Cleared Traditional

K071615 - FIXAFLOSS

K071615 is an FDA 510(k) clearance for FIXAFLOSS, manufactured by Sybron Dental Specialties, Inc.. The device is a Class 1 Dental device with product code EEF cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K071615 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
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Sep 2007
Decision
100d
Days
Class 1
Risk

K071615 is an FDA 510(k) clearance for the FIXAFLOSS. Classified as Clamp, Rubber Dam (product code EEF), Class I - General Controls.

Submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on September 21, 2007 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6300 - 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 Sybron Dental Specialties, Inc. devices

FDA 510(k) Submission Details - K071615

510(k) Number K071615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2007
Decision Date September 21, 2007
Days to Decision 100 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
27d faster than avg
Panel avg: 127d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

EEF Device Classification - Class 1, General Controls

Product Code EEF Clamp, Rubber Dam
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6300
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.