Cleared Traditional

K092530 - SPRYTIE, MODELS ST001, ST002 AND ST003

K092530 is an FDA 510(k) clearance for SPRYTIE, manufactured by Russell B. Walther. The device is a Class 2 Dental device with product code DZK cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K092530 · Russell B. Walther · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
227d
Days
Class 2
Risk

K092530 is an FDA 510(k) clearance for the SPRYTIE, MODELS ST001, ST002 AND ST003. Classified as Wire, Fixation, Intraosseous (product code DZK), Class II - Special Controls.

Submitted by Russell B. Walther (Dallas, US). The FDA issued a Cleared decision on April 2, 2010 after a review of 227 days - an extended review cycle.

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 Russell B. Walther devices

FDA 510(k) Submission Details - K092530

510(k) Number K092530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2009
Decision Date April 02, 2010
Days to Decision 227 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
100d slower than avg
Panel avg: 127d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZK Device Classification - Class 2, Special Controls

Product Code DZK Wire, 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.