Cleared Traditional

K241391 - Straumann PURE Ceramic Implants

K241391 is the FDA 510(k) clearance for Straumann PURE Ceramic Implants by Institut Straumann AG. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K241391 · Institut Straumann AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
209d
Days
Class 2
Risk

K241391 is an FDA 510(k) clearance for the Straumann® PURE Ceramic 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 December 10, 2024 after a review of 209 days - an extended review 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: 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 Institut Straumann AG devices

Submission Details

510(k) Number K241391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2024
Decision Date December 10, 2024
Days to Decision 209 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
82d slower than avg
Panel avg: 127d · This submission: 209d
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 Consultant

Straumann USA, LLC
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 588
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K241391.
Alpha Dent Implants Dental Implants System
K240435 · Alpha Dent Implants GmbH · Dec 2024
Quickdent Dental Implant System
K243094 · Quickdent Devices Private , Ltd. · Dec 2024
Dental Implants and Abutments
K243066 · Ditron Dental, Ltd. · Dec 2024
MIS LYNX Conical Connection Implant System
K241692 · Dentsply Sirona, Inc. · Nov 2024
NUVENTUS NV.C™ Dental Implant System
K233081 · Infinitum Eta, Ltd. · Nov 2024
LL Implant System
K242379 · Ossvis Co., Ltd. · Nov 2024