PRISMA GLOSS - Indonesia BPOM Medical Device Registration
PRISMA GLOSS is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20602612348. The device is manufactured by DENTSPLY CAULK from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. DENTSPLY SIRONA INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
DENTSPLY CAULKCountry of Origin
United States
Authorized Representative
PT. 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
Mar 10, 2023
Expiry Date
Apr 01, 2026
Product Type
Prosthetic Dental Equipment
Tooth shade resin material.
Non Electromedic Non Sterile
DENTSPLY Esthet - X Flow Liquid Micro Hybrid
DENTSPLY The Palodent System
FLUOROCORE2+
PALODENT V3 Sectional Matrix System
DYCAL Radiopaque Calcium Hydroxide Composition Dentin
AQUASIL ULTRA+ Smart Wetting Impression Material
AQUASIL ULTRA+ Smart Wetting Impression Material
IRM Standard Package - Ivory
DENTSPLY REGISIL Rigid Vinyl Polysiloxane Bite Reg
SUREFIL High Density Posterior Restorative
PRIMEPRINT Guide
DETAX GMBH
DENTSPLY SIRONA Dental Treatment Unit
SIRONA DENTAL SYSTEMS GMBH
ANTAEOS Root Filler 'L"
MAILLEFER INSTRUMENTS HOLDING Sร RL
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 Radix Anker Standard
MAILLEFER INSTRUMENTS HOLDING SARL.
DENTSPLY Maillefer Transmetal
MAILLEFER INSTRUMENT HOLDING SARL.

