Cleared Traditional

B&L L-BETA, MODEL WL-B1 (K060347) - FDA 510(k) Clearance

Class I Dental device.

K060347 · B&L Biotech Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
115d
Days
Class 1
Risk

K060347 is an FDA 510(k) clearance for the B&L L-BETA, MODEL WL-B1. Classified as Plugger, Root Canal, Endodontic (product code EKR), Class I - General Controls.

Submitted by B&L Biotech Co., Ltd. (Deer Field, US). The FDA issued a Cleared decision on June 5, 2006 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 B&L Biotech Co., Ltd. devices

Submission Details

510(k) Number K060347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2006
Decision Date June 05, 2006
Days to Decision 115 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 127d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKR Plugger, Root Canal, Endodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.