Cleared Traditional

K162890 - BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment

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

K162890 · Straumann USA, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Straumann USA, LLC devices

FDA 510(k) Submission Details - K162890

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
Combination Product No
PCCP Authorized No
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.

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 1236
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K162890.
K3PRO Konus Additional Abutments and Implants
K160581 · Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG · Mar 2017
Noris Medical MBI-2mm Dental Implant System
K162308 · Noris Medical , Ltd. · Mar 2017
NobelZygoma 0°
K161598 · Nobel Biocare AB · Mar 2017
Dental Implants OKTAGON Tissue Level and Bone Level
K162073 · Hager& Meisinger GmbH · Feb 2017
UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure
K161987 · Dio Corporation · Feb 2017
IBS Implant System II
K162099 · Innobiosurg Co., Ltd. · Feb 2017