Cleared Traditional

K241579 - DD Hybridlayer (multicolored zirconia)

K241579 is an FDA 510(k) clearance for DD Hybridlayer (multicolored zirconia), manufactured by Dental Direkt GmbH. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K241579 · Dental Direkt GmbH · Dental device
Download Printable Device Report (PDF)
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Sep 2024
Decision
95d
Days
Class 2
Risk

K241579 is an FDA 510(k) clearance for the DD Hybridlayer (multicolored zirconia). Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Dental Direkt GmbH (Spenge, DE). The FDA issued a Cleared decision on September 6, 2024 after a review of 95 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 Dental Direkt GmbH devices

FDA 510(k) Submission Details - K241579

510(k) Number K241579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2024
Decision Date September 06, 2024
Days to Decision 95 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
32d faster than avg
Panel avg: 127d · This submission: 95d
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 Peers - EIH Powder, Porcelain

All 285
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K241579.
Dental porcelain powder
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K241602 · Hunan Qinghao Puzhong Technology Co., Ltd. · Aug 2024
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K241557 · Dentsply Sirona · Aug 2024
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K241715 · Aidite (Qinhuangdao) Technology Co., Ltd. · Jul 2024