Cleared Traditional

K163238 - Eclipse Kiss Zirconia

K163238 is an FDA 510(k) clearance for Eclipse Kiss Zirconia, manufactured by Ams. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K163238 · Ams · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
167d
Days
Class 2
Risk

K163238 is an FDA 510(k) clearance for the Eclipse Kiss Zirconia. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Ams (Gyeonggi-Do, KR). The FDA issued a Cleared decision on May 4, 2017 after a review of 167 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.

FDA 510(k) Submission Details - K163238

510(k) Number K163238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2016
Decision Date May 04, 2017
Days to Decision 167 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
39d slower than avg
Panel avg: 128d · This submission: 167d
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 Consultant

Onbix Corporation
HO DONG YANG

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 - EIH Powder, Porcelain

All 471
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K163238.
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