Cleared Traditional

K232889 - METICULY Patient-specific titanium maxi...

K232889 is an FDA 510(k) clearance for METICULY Patient-specific titanium maxi..., manufactured by Meticuly Co., Ltd.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K232889 · Meticuly Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
225d
Days
Class 2
Risk

K232889 is an FDA 510(k) clearance for the METICULY Patient-specific titanium maxillofacial mesh implant. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Meticuly Co., Ltd. (Bangkok, TH). The FDA issued a Cleared decision on April 30, 2024 after a review of 225 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 Meticuly Co., Ltd. devices

FDA 510(k) Submission Details - K232889

510(k) Number K232889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2023
Decision Date April 30, 2024
Days to Decision 225 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
98d slower than avg
Panel avg: 127d · This submission: 225d
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 Consultant

Mdr Solutions Co., Ltd.
Paweena U-Thainual

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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