Cleared Traditional

K162261 - CERAMAGE UP

K162261 is an FDA 510(k) clearance for CERAMAGE UP, manufactured by Shofu Dental Corporation. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K162261 · Shofu Dental Corporation · Dental device
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Jan 2017
Decision
153d
Days
Class 2
Risk

K162261 is an FDA 510(k) clearance for the CERAMAGE UP. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on January 11, 2017 after a review of 153 days - an extended review 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: 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 Shofu Dental Corporation devices

FDA 510(k) Submission Details - K162261

510(k) Number K162261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2016
Decision Date January 11, 2017
Days to Decision 153 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 127d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

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 Peers - EBF Material, Tooth Shade, Resin

All 782
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K162261.
MAZIC Duro
K163346 · Vericom Co., Ltd. · Mar 2017
Renamel NANO +plus
K163480 · Cosmedent, Inc. · Feb 2017
Tooth Shade Resin Material
K162323 · Liaoning Upcera Co., Ltd. · Jan 2017
Filtek One Bulk Fill Restorative
K163207 · 3M Company · Nov 2016
CAD/CAMouflage Milling Block
K162537 · Prismatik Dentalcraft, Inc. · Nov 2016
Charisma
K160049 · Heraeus Kulzer, LLC, Mitsui Chemicals Group · Nov 2016