Cleared Abbreviated

K142987 - DD Bio Z, DD Bio ZX(square), DD BioZX(square) color

K142987 is an FDA 510(k) clearance for DD Bio Z, manufactured by Dental Direkt of Amerika UG (Haftungsbeschraenkt). The device is a Class 2 Dental device with product code EIH cleared through the Abbreviated 510(k) pathway after a 118-day FDA review.

K142987 · Dental Direkt of Amerika UG (Haftungsbeschraenkt) · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
118d
Days
Class 2
Risk

K142987 is an FDA 510(k) clearance for the DD Bio Z, DD Bio ZX(square), DD BioZX(square) color. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Dental Direkt of Amerika UG (Haftungsbeschraenkt) (Spenge, DE). The FDA issued a Cleared decision on February 11, 2015 after a review of 118 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K142987

510(k) Number K142987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2014
Decision Date February 11, 2015
Days to Decision 118 days
Submission Type Abbreviated
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
10d faster than avg
Panel avg: 128d · This submission: 118d
Pathway characteristics
Standards-based clearance path.

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

Dental Direkt GmbH
Uwe Greitens

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 K142987.
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