetic Dental Equipment
Dental cement.
Non Electromedic Non Sterile
NEO SPECTRA ™ ST Flow
NEO SPECTRA™ ST
AH Canal Sealing and Filling Materials
DENTSPLY Applicator Tips
DYRACT XP
DYRACT FLOW
AH More
KALZINOL
DENTSPLY Ceram - X Duo
DENTSPLY SDR SMART DENTIN REPLACEMENT
KENDO K-File CC-CORD
VDW GMBH
ANTAEOS K-Reamer CC-CORD
VDW GMBH
RECIPROC Gutta Percha
DENTSPLY INDÚSTRIA E COMÉRCIO LTDA
BARBED BROACHES Endodontic Instrument
VDW GMBH
AQUASIL Soft Putty
ZHERMACK S.P.A.
VDW. ROTATE Endodontic Instrument
MAILLEFER INSTRUMENTS HOLDING SàRL
RECIPROC BLUE Endodontic Instrument
MAILLEFER INSTRUMENTS HOLDING SàRL
CEREC Primemill
SIRONA DENTAL SYSTEMS GMBH
NEOCOLLOID
ZHERMACK S.P.A.
SCANPOST
SIRONA DENTAL SYSTEMS GMBH

