Cleared Traditional

Tandry CMF Plate System (K220360) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 95
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K220360.
MedCAD® AccuPlate® 3DTi Patient-Specific Plating System
K230398 · Medcad · Sep 2023
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K230733 · Stryker Leibinger GmbH & Co KG · Aug 2023
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K222650 · Stryker Craniomaxillofacial (Cmf) · Dec 2022
Universal CMF System
K221855 · Stryker Leibinger GmbH & Co KG · Nov 2022
KLS Martin Individual Patient Solutions
K210731 · KLS-Martin L.P. · Jul 2022
Stryker Resorbable Fixation System
K213777 · Stryker Leibinger Micro Implants · Feb 2022