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Bien-Air Dental procedure handpiece, pneumatic - HSA Registration DE0011646

Access comprehensive regulatory information for Bien-Air Dental procedure handpiece, pneumatic in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0011646 and owned by Bien-Air Dental SA. The device was registered on November 22, 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.

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CLASS B
DE0011646
Bien-Air Dental procedure handpiece, pneumatic
HSA Registration Number: DE0011646
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Product Description

A hand-held device used in surgery for drilling, cutting, and inserting procedures involving bones and tough tissues (e.g., cartilage, ligaments). It will typically include a built-in motor and a chuck for attaching drills, bone taps or wires. The device may be cannulated to allow for use of a guidewire and may be of the micro or macro design. It is pneumatically-powered (gas-powered) by either nitrogen (N2) or surgical-grade air via a connecting hose to the handpiece. This is a reusable device.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0011646
Registration Date
November 22, 2012
Change Notification Approval Date
June 15, 2021
Retention Due Date
November 21, 2025
Product Owner
Short Name
Bien-Air Dental
Address
Langgasse 60, CH-2504 Bienne, SWITZERLAND
Registrant
Address
4 MARSILING IND ESTATE ROAD 3, #01-30, SINGAPORE 739250
Importer
Address
2 CLEMENTI LOOP, LOGIS HUB @ CLEMENTI, #01-01, SINGAPORE 129809
Model Information
Model Name(s)
TUR BLACK PEARL ECO 3H TUR BLACK PEARL ECO 4H COUPLING UNIFIX 3H COUPLING UNIFIX 4H COUPLING UNIFIX 4H L WATER ADJ ADAPTER 4H-3H TUR BORA LK COUPLING UNIFIX 4H L TUR PRESTILINA TUR BORALINA TUR PRESTIGE TUR PRESTIGE L TUR BORA TUR BORA L TUR EOLIA B COUPLING EOLIA B 2H-3H COUPLING EOLIA B 4H TUR BORA L BLACKLINE TUR BORA L METALLINE TUR PRESTIGE L BLACKLINE TUR PRESTIGE L METALLINE COUPLING EOLIA B 2H-3H COUPLING EOLIA B 4H COUPLING LK 4HL WATER ADJ COUPLING LK 4HL TUR TORNADO LK TUR TORNADO L TUR TORNADO S LK TUR TORNADO S LED TUR PRESTIGE L+UNIFIX 4H L TUR PRESTIGE+UNIFIX 3H TUR PRESTIGE+UNIFIX 4H TUR BORA+UNIFIX 3H TUR BORA+UNIFIX 4H TUR BORA L+UNIFIX 4H L TUR PRESTILINA+UNIFIX 3H TUR PRESTILINA+UNIFIX 4H TUR BORALINA+UNIFIX 3H TUR BORALINA+UNIFIX 4H TUR EOLIA B+COUPLING 2H-3H TUR EOLIA B+COUPLING 4H SET BORA L BLACKLINE SET PRESTIGE L BLACKLINE TUR BORA L + UNIFIX 4H L TUR PRESTIGE L + UNIFIX 4H L
Model Identifier(s)
1600039 1600040 1600081 1600082 1600086 1600089 1600155 1600363 1600372 1600373 1600379 1600380 1600381 1600382 1600465 1600466 1600467 1600637 1600638 1600640 1600641 1600647 1600648 1600866-001 1600902-001 1600907-001 1600908-001 1600932-001 1600933-001 1700184 1700185 1700186 1700187 1700188 1700189 1700198 1700199 1700200 1700201 1700225 1700226 1700303 1700304 1700305 1700306