Cleared Traditional

K170849 - SIMPLANT Guide (FDA 510(k) Clearance)

Class I Dental device.

K170849 · Dentsply Sirona · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
85d
Days
Class 1
Risk

K170849 is an FDA 510(k) clearance for the SIMPLANT Guide. Classified as Accessories, Implant, Dental, Endosseous (product code NDP), Class I - General Controls.

Submitted by Dentsply Sirona (York, US). The FDA issued a Cleared decision on June 15, 2017 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3980 - 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 devices

Submission Details

510(k) Number K170849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2017
Decision Date June 15, 2017
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 127d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NDP Accessories, Implant, Dental, Endosseous
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3980
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.