Cleared Traditional

K102053 - BUTLER CALCI-FLOR PROPHYLAXIS PASTE

K102053 is an FDA 510(k) clearance for BUTLER CALCI-FLOR PROPHYLAXIS PASTE, manufactured by Sunstar Americas, Inc.. The device is a Class 1 Dental device with product code EJR cleared through the Traditional 510(k) pathway after a 196-day FDA review.

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

FDA 510(k) Submission Details - K102053

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.

EJR Device Classification - Class 1, General Controls

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.

Regulatory Peers - EJR Agent, Polishing, Abrasive, Oral Cavity

All 31
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K102053.
AIR-FLOW PLUS Prophylaxis powder
K171189 · E.M.S Electro Medical Systems S.A · Sep 2017
NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN
K121698 · Dentsply International, Inc. · Aug 2012
REMIN PRO
K101104 · Voco GmbH · Oct 2010
GC MI PASTE PLUS
K070854 · GC America, Inc. · Apr 2007
ENAMEL PRO
K062166 · Premier Dental Products Co. · Nov 2006
MI PASTE
K042200 · GC America, Inc. · Oct 2004