Cleared Traditional

K851713 - 680/1 TO 785/2 VARIOUS TYPES & SIZES OF ROOT ELEVA

K851713 is an FDA 510(k) clearance for 680/1 TO 785/2 VARIOUS TYPES & SIZES OF..., manufactured by Artiberia. The device is a Class 1 Dental device with product code EMJ cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K851713 · Artiberia · Dental device
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Jun 1985
Decision
47d
Days
Class 1
Risk

K851713 is an FDA 510(k) clearance for the 680/1 TO 785/2 VARIOUS TYPES & SIZES OF ROOT ELEVA. Classified as Elevator, Surgical, Dental (product code EMJ), 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 - K851713

510(k) Number K851713 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
81d faster than avg
Panel avg: 128d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

EMJ Device Classification - Class 1, General Controls

Product Code EMJ Elevator, Surgical, Dental
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 - EMJ Elevator, Surgical, Dental

Devices cleared under the same product code (EMJ) and FDA review panel - the closest regulatory comparables to K851713.
ELEVATOR, ROOT, SINGLE-ENDED
K870589 · Military Engineering, Inc. · Apr 1987
880/1 TO 890/4 VARIOUS TYPES OF PERIOTEAL ELEVATOR
K851717 · Artiberia · Jun 1985
TACTILE PLUS DENTAL ELEVATORS
K850906 · Ipco Corp. · Apr 1985
BEACH DERIOSTEAL ELEVATOR, #2 STRAIGHT
K821788 · Pacific Dental Corp. · Jul 1982
PERIOSTEAL ELEVATOR
K771747 · Depuy, Inc. · Sep 1977