Cleared Abbreviated

K093748 - DD BIO Z AND DD BIO Z - TRANSPA

K093748 is an FDA 510(k) clearance for DD BIO Z AND DD BIO Z - TRANSPA, 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 82-day FDA review.

K093748 · 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 2010
Decision
82d
Days
Class 2
Risk

K093748 is an FDA 510(k) clearance for the DD BIO Z AND DD BIO Z - TRANSPA. 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 24, 2010 after a review of 82 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. 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 - K093748

510(k) Number K093748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2009
Decision Date February 24, 2010
Days to Decision 82 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
46d faster than avg
Panel avg: 128d · This submission: 82d
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 Peers - EIH Powder, Porcelain

All 471
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K093748.
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