Cleared Traditional

K220360 - Tandry CMF Plate System

K220360 is an FDA 510(k) clearance for Tandry CMF Plate System, manufactured by Microware Precision Co., Ltd.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K220360 · Microware Precision Co., Ltd. · Dental device
Download Printable Device Report (PDF)
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Nov 2022
Decision
275d
Days
Class 2
Risk

K220360 is an FDA 510(k) clearance for the Tandry CMF Plate System. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Microware Precision Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on November 10, 2022 after a review of 275 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - 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: 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 Microware Precision Co., Ltd. devices

FDA 510(k) Submission Details - K220360

510(k) Number K220360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2022
Decision Date November 10, 2022
Days to Decision 275 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 127d · This submission: 275d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - JEY Plate, Bone

All 193
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K220360.
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