Pure Global

Bien-Air Dental Micromotors and Control Systems - HSA Registration DE0011364

Access comprehensive regulatory information for Bien-Air Dental Micromotors and Control Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0011364 and owned by Bien-Air Dental SA. The device was registered on October 17, 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 Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0011364
Bien-Air Dental Micromotors and Control Systems
HSA Registration Number: DE0011364
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

Intended for use in dentistry for implantology, dental surgery and endodontic work

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0011364
Registration Date
October 17, 2012
Change Notification Approval Date
November 06, 2024
Retention Due Date
October 16, 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)
LED LIGHT UPGRADE SET LED LIGHT UPGRADE SET PM 1:1 EXT SPRAY MOT AQUILON830 IR NC MOT MC3 IR MOT MC2 IR MOT MC2 GT AV MOT BASCH MOT MC3 LK MOT ISOLITE LK HOSE 4VLM11 GREY HOSE 4VLM11 BLACK HOSE 4VLM GREY HOSE 4VLM BLACK HOSE ISOLITE/MC2 GREY BOARD FO822 BOARD FO890 PM 10:1 PROPHY CA 15:1 PROPHY HOSE ISOLITE/MC2 BLACK HOSE ISOLITE/MC2 SWIVEL GREY HOSE ISOLITE/MC2 SWIVEL BLACK HOSE ISOLITE/MC2 COILED BLACK CA 1:5 CABLE BASCH BOARD MPPE021 FO SET MPPE021 FO MOT AQUILON830 SR MOT MX PM 1:1 CA 1:1 L CA 10:1 L CA 1:5 L HOSE 4VX GREY HOSE 4VR400 GREY HOSE B-4VR400 GREY CA 1:1 CA 10:1 HOSE B-4VX GREY PM HP 1:2 BOARD DMX BOARD DMX BASIC CA 30:1 EXT SPRAY WELDED CONSOLE OPTIMA MX INT CA 20:1 L CA 1122 MOT MX LED CABLE MX LED CONSOLE CHIROPRO L FOOTCTRL CHIROPRO L CA 20:1 BOARD DMX2 PRO MOT MX2 MOT MC3 LK MOT ISOLITE LK CA 1:5 L Micro-Series CA 1:1 L Micro-Series CA 20:1 L Micro-Series PM 1:1 Micro-Series BOARD DMX2 PLUS HOSE MX2 400 GREY CONSOLE OPTIMA MX2 INT CONSOLE CHIROPRO MOT MX CHIROPRO CA 1:1L EVO 15 Microseries : PM CA 1:5L EVO15 Micro-Series PM CA 1:5L EVO15 OPTIMA MCX (white) OPTIMA MCX (blue) OPTIMA MCX (orange) OPTIMA MCX (green) OPTIMA MCX (pink) SET CA 1:1+PM 1:1 SET B-4VR400 GREY+SOCKET B MC3 LK + 4VR400 SET AQUILON830 IR NC+UNIFIX 3H SET MOT BASCH+CABLE SET CA 1:1 L+PM 1:1 SET AQUILON830 IR C+UNIFIX 4H SET DMX S SET DMX B SET DMX S 2M+2C SET DMX B 2M+2C SET DMX WITHOUT 24-32 V SET DMX B WITHOUT 24V-32V SET OPTIMA MX INT SET OPTIMA MX INT BASIC SET OPTIMA MX INT+TR SET OPTIMA MX INT BASIC+TR SET CHIROPRO L + CA 20:1 L MC3 LK + 4VLM MC3 IR + 4VLM SET CHIROPRO L US SET CHIROPRO L US + CA 20:1 SET DMX2 PLUS WITHOUT 24-32 V SET DMX2 PLUS SET DMX2 PLUS 2M+2C SET DMX2 PRO WITHOUT 24-32 V SET DMX2 PRO SET DMX2 PRO 2M+2C SET CA 1:1 L+PM 1:1 KIT UPGRADE CHIROPRO L SET OPTIMA MX2 INT PRO SET CHIROPRO SET CHIROPRO + CA 20:1 SET OPTIMA MX2 INT PRO+TR. SET OPTIMA MX2 INT PRO+24V-32V SET OPTIMA MX2 INT PRO 2M SET OPTIMA MX2 INT PLUS SET OPTIMA MX2 INT PLUS+TR. SET OPTIMA MX2 INT PRO SET OPTIMA MX2 INT PRO + B24-32V AP Optima MCX (white) AP Optima MCX (blue) AP Optima MCX (orange) AP Optima MCX (green) AP Optima MCX (pink)
Model Identifier(s)
1501369 1501370 1600052 1600070 1600071 1600073 1600075 1600076 1600077 1600078 1600097 1600098 1600102 1600103 1600120 1600140 1600142 1600289 1600290 1600297 1600298 1600299 1600315 1600325 1600342 1600350 1600351 1600362 1600375 1600383 1600384 1600385 1600386 1600387 1600397 1600398 1600424 1600425 1600428 1600436 1600472 1600473 1600479 1600534 1600598 1600603 1600605 1600606 1600613 1600631 1600632 1600666 1600677 1600680 1600681 1600690 1600691 1600692 1600693 1600696 1600700 1600715 1600724 1600752 1600938-001 1600940-001 1600941-001 1600959-001 1600965-001 1600966-001 1600967-001 1600968-001 1700042 1700043 1700046 1700058 1700074 1700196 1700211 1700230 1700231 1700232 1700233 1700241 1700245 1700258 1700260 1700270 1700271 1700307 1700336 1700337 1700349 1700350 1700376 1700377 1700378 1700379 1700380 1700381 1700384 1700385 1700386 1700387 1700388 1700390 1700391 1700392 1700393 1700394 1700545-001 1700546-001 1700588-001 1700589-001 1700590-001 1700591-001 1700592-001