Cleared Traditional

K851710 - 586 TO 596 VARIOUS TYPES DENTAL ROOT SP...

K851710 is an FDA 510(k) clearance for 586 TO 596 VARIOUS TYPES DENTAL ROOT SP..., manufactured by Artiberia. The device is a Class 1 Dental device with product code EMH cleared through the Traditional 510(k) pathway after a 47-day FDA review.

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

FDA 510(k) Submission Details - K851710

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 127d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

EMH Device Classification - Class 1, General Controls

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.

Regulatory Peers - EMH Forceps, Rongeur, Surgical

Devices cleared under the same product code (EMH) and FDA review panel - the closest regulatory comparables to K851710.
BONE RONGEUR, SINGLE-ACTION
K890255 · Kinetic Medical Products · Jan 1989
BONE RONGEUR, DOUBLE-ACTION
K890256 · Kinetic Medical Products · Jan 1989
MANU/SURG INST/ACCESS WUERZBURG TIT MINI BONE PLAT
K854887 · Walter Lorenz Surgical, Inc. · Feb 1986
JAKOBI SURG. INSTRUMENTS #8 15
K834190 · Imm Enterprises , Ltd. · Mar 1984
MODIFIED RONGEURS FOR SPINAL & ORTH. S.
K821358 · Downs Surgical , Ltd. · May 1982
FORCEPS, STYLE #849
K771522 · Premier Dental Products Co. · Aug 1977