Aseptico Calamus Dual - HSA Registration DE0010498
Access comprehensive regulatory information for Aseptico Calamus Dual in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0010498 and owned by Aseptico, Inc.. The device was registered on September 10, 2012.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
An integrated obturation device with hand pieces that are used for Downpack (Pack) and Backfill (Flow) of root canals. The Pack hand piece is intended to heat pluggers for warming and softening gutta-percha master cones and searing off gutta-percha cones. This hand piece is also intended to heat accessory thermal response tips that subject a tooth to heat in order to determine pulp vitality. The Flow hand piece is intended for heating and placement of gutta-percha into the root canal. The single-use cartridges are destined for placement of the heated gutta-percha into the cleaned and shaped canal.