Cleared Traditional

K162890 - BLT 02.9mm SC

K162890 is the FDA 510(k) clearance for BLT 02.9mm SC by Straumann USA, LLC. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K162890 · Straumann USA, LLC · Dental device
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Mar 2017
Decision
142d
Days
Class 2
Risk

K162890 is an FDA 510(k) clearance for the BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutme.... Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Straumann USA, LLC (Andover, US). The FDA issued a Cleared decision on March 8, 2017 after a review of 142 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.

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Submission Details

510(k) Number K162890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2016
Decision Date March 08, 2017
Days to Decision 142 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
15d slower than avg
Panel avg: 127d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 673
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