Cleared Traditional

K770469 - CUTTER TUNGSTEN CARBIDE BURS

K770469 is an FDA 510(k) clearance for CUTTER TUNGSTEN CARBIDE BURS, manufactured by Cutter Laboratories, Inc.. The device is a Class 1 Dental device with product code EJL cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K770469 · Cutter Laboratories, Inc. · Dental device
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Mar 1977
Decision
6d
Days
Class 1
Risk

K770469 is an FDA 510(k) clearance for the CUTTER TUNGSTEN CARBIDE BURS. Classified as Bur, Dental (product code EJL), Class I - General Controls.

Submitted by Cutter Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 16, 1977 after a review of 6 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3240 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cutter Laboratories, Inc. devices

FDA 510(k) Submission Details - K770469

510(k) Number K770469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1977
Decision Date March 16, 1977
Days to Decision 6 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 127d · This submission: 6d
Pathway characteristics
Predicate-based equivalence.

EJL Device Classification - Class 1, General Controls

Product Code EJL Bur, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3240
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.