Cleared Traditional

K250763 - Reon (FDA 510(k) Clearance)

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

K250763 · C.E.I.B.Med · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
60d
Days
Class 2
Risk

K250763 is an FDA 510(k) clearance for the Reon. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by C.E.I.B.Med (Seoul-Si, KR). The FDA issued a Cleared decision on May 12, 2025 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.E.I.B.Med devices

Submission Details

510(k) Number K250763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2025
Decision Date May 12, 2025
Days to Decision 60 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
67d faster than avg
Panel avg: 127d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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

GMSC Co., Ltd.
Jong-Hyun Kim

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.

Regulatory Peers - EBF Material, Tooth Shade, Resin

All 926
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K250763.
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