Cleared Traditional

K133733 - WINSIX Implant System

K133733 is an FDA 510(k) clearance for WINSIX Implant System, manufactured by Biosaf IN S.R.L.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 418-day FDA review.

K133733 · Biosaf IN S.R.L. · Dental device
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Jan 2015
Decision
418d
Days
Class 2
Risk

K133733 is an FDA 510(k) clearance for the WINSIX Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Biosaf IN S.R.L. (Imola, IT). The FDA issued a Cleared decision on January 28, 2015 after a review of 418 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Biosaf IN S.R.L. devices

FDA 510(k) Submission Details - K133733

510(k) Number K133733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2013
Decision Date January 28, 2015
Days to Decision 418 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
291d slower than avg
Panel avg: 127d · This submission: 418d
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 839
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K133733.
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K140934 · Hiossen, Inc. · Nov 2014