Cleared Traditional

K811210 - YOSHIDA-PANOURA 10

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.

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FDA 510(k) Submission Details - K811210

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 - Class ,

Product Code -
Device Class -