Cleared Traditional

K190654 - Straumann CI RD Ceramic Healing Caps

K190654 is the FDA 510(k) clearance for Straumann CI RD Ceramic Healing Caps by Institut Straumann AG. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K190654 · Institut Straumann AG · Dental device
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Jun 2019
Decision
106d
Days
Class 2
Risk

K190654 is an FDA 510(k) clearance for the Straumann CI RD Ceramic Healing Caps. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Institut Straumann AG (Basel, CH). The FDA issued a Cleared decision on June 28, 2019 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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 K190654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2019
Decision Date June 28, 2019
Days to Decision 106 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
21d faster than avg
Panel avg: 127d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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 - NHA Abutment, Implant, Dental, Endosseous

All 463
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K190654.
Osstem Abutment System
K182091 · Osstem Implant Co., Ltd. · Jul 2019
Conometric Abutments
K183079 · Dentsply Sirona, Inc. · Jul 2019
Certain BellaTek Express and BellaTek Flex Abutments
K183138 · Biomet 3i · Jul 2019
Straumann CARES Screw-Retained Bridges and Bars
K190097 · Institut Straumann AG · Jun 2019
Elos Accurate® Customized Abutment
K190299 · Elos Medtech Pinol A/S · Jun 2019
Panthera Dental Milled Bars
K183580 · Panthera Dental, Inc. · Jun 2019