GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P

Handpiece, Air-powered, Dental

BIEN AIR USA, INC.

The following data is part of a premarket notification filed by Bien Air Usa, Inc. with the FDA for Gyro Long-life,black Pearl Eco, Ondine &croma, Prestige, Bora, Aquilon, Mc2,mc3, Basch, Isolite, Optima, Us, Plpe, Ca, P.

Pre-market Notification Details

• Device ID: K983183
• 510k Number: K983183
• Device Name: GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P
• Classification: Handpiece, Air-powered, Dental
• Applicant: BIEN AIR USA, INC. 19600 FAIRCHILD RD. SUITE 250 Irvine, CA 92612
• Contact: Arthur Mateen
• Correspondent: Arthur Mateen; BIEN AIR USA, INC. 19600 FAIRCHILD RD. SUITE 250 Irvine, CA 92612
• Product Code: EFB
• CFR Regulation Number: 872.4200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-09-11
• Decision Date: 1998-12-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D9501334700	K983183	000
D950132240	K983183	000
D950132230	K983183	000
D950132220	K983183	000
D950132210	K983183	000