Cleared Abbreviated

Panthera Dental Milled Bars (K192108) - FDA 510(k) Clearance

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K192108 · Panthera Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
247d
Days
Class 2
Risk

K192108 is an FDA 510(k) clearance for the Panthera Dental Milled Bars. 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 Panthera Dental, Inc. (Quebec City, CA). The FDA issued a Cleared decision on April 8, 2020 after a review of 247 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Panthera Dental, Inc. devices

Submission Details

510(k) Number K192108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2019
Decision Date April 08, 2020
Days to Decision 247 days
Submission Type Abbreviated
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
120d slower than avg
Panel avg: 127d · This submission: 247d
Pathway characteristics
Standards-based clearance path.

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 Peers - NHA Abutment, Implant, Dental, Endosseous

All 318
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K192108.
IBS Implant System II
K200753 · Innobiosurg Co., Ltd. · Jun 2020
UF(II) Bar holder abutment
K193404 · Dio Corporation · May 2020
Custom Legacy and Custom InterActive Titanium Abutments
K192218 · Implant Direct Sybron Manufacturing, LLC · May 2020
Straumann Screw-Retained Abutments
K192401 · Straumann USA, LLC · Apr 2020
Universal Base Conical Connection (CC)
K200040 · Nobel Biocare AG · Mar 2020
MIS CONNECT Conical Connection System
K193078 · Dentsply Sirona · Mar 2020