BTK THE SMILE SYSTEM Is+ Implant - Indonesia BPOM Medical Device Registration
BTK THE SMILE SYSTEM Is+ Implant is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20602420005. The device is manufactured by BIOTEC S.R.L. from Italy, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PURE NOBLE SUN.
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
BIOTEC S.R.L.Country of Origin
Italy
Authorized Representative
PURE NOBLE SUNAR Address
Jl. Pecenongan No. 82 C, RT.002/RW.004, Kode Pos 10120, Kel. Kebon Kelapa, Kec. Gambir, Kota Adm. Jakarta Pusat, Provinsi DKI Jakarta
Registration Date
Jan 04, 2024
Expiry Date
Sep 28, 2025
Product Type
Prosthetic Dental Equipment
Endosseous dental implant
Non Electromedic Sterile
YDM Injection Cartridge Syringe Type 2
YDM CORPORATION
BTK THE SMILE SYSTEM Isy Kone Implant
BIOTEC S.R.L.
VERTEX SELF CURING
VERTEX DENTAL B.V
VERTEX BASIQ 20
VERTEX DENTAL B.V
VERTEX THERMOSENS
VERTEX DENTAL B.V
OPTI1STEP POLISHER
KERR CORPORATION
KERR ELEMENTS OBTURATION UNIT
SDS DE MEXICO S. DE R.L DE C.V.
KERR GATES GLIDDEN
MAILLEFER INSTRUMENTS HOLDING SARL
KERR BUCHANAN HAND PLUGGERS
KERR CORPORATION
KERR HEDSTROM FILES
KERR CORPORATION

