Cleared Traditional

K980585 - MILLENNIUM

K980585 is an FDA 510(k) clearance for MILLENNIUM, manufactured by Biolase Technology, Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K980585 · Biolase Technology, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
233d
Days
Class 1
Risk

K980585 is an FDA 510(k) clearance for the MILLENNIUM. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Biolase Technology, Inc. (Clemente, US). The FDA issued a Cleared decision on October 8, 1998 after a review of 233 days - an extended review cycle.

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 Biolase Technology, Inc. devices

FDA 510(k) Submission Details - K980585

510(k) Number K980585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1998
Decision Date October 08, 1998
Days to Decision 233 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
106d slower than avg
Panel avg: 127d · This submission: 233d
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 132
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K980585.
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