Cleared Traditional

K153758 - Straumann Bone Level Tapered Implants

K153758 is an FDA 510(k) clearance for Straumann Bone Level Tapered Implants, manufactured by Institut Straumann AG. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K153758 · Institut Straumann AG · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
84d
Days
Class 2
Risk

K153758 is an FDA 510(k) clearance for the Straumann Bone Level Tapered Implants. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Institut Straumann AG (Basel, CH). The FDA issued a Cleared decision on March 23, 2016 after a review of 84 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K153758

510(k) Number K153758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2015
Decision Date March 23, 2016
Days to Decision 84 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
44d faster than avg
Panel avg: 128d · This submission: 84d
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 Consultant

Straumann USA, Inc.
Jennifer Jackson

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 1423
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K153758.
Noris Medical Zygomatic Dental Implant System
K151909 · Noris Medical , Ltd. · Apr 2016
KLOCKNER VEGA DENTAL IMPLANT SYSTEM
K153098 · SOADCO, S.L. · Apr 2016
OneQ-SL s-Clean Implant System
K153639 · Dentis Co., Ltd. · Apr 2016
NobelZygoma 45°
K152093 · Nobel Biocare AB · Mar 2016
Dental Implant System
K152555 · Ariabio International, Inc. · Feb 2016
MOR Implant System
K153173 · Sterngold Dental, LLC · Feb 2016