Cleared Traditional

K062504 - CERAMAX

K062504 is an FDA 510(k) clearance for CERAMAX, manufactured by Alphadent Co., Ltd.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K062504 · Alphadent Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
8d
Days
Class 2
Risk

K062504 is an FDA 510(k) clearance for the CERAMAX. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Alphadent Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on September 5, 2006 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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 Alphadent Co., Ltd. devices

FDA 510(k) Submission Details - K062504

510(k) Number K062504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2006
Decision Date September 05, 2006
Days to Decision 8 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 127d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

EIH Device Classification - Class 2, Special Controls

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 325
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K062504.
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