Cleared Traditional

K180477 - Straumann PURE Ceramic Implant System

K180477 is the FDA 510(k) clearance for Straumann PURE Ceramic Implant System by Institut Straumann AG. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K180477 · Institut Straumann AG · Dental device
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Jan 2019
Decision
316d
Days
Class 2
Risk

K180477 is an FDA 510(k) clearance for the Straumann PURE Ceramic Implant System. 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 January 4, 2019 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K180477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2018
Decision Date January 04, 2019
Days to Decision 316 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
189d slower than avg
Panel avg: 127d · This submission: 316d
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 M. 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 611
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K180477.
OsseOne Dental Implant System
K182293 · Synoross Dba Osseone · Feb 2019
Ritter Dental Implant System
K180183 · Ritter Implants GmbH CO KG · Jan 2019
MRI Compatibility for Existing Neodent Implant System
K182620 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Jan 2019
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K181703 · Institut Straumann AG · Dec 2018
UV Active Implant System
K182194 · Dio Corporation · Dec 2018
PYRAMIDION Dental Implants and Prostheses
K180859 · Dentack Implants, Ltd. · Dec 2018