Cleared Traditional

K102053 - BUTLER CALCI-FLOR PROPHYLAXIS PASTE (FDA 510(k) Clearance)

Class I Dental device.

K102053 · Sunstar Americas, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
196d
Days
Class 1
Risk

K102053 is an FDA 510(k) clearance for the BUTLER CALCI-FLOR PROPHYLAXIS PASTE. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Sunstar Americas, Inc. (Lake Bluff, US). The FDA issued a Cleared decision on February 3, 2011 after a review of 196 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6030 - 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 Sunstar Americas, Inc. devices

Submission Details

510(k) Number K102053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2010
Decision Date February 03, 2011
Days to Decision 196 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
69d slower than avg
Panel avg: 127d · This submission: 196d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EJR Agent, Polishing, Abrasive, Oral Cavity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6030
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.