Cleared Traditional

K193405 - Simplant Digital Guide (FDA 510(k) Clearance)

Class I Dental device.

K193405 · Dentsply Sirona · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2020
Decision
268d
Days
Class 1
Risk

K193405 is an FDA 510(k) clearance for the Simplant Digital 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 September 2, 2020 after a review of 268 days - an extended review 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: 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 Dentsply Sirona devices

Submission Details

510(k) Number K193405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2019
Decision Date September 02, 2020
Days to Decision 268 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
141d slower than avg
Panel avg: 127d · This submission: 268d
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.