Cleared Traditional

K151328 - PURE Ceramic Implants

K151328 is an FDA 510(k) clearance for PURE Ceramic Implants, manufactured by Straumann USA. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K151328 · Straumann USA · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
238d
Days
Class 2
Risk

K151328 is an FDA 510(k) clearance for the PURE Ceramic Implants. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Straumann USA (Andover, US). The FDA issued a Cleared decision on January 11, 2016 after a review of 238 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 Straumann USA devices

FDA 510(k) Submission Details - K151328

510(k) Number K151328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2015
Decision Date January 11, 2016
Days to Decision 238 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
111d slower than avg
Panel avg: 127d · This submission: 238d
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 K151328.
MOR Implant System
K153173 · Sterngold Dental, LLC · Feb 2016
QUAD Dental Implants and Prostheses
K152188 · Dentack Impants, Ltd. · Jan 2016
Magicore System
K152520 · Innobiosurg Co., Ltd. · Jan 2016
TRI Dental Implant System
K151916 · Tri Dental Implants Int. AG · Dec 2015
OneQ-SL Implant System
K142313 · Dentis Co., Ltd. · Dec 2015
3i T3 Short Implants
K150571 · Biomet 3i · Nov 2015