bienair.comSET STUDENTS BAUSA 8 - SET of different CA & HP supplied for students.
2024-01-23
BIEN-AIR DENTAL SA
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9614446 | 3002762033 | BIEN-AIR DENTAL SA | 1 | N | 2026-01-01 | LANGGASSE 60 Biel/Bienne Bern CH 2504 |
| 3003268570 | 3003268570 | Bien-Air Dental SA | 1 | N | 2026-01-01 | Rue de l'Ouest 2b Le Noirmont Jura CH 2340 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| J00717000430011 | Set B-4VR400 Grey + Socket B - 1700043-001 | +1 949-477-6050 | ba-usa@bienair.com |
| J007170079601 | SET STUDENTS BAUSA 7 - SET of different CA & HP supplied for students. | +1 949-477-6050 | ba-usa@bienair.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 17815 | 1998235611 | K983183 | GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P | EFB | 1998-12-10 |
| 213399 | 1998235611 | K983183 | GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P | EFB | 1998-12-10 |
| 17815 | 1684657882 | K190509 | Lubrina 2 | EFB | 2020-03-04 |
| 17815 | 1365651475 | K092214 | CHIROPRO L SYSTEM | EBW | 2009-12-15 |
| 17815 | 1873273245 | K070074 | LUBRINA, MODEL HIM-1 | EFB | 2007-05-31 |
| 17815 | 1777135055 | K042759 | OPTIMA MX | EIA | 2004-10-20 |
| 17815 | 1257351065 | ||||
| 213399 | 1365651475 | ||||
| 17815 | 1681232296 | ||||
| 17815 | 1794629702 | ||||
| 17815 | 1982581155 | ||||
| 17815 | 1992860759 |
Product Codes Associated With Registrations#
GUDID#
SET STUDENTS BAUSA 13 - SET of different CA & HP supplied for students.
2024-01-23
SET STUDENTS BAUSA 14 - SET of different CA & HP supplied for students.
2024-01-23
SET STUDENTS BAUSA 7 - SET of different CA & HP supplied for students.
2023-12-13
SET STUDENTS BAUSA 8 - SET of different CA & HP supplied for students.
2023-12-13
SET STUDENTS BAUSA 13 - SET of different CA & HP supplied for students.
2023-12-13
SET STUDENTS BAUSA 14 - SET of different CA & HP supplied for students.
2023-12-13
Set B-4VR400 Grey + Socket B - 1700043-001
2021-06-17
MC3 LK + 4VR400 - Set of micromotor and Accessory connects micro-motors to the console
2021-06-17
Set Aquilon830 IR NC + Unifix 3H - Set of micromotor and Accessory connects micro-motors to the console
2021-06-17
Set Aquilon830 IR C + Unifix 4H - Set of micromotor and Accessory connects micro-motors to the console
2021-06-17
Set Aquilon830 SR + Unifix 3H - Set of micromotor and Accessory connects micro-motors to the console
2021-06-17
Set Aquilon830 SR + Unifix 4H - Set of micromotor and Accessory connects micro-motors to the console
2021-06-17
MC3 LK + 4VLM - Set of micromotor and Accessory connects micro-motors to the console
2021-06-17
Set MC3 IR + 4VLM-11 Grey - Set of micromotor with hose
2021-06-17
Set MC3 LED + 4VR400 Grey - Set of micromotor with hose
2021-06-17
Set MC3 LED + 4VLM-11 - Set of micromotor with hose
2021-06-17
SET STUDENTS BAUSA 4 - SET of different CA & HP supplied for students.
2020-05-11
SET STUDENTS BAUSA 5 - SET of different CA & HP supplied for students.
2020-05-11
SET STUDENTS BAUSA 6 - SET of different CA & HP supplied for students.
2020-05-11
SET STUDENTS BAUSA 7 - SET of different CA & HP supplied for students.
2020-05-11
Sagittal Microsaw - The SAGITTAL MICROSAW is ideal for making straight or slightly curved cuts with high control, especially in confined spaces where tissue preservation is important, like in mandibular surgeries (e.g Facial Feminization Surgery (FFS), for which visibility is particularly low on the posterior part of the mandibula).
2026-04-07
Oscillating Microsaw - The OSCILLATING MICROSAW is adapted for procedures requiring high precision in confined or curved spaces, such as jaw realignment or craniofacial reconstruction. The controlled motion minimizes the risk of damaging nearby tissues.
2026-04-07
smartIPR - Handpiece transfers a mechanical oscillating movement coming from a micromotor to a dedicated tool for orthodontics interproximal reduction.
2026-03-20
MOT MC2 SR - Electric micromotors are designed to transform electricity into mechanic rotation to drive dental hand-pieces and contra-angles.
2021-06-17
Mot Isolite LK - Electric micromotors are designed to transform electricity into mechanic rotation to drive dental hand-pieces and contra-angles.
2021-06-17
Mot Isolite LI - Electric micromotors are designed to transform electricity into mechanic rotation to drive dental hand-pieces and contra-angles.
2021-06-17
Mot MX - Electric micromotors are designed to transform electricity into mechanic rotation to drive dental hand-pieces and contra-angles.
2021-06-17
Mot MX LED - Electric micromotors are designed to transform electricity into mechanic rotation to drive dental hand-pieces and contra-angles.
2021-06-17
Mot MX2 - Electric micromotors are designed to transform electricity into mechanic rotation to drive dental hand-pieces and contra-angles.
2021-06-17
Mot Isolite (LED) - Electric micromotors are designed to transform electricity into mechanic rotation to drive dental hand-pieces and contra-angles.
2021-06-17
Mot MCX LED - Electric micromotors are designed to transform electricity into mechanic rotation to drive dental hand-pieces and contra-angles.
2021-06-17
MOT MX CHIROPRO - Electric micromotors are designed to transform electricity into mechanic rotation to drive dental hand-pieces and contra-angles.
2021-06-17
Mot MX-i LED - Electric micromotors are designed to transform electricity into mechanic rotation to drive dental hand-pieces and contra-angles.
2021-06-17
Mot MCX - Electric micromotors are designed to transform electricity into mechanic rotation to drive dental hand-pieces and contra-angles.
2021-06-17
MOT MX-i - Electric micromotors are designed to transform electricity into mechanic rotation to drive dental hand-pieces and contra-angles.
2021-06-17
Mot MX-i LED NB - Electric micromotors are designed to transform electricity into mechanic rotation to drive dental hand-pieces and contra-angles.
2021-06-17
MOT MX-i LED 3RD GEN - Electric micromotors are designed to transform electricity into mechanic rotation to drive dental hand-pieces and contra-angles.
2021-06-17
PM OSCILLATING IPR - Handpiece transfers a mechanical oscillating movement coming from a micromotor to a dedicated tool for orthodontics interproximal reduction.
2026-01-23
Console Optima INT - Optima INT is an electronic system developed to be used in general dentistry and endodontics when combined with other dental devices and accessories of devices.
2025-11-10