510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983183Substantially Equivalent

Gyro Long-Life,black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon, Mc2,mc3, Basch, Isolite, Optima, US, Plpe, Ca, P

Bien Air USA, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983183 is the FDA 510(k) clearance record for GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P, a class I device, cleared for Bien Air USA, Inc. on under FDA product code EFB (Handpiece, Air-Powered, Dental). FDA records list 2 510(k) clearances for Bien Air USA, Inc., from to . As of , FDA records show no recalls naming K983183.

Clearance record

Decision date
Received
(90 days to decision)
Product code
EFB Handpiece, Air-Powered, Dental
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
Bien Air USA, Inc. 19600 Fairchild Rd. Suite 250, Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code EFB

Trailing 12 months
3 clearances under product code EFB in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EFB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260