Cleared Traditional

K971594 - FLOW-RITE

K971594 is the FDA 510(k) clearance for FLOW-RITE by Pulpdent Corp.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K971594 · Pulpdent Corp. · Dental device
Download Printable Device Report (PDF)
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Sep 1997
Decision
134d
Days
Class 2
Risk

K971594 is an FDA 510(k) clearance for the FLOW-RITE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on September 12, 1997 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Pulpdent Corp. devices

Submission Details

510(k) Number K971594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1997
Decision Date September 12, 1997
Days to Decision 134 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
7d slower than avg
Panel avg: 127d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBF Material, Tooth Shade, Resin

All 577
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K971594.
EPIC-FLO
K973976 · Parkell, Inc. · Dec 1997
VERSAETCH
K973257 · Centrix, Inc. · Nov 1997
SOLIDEX
K972292 · Shofu Dental Corp. · Oct 1997
BELLEGLASS HP ENAMEL REPAIR MATERIAL
K971762 · Sybron Dental Specialties, Inc. · Sep 1997
PERMALUTE, TRY-IN PASTE
K971898 · Ultradent Products, Inc. · Jun 1997
COMPOGLASS F
K971513 · Ivoclar North America, Inc. · Jun 1997