Cleared Traditional

K971594 - FLOW-RITE

K971594 is an FDA 510(k) clearance for FLOW-RITE, manufactured by Pulpdent Corp.. The device is a Class 2 Dental device with 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)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K971594

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.

EBF Device Classification - Class 2, Special Controls

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 797
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K971594.
VERSAETCH
K973257 · Centrix, Inc. · Nov 1997
SOLIDEX
K972292 · Shofu Dental Corp. · Oct 1997
CAVIT-LC
K972892 · Espe GmbH & Co. Kg. · Oct 1997
BELLEGLASS HP ENAMEL REPAIR MATERIAL
K971762 · Sybron Dental Specialties, Inc. · Sep 1997
ZENTIH FLOWABLE COMPOSITE (MULTIPLE)
K970683 · Foremost Dental Mfg., Inc. · Jul 1997
PERMALUTE, TRY-IN PASTE
K971898 · Ultradent Products, Inc. · Jun 1997