Cleared Traditional

K851710 - 586 TO 596 VARIOUS TYPES DENTAL ROOT SPLINTER FORC (FDA 510(k) Clearance)

Class I Dental device.

K851710 · Artiberia · Dental device
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Jun 1985
Decision
47d
Days
Class 1
Risk

K851710 is an FDA 510(k) clearance for the 586 TO 596 VARIOUS TYPES DENTAL ROOT SPLINTER FORC. Classified as Forceps, Rongeur, Surgical (product code EMH), Class I - General Controls.

Submitted by Artiberia (San Antonio, US). The FDA issued a Cleared decision on June 11, 1985 after a review of 47 days - a notably fast clearance cycle.

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: 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 Artiberia devices

Submission Details

510(k) Number K851710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1985
Decision Date June 11, 1985
Days to Decision 47 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 127d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EMH Forceps, Rongeur, Surgical
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.