Cleared Abbreviated

K133362 - SGS DENTAL IMPLANT

K133362 is an FDA 510(k) clearance for SGS DENTAL IMPLANT, manufactured by Sgs International, Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Abbreviated 510(k) pathway after a 385-day FDA review.

K133362 · Sgs International, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2014
Decision
385d
Days
Class 2
Risk

K133362 is an FDA 510(k) clearance for the SGS DENTAL IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Sgs International, Ltd. (Woodland Hills, US). The FDA issued a Cleared decision on November 21, 2014 after a review of 385 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Sgs International, Ltd. devices

FDA 510(k) Submission Details - K133362

510(k) Number K133362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2013
Decision Date November 21, 2014
Days to Decision 385 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
258d slower than avg
Panel avg: 127d · This submission: 385d
Pathway characteristics
Standards-based clearance path.

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 840
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K133362.
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K140878 · Straumann USA, LLC · Aug 2014