Cleared Traditional

K042048 - GELATO PROPHYLAXIS PASTE

K042048 is an FDA 510(k) clearance for GELATO PROPHYLAXIS PASTE, manufactured by Deepak Products, Inc.. The device is a Class 1 Dental device with product code EJR cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K042048 · Deepak Products, Inc. · Dental device
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Oct 2004
Decision
88d
Days
Class 1
Risk

K042048 is an FDA 510(k) clearance for the GELATO PROPHYLAXIS PASTE. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Deepak Products, Inc. (Miami, US). The FDA issued a Cleared decision on October 26, 2004 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K042048

510(k) Number K042048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2004
Decision Date October 26, 2004
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 128d · This submission: 88d
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 72
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K042048.
GC MI PASTE PLUS
K070854 · GC America, Inc. · Apr 2007
OSSPRAY CLEANING COMPOUND
K062502 · Ospray, Ltd. · Dec 2006
ENAMEL PRO
K062166 · Premier Dental Products Co. · Nov 2006
MI PASTE
K042200 · GC America, Inc. · Oct 2004
BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN
K041371 · Novamin Technology, Inc. · Aug 2004
ZIRCON-F PROPHYLAXIS PASTE
K040988 · Pascal Co., Inc. · Jul 2004
K042048 · GELATO PROPHYLAXIS PASTE
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