Cleared Traditional

SIALO DRAIN (K072334) - FDA 510(k) Clearance

Class I Dental device.

K072334 · Sialo Technology, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
333d
Days
Class 1
Risk

K072334 is an FDA 510(k) clearance for the SIALO DRAIN. Classified as Catheter, Drainage, Intraoral/extraoral (product code OAJ), Class I - General Controls.

Submitted by Sialo Technology, Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on July 18, 2008 after a review of 333 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 878.4200 - 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. Elevated predicate reliance profile. 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 Sialo Technology, Ltd. devices

Submission Details

510(k) Number K072334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2007
Decision Date July 18, 2008
Days to Decision 333 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
206d slower than avg
Panel avg: 127d · This submission: 333d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OAJ Catheter, Drainage, Intraoral/extraoral
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
Definition To Allow Continuous Drainage Of Saliva And/or Fluid Irrigation Of The Salivary Duct As Well As Assisting In Maintaining Duct Patency During The Healing Process Following Removal Of Salivary Gland Stones For Temporary Insertion Into The Salivary Gland, Whether Orally Or Through The Cheek Following Endoscopic Or Surgical Removal Of Salivary Gland Stones
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.