Cleared Traditional

K811210 - YOSHIDA-PANOURA 10 (FDA 510(k) Clearance)

K811210 · Kaycor Intl., Ltd. · Dental device
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Aug 1981
Decision
112d
Days
-
Risk

K811210 is an FDA 510(k) clearance for the YOSHIDA-PANOURA 10.

Submitted by Kaycor Intl., Ltd. (Mchenry, US). The FDA issued a Cleared decision on August 24, 1981 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Kaycor Intl., Ltd. devices

Submission Details

510(k) Number K811210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1981
Decision Date August 24, 1981
Days to Decision 112 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 127d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -