Cleared Traditional

K251297 - MIS LYNX Conical Connection Implant System

K251297 is the FDA 510(k) clearance for MIS LYNX Conical Connection Implant System by Dentsply Sirona, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K251297 · Dentsply Sirona, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
87d
Days
Class 2
Risk

K251297 is an FDA 510(k) clearance for the MIS LYNX Conical Connection Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Dentsply Sirona, Inc. (York, US). The FDA issued a Cleared decision on July 24, 2025 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dentsply Sirona, Inc. devices

Submission Details

510(k) Number K251297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2025
Decision Date July 24, 2025
Days to Decision 87 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
40d faster than avg
Panel avg: 127d · This submission: 87d
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 588
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K251297.
Neodent Implant System - Zirconia Implant System
K250271 · JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. · Aug 2025
S.I.N. Dental Implant System
K251046 · S.I.N. Implant System Ltda · Aug 2025
Straumann® RidgeFit Implants
K250294 · Institut Straumann AG · Aug 2025
SD TL Implant System
K250280 · Arum Dentistry Co., Ltd. · Jul 2025
DESS® Dental Implants
K251280 · Terrats Medical SL · Jul 2025
HEXIM Implant
K243731 · P&A USA · Jul 2025