Cleared Traditional

K132242 - INNO SLA SUBMERGED IMPLANT SYSTEM

K132242 is an FDA 510(k) clearance for INNO SLA SUBMERGED IMPLANT SYSTEM, manufactured by Cowellmedi Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K132242 · Cowellmedi Co., Ltd. · Dental device
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Dec 2013
Decision
141d
Days
Class 2
Risk

K132242 is an FDA 510(k) clearance for the INNO SLA SUBMERGED IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Cowellmedi Co., Ltd. (Brea, US). The FDA issued a Cleared decision on December 6, 2013 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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 Cowellmedi Co., Ltd. devices

FDA 510(k) Submission Details - K132242

510(k) Number K132242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2013
Decision Date December 06, 2013
Days to Decision 141 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
14d slower than avg
Panel avg: 127d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 759
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