Cleared Traditional

K190059 - CEREC Guides

K190059 is an FDA 510(k) clearance for CEREC Guides, manufactured by Dentsply Sirona. The device is a Class 1 Dental device with product code NDP cleared through the Traditional 510(k) pathway after a 259-day FDA review.

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

FDA 510(k) Submission Details - K190059

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.

NDP Device Classification - Class 1, General Controls

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.