Cleared Traditional

K163251 - Life Essence Universal Porcelain System

K163251 is an FDA 510(k) clearance for Life Essence Universal Porcelain System, manufactured by Blue Sky Bio. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K163251 · Blue Sky Bio · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
259d
Days
Class 2
Risk

K163251 is an FDA 510(k) clearance for the Life Essence Universal Porcelain System. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Blue Sky Bio (Grayslake, US). The FDA issued a Cleared decision on August 4, 2017 after a review of 259 days - an extended review 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: 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 Blue Sky Bio devices

FDA 510(k) Submission Details - K163251

510(k) Number K163251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2016
Decision Date August 04, 2017
Days to Decision 259 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 127d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 286
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