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Aseptico Surgical Implant and Endodontic Dental System - HSA Registration DE0014491

Access comprehensive regulatory information for Aseptico Surgical Implant and Endodontic Dental System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0014491 and owned by Aseptico Inc. The device was registered on December 18, 2013.

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.

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CLASS B
DE0014491
Aseptico Surgical Implant and Endodontic Dental System
HSA Registration Number: DE0014491
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Product Description

The AEU-6000-70V is a drive system for instruments and tools used in dentistry for implant and surgical procedure and endodontic procedure. The system includes an irrigation supply and a wide range of user controls designed to provide precision drilling during osteotomy preparation and implant placement, or endodontic therapy.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
HSA Product Code
HSAMDB00103
HS Code
90184100
Registration Information
Registration Number
DE0014491
Registration Date
December 18, 2013
Retention Due Date
December 17, 2025
Product Owner
Short Name
Aseptico Inc
Address
8333 216th Street S.E., Woodinville, WA98072, UNITED STATES
Registrant
Address
28 KALLANG PLACE, #05-16, SINGAPORE 339158
Importer
Address
28 KALLANG PLACE, #05-16, SINGAPORE 339158
Model Information
Model Name(s)
Surgical Implant & Endodontic Dental System 20:1 Reduction Contra Angle with Adjustable Depth Stop and Gauge Hand Piece 20:1 Reduction Contra Angle Hand Piece
Model Identifier(s)
AEU-6000-70V AHP-85MB-CX AHP-85MB-X