PRIMEPRINT Guide - Indonesia BPOM Medical Device Registration
PRIMEPRINT Guide is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10602520053. The device is manufactured by DETAX GMBH from Germany, 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
DETAX GMBHCountry of Origin
Germany
Authorized Representative
PT. DENTSPLY SIRONA INDONESIAAR Address
Gedung Tempo Scan Tower, Lantai 28, Jl. H.R. Rasuna Said Kav. 3-4
Registration Date
Feb 12, 2025
Expiry Date
Jul 13, 2028
Product Type
Prosthetic Dental Equipment
Resin impression tray material.
Non Electromedic Non Sterile
DENTSPLY SIRONA Dental Treatment Unit
SIRONA DENTAL SYSTEMS GMBH
ANTAEOS Root Filler 'L"
MAILLEFER INSTRUMENTS HOLDING SàRL
DENTSPLY SIRONA Universal Stain & Overglaze
DS REP B.V.
CERAMCO 3
DS REP B.V.
DENTSPLY MAILLEFER Unimetric Set
MAILLEFER INSTRUMENTS HOLDING S.A.R.L
DENTSPLY Propex Pixi Apex Locator
MAILLEFER INSTRUMENTS HOLDING SARL
CELTRA PRESS
DEGUDENT GMBH.
DENTSPLY Maillefer Transmetal
MAILLEFER INSTRUMENT HOLDING SARL.
DENTSPLY Radix Anker Standard
MAILLEFER INSTRUMENTS HOLDING SARL.
KENDO Hedstroem Files CC-CORD
VDW GMBH.