Cleared Abbreviated

K092513 - RAINBOW BLOCK

K092513 is an FDA 510(k) clearance for RAINBOW BLOCK, manufactured by Genoss Co., Ltd.. The device is a Class 2 Dental device with product code EIH cleared through the Abbreviated 510(k) pathway after a 53-day FDA review.

K092513 · Genoss Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
53d
Days
Class 2
Risk

K092513 is an FDA 510(k) clearance for the RAINBOW BLOCK. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Genoss Co., Ltd. (Cypress, US). The FDA issued a Cleared decision on October 9, 2009 after a review of 53 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Genoss Co., Ltd. devices

FDA 510(k) Submission Details - K092513

510(k) Number K092513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2009
Decision Date October 09, 2009
Days to Decision 53 days
Submission Type Abbreviated
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
75d faster than avg
Panel avg: 128d · This submission: 53d
Pathway characteristics
Standards-based clearance path.

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 464
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