Cleared Traditional

K073342 - SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW

K073342 is an FDA 510(k) clearance for SALVIN DENTAL SPECIALTIES, manufactured by Salvin Dental Specialties, Inc.. The device is a Class 2 Dental device with product code DZL cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K073342 · Salvin Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
119d
Days
Class 2
Risk

K073342 is an FDA 510(k) clearance for the SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Salvin Dental Specialties, Inc. (Charlotte, US). The FDA issued a Cleared decision on March 26, 2008 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4880 - 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 Salvin Dental Specialties, Inc. devices

FDA 510(k) Submission Details - K073342

510(k) Number K073342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2007
Decision Date March 26, 2008
Days to Decision 119 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
8d faster than avg
Panel avg: 127d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZL Device Classification - Class 2, Special Controls

Product Code DZL Screw, Fixation, Intraosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4880
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 - DZL Screw, Fixation, Intraosseous

All 62
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