Cleared Traditional

K983183 - GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P

K983183 is an FDA 510(k) clearance for GYRO LONG-LIFE, manufactured by Bien Air USA, Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K983183 · Bien Air USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
90d
Days
Class 1
Risk

K983183 is an FDA 510(k) clearance for the GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,M.... Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Bien Air USA, Inc. (Irvine, US). The FDA issued a Cleared decision on December 10, 1998 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Bien Air USA, Inc. devices

FDA 510(k) Submission Details - K983183

510(k) Number K983183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1998
Decision Date December 10, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EFB Handpiece, Air-powered, Dental

All 112
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K983183.
ENDO-EZE MOTOR AND HANDPIECE
K992380 · Ultradent Products, Inc. · Oct 1999
SYNEA-HS HIGH SPEED-HANDPIECE
K992011 · A-Dec, Inc. · Sep 1999
TCM 3000 AND TCM ENDO
K981679 · NOUVAG AG · Feb 1999
AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200
K983168 · Ora Innovations, Inc. · Nov 1998
LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE
K982593 · Dentalez Group · Oct 1998
MILLENNIUM
K980585 · Biolase Technology, Inc. · Oct 1998