Cleared Traditional

K100182 - SALVIN DENTAL SPECIALTIES FIXATION SCREW

K100182 is an FDA 510(k) clearance for SALVIN DENTAL SPECIALTIES FIXATION SCREW, 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 109-day FDA review.

K100182 · Salvin Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
109d
Days
Class 2
Risk

K100182 is an FDA 510(k) clearance for the SALVIN DENTAL SPECIALTIES 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 May 10, 2010 after a review of 109 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.

FDA 510(k) Submission Details - K100182

510(k) Number K100182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2010
Decision Date May 10, 2010
Days to Decision 109 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
19d faster than avg
Panel avg: 128d · This submission: 109d
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 80
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K100182.
MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT
K130682 · Hager& Meisinger GmbH · Aug 2013
NEODENT GRAFT SCREW
K103084 · Jjgc Industria E Comercio DE Materiais Dentarios S · Feb 2011
J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030
K101902 · Jeil Medical Corporation · Feb 2011
PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT#
K093719 · Osteogenics Biomedical, Inc. · Mar 2010
RAPIDSORB PLUS SCREW SYSTEM
K093464 · Synthes (Usa) · Jan 2010
MILTEX MEMBRANE TACK KIT
K092855 · Miltex, Inc. · Dec 2009
K100182 · SALVIN DENTAL SPECIALTIES FIXATION SCREW
Download PDF FDA Summary Salvin Dental Special…