Cleared Special

K170420 - n!ce Glass Ceramic Blocks for Amann Gir...

K170420 is an FDA 510(k) clearance for n!ce Glass Ceramic Blocks for Amann Gir..., manufactured by Institut Straumann AG. The device is a Class 2 Dental device with product code EIH cleared through the Special 510(k) pathway after a 17-day FDA review.

K170420 · Institut Straumann AG · Dental device
Download Printable Device Report (PDF)
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Mar 2017
Decision
17d
Days
Class 2
Risk

K170420 is an FDA 510(k) clearance for the n!ce Glass Ceramic Blocks for Amann Girrbach. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Institut Straumann AG (Basel, CH). The FDA issued a Cleared decision on March 2, 2017 after a review of 17 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Institut Straumann AG devices

FDA 510(k) Submission Details - K170420

510(k) Number K170420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2017
Decision Date March 02, 2017
Days to Decision 17 days
Submission Type Special
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
110d faster than avg
Panel avg: 127d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

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

Straumann USA, LLC
Jennifer M. Jackson

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 287
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K170420.
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