Cleared Traditional

K112532 - ET II BIO-SA FIXTURE SYSTEM

K112532 is an FDA 510(k) clearance for ET II BIO-SA FIXTURE SYSTEM, manufactured by Hiossen, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 341-day FDA review.

K112532 · Hiossen, Inc. · Dental device
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Aug 2012
Decision
341d
Days
Class 2
Risk

K112532 is an FDA 510(k) clearance for the ET II BIO-SA FIXTURE SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Hiossen, Inc. (Fariless Hills, US). The FDA issued a Cleared decision on August 6, 2012 after a review of 341 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Hiossen, Inc. devices

FDA 510(k) Submission Details - K112532

510(k) Number K112532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2011
Decision Date August 06, 2012
Days to Decision 341 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
214d slower than avg
Panel avg: 127d · This submission: 341d
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 1185
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K112532.
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