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Singapore HSA registration DE0010498

Aseptico Calamus Dual

Singapore flagSingapore·CLASS B·Aseptico, Inc.·Registered September 10, 2012
Device classification
Device Class
CLASS B
Medical Speciality Area
Dental
HSA Product Code
Refer to CRPNS
HS Code
90184900
Registration information
Registration Number
DE0010498
Registration Date
September 10, 2012
Retention Due Date
September 09, 2025
Product description
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.
Product Owner
Name
Aseptico, Inc.
Short Name
Aseptico
Address
8333 216th St. S.E., Woodinville, WA., 98072, UNITED STATES
Registrant
Name
DENTSPLY SIRONA SINGAPORE PTE LTD
Address
1 WALLICH STREET, GUOCO TOWER, #18-02, SINGAPORE 078881
Importer
Name
DENTSPLY SIRONA SINGAPORE PTE LTD
Address
1 WALLICH STREET, GUOCO TOWER, #18-02, SINGAPORE 078881
Model information
Model Name(s)
CALAMUS HEATED PLUGGER CALAMUS HEATED PLUGGER CALAMUS HEATED PLUGGER CALAMUS THERMAL RESPONSE TIP CALAMUS CARTRIDGES CALAMUS CARTRIDGES CALAMUS DUAL
Model Identifier(s)
A111000000000 A112000000000 A113000000000 A115000000000 A121000000000 A122000000000 A130000000033
About this record

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B