Cleared Traditional

K861561 - ZEST MARK II (STANDARD & MINI)

K861561 is an FDA 510(k) clearance for ZEST MARK II (STANDARD & MINI), manufactured by Zest Anchors, Inc.. The device is a Class 1 Dental device with product code EGG cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K861561 · Zest Anchors, Inc. · Dental device
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May 1986
Decision
26d
Days
Class 1
Risk

K861561 is an FDA 510(k) clearance for the ZEST MARK II (STANDARD & MINI). Classified as Attachment, Precision, All (product code EGG), Class I - General Controls.

Submitted by Zest Anchors, Inc. (San Diego, US). The FDA issued a Cleared decision on May 21, 1986 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3165 - 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.

FDA 510(k) Submission Details - K861561

510(k) Number K861561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1986
Decision Date May 21, 1986
Days to Decision 26 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
102d faster than avg
Panel avg: 128d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

EGG Device Classification - Class 1, General Controls

Product Code EGG Attachment, Precision, All
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3165
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 - EGG Attachment, Precision, All

All 20
Devices cleared under the same product code (EGG) and FDA review panel - the closest regulatory comparables to K861561.
COSMETIC SINGLE SPAN BRIDGE
K871439 · Cosmetic Dental Technologies, Inc. · Jun 1987
IMZ INTRAMOBILE CYLINDER IMPLANT SYSTEM COMPONENTS
K870331 · Interpore Intl. · Mar 1987
SHINER STRESS DIRECTING ATTACHMENT
K863243 · Js & R - R & D Co. · Oct 1986
DYNA SYSTEM
K855167 · Parker Laboratories, Inc. · Mar 1986
JACKSON RARE EARTH MAGNETIC ATTACHMENT
K854633 · Solid State Innovations, Inc. · Jan 1986
PRECIOUS-METAL/PLASTIC ATTACH., AUXILL
K812360 · Zl-Microdent-Attachments · Sep 1981
K861561 · ZEST MARK II (STANDARD & MINI)
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