Cleared Traditional

K151328 - PURE Ceramic Implants

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

K151328 · Straumann USA · Dental device
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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

Submission Details

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.

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 672
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K151328.
OneQ-SL s-Clean Implant System
K153639 · Dentis Co., Ltd. · Apr 2016
Straumann Bone Level Tapered Implants
K153758 · Institut Straumann AG · Mar 2016
NobelZygoma 45°
K152093 · Nobel Biocare AB · Mar 2016
OneQ-SL Implant System
K142313 · Dentis Co., Ltd. · Dec 2015
Dentis Dental Implant System
K150344 · Dentis Co., Ltd. · Jul 2015
MiNi Internal Implant System
K150537 · Megagen Implant Co., Ltd. · Jul 2015