Cleared Traditional

K190059 - CEREC Guides (FDA 510(k) Clearance)

Class I Dental device.

K190059 · Dentsply Sirona · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
259d
Days
Class 1
Risk

K190059 is an FDA 510(k) clearance for the CEREC Guides. 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 27, 2019 after a review of 259 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 K190059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2019
Decision Date September 27, 2019
Days to Decision 259 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
132d slower than avg
Panel avg: 127d · This submission: 259d
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.