SURESMILE Software - Indonesia BPOM Medical Device Registration
SURESMILE Software is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20604320242. The device is manufactured by ORAMETRIX from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is DENTSPLY SIRONA INDONESIA.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Risk Classification
Product Class
Kelas : 2
Manufacturer
ORAMETRIXCountry of Origin
United States
Authorized Representative
DENTSPLY SIRONA INDONESIAAR Address
Gedung Tempo Scan Tower, Lantai 28, Jl. H.R. Rasuna Said Kav. 3-4
Registration Date
Nov 02, 2023
Expiry Date
Apr 07, 2028
Product Type
Therapeutic Dental Equipment
Orthodontic plastic bracket.
Non Electromedic Non Sterile
KENDO K-File CC-CORD
VDW GMBH
ANTAEOS K-Reamer CC-CORD
VDW GMBH
RECIPROC Gutta Percha
DENTSPLY INDรSTRIA E COMรRCIO LTDA
BARBED BROACHES Endodontic Instrument
VDW GMBH
AQUASIL Soft Putty
ZHERMACK S.P.A.
RECIPROC BLUE Endodontic Instrument
MAILLEFER INSTRUMENTS HOLDING Sร RL
VDW. ROTATE Endodontic Instrument
MAILLEFER INSTRUMENTS HOLDING Sร RL
CEREC Primemill
SIRONA DENTAL SYSTEMS GMBH
NEOCOLLOID
ZHERMACK S.P.A.
SCANPOST
SIRONA DENTAL SYSTEMS GMBH

