Cleared Traditional

HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P (K102305) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K102305 · Hass Corp. · Dental device
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Dec 2010
Decision
109d
Days
Class 2
Risk

K102305 is an FDA 510(k) clearance for the HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Hass Corp. (Anaheim, US). The FDA issued a Cleared decision on December 3, 2010 after a review of 109 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 Hass Corp. devices

Submission Details

510(k) Number K102305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2010
Decision Date December 03, 2010
Days to Decision 109 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 127d · This submission: 109d
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 Peers - EIH Powder, Porcelain

All 185
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