Cleared Traditional

K850906 - TACTILE PLUS DENTAL ELEVATORS

K850906 is an FDA 510(k) clearance for TACTILE PLUS DENTAL ELEVATORS, manufactured by Ipco Corp.. The device is a Class 1 Dental device with product code EMJ cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K850906 · Ipco Corp. · Dental device
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Apr 1985
Decision
38d
Days
Class 1
Risk

K850906 is an FDA 510(k) clearance for the TACTILE PLUS DENTAL ELEVATORS. Classified as Elevator, Surgical, Dental (product code EMJ), Class I - General Controls.

Submitted by Ipco Corp. (White Plains, US). The FDA issued a Cleared decision on April 12, 1985 after a review of 38 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 Ipco Corp. devices

FDA 510(k) Submission Details - K850906

510(k) Number K850906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1985
Decision Date April 12, 1985
Days to Decision 38 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
89d faster than avg
Panel avg: 127d · This submission: 38d
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 K850906.
ELEVATOR, ROOT, SINGLE-ENDED
K870589 · Military Engineering, Inc. · Apr 1987
880/1 TO 890/4 VARIOUS TYPES OF PERIOTEAL ELEVATOR
K851717 · Artiberia · Jun 1985
680/1 TO 785/2 VARIOUS TYPES & SIZES OF ROOT ELEVA
K851713 · Artiberia · Jun 1985
BEACH DERIOSTEAL ELEVATOR, #2 STRAIGHT
K821788 · Pacific Dental Corp. · Jul 1982
PERIOSTEAL ELEVATOR
K771747 · Depuy, Inc. · Sep 1977