Cleared Traditional

K160099 - CEREC SpeedGlaze

K160099 is the FDA 510(k) clearance for CEREC SpeedGlaze by Sirona Dental Systems GmbH. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K160099 · Sirona Dental Systems GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
135d
Days
Class 2
Risk

K160099 is an FDA 510(k) clearance for the CEREC SpeedGlaze. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Sirona Dental Systems GmbH (Bensheim, DE). The FDA issued a Cleared decision on June 2, 2016 after a review of 135 days - within the typical 510(k) review window.

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 Sirona Dental Systems GmbH devices

Submission Details

510(k) Number K160099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2016
Decision Date June 02, 2016
Days to Decision 135 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
8d slower than avg
Panel avg: 127d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Sirona Dental Systems, Inc.
Kofi Aninakwa

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.

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