Cleared Traditional

K161857 - Salvin Tenting Screw System

K161857 is an FDA 510(k) clearance for Salvin Tenting Screw System, manufactured by Salvin Dental Specialties. The device is a Class 2 Dental device with product code DZL cleared through the Traditional 510(k) pathway after a 296-day FDA review.

K161857 · Salvin Dental Specialties · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
296d
Days
Class 2
Risk

K161857 is an FDA 510(k) clearance for the Salvin Tenting Screw System. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Salvin Dental Specialties (Charlotte, US). The FDA issued a Cleared decision on April 28, 2017 after a review of 296 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.

FDA 510(k) Submission Details - K161857

510(k) Number K161857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2016
Decision Date April 28, 2017
Days to Decision 296 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
168d slower than avg
Panel avg: 128d · This submission: 296d
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 Consultant

Kapstone Medical, LLC
John Kapitan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DZL Screw, Fixation, Intraosseous

All 79
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K161857.
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K151195 · Osteomed · Sep 2015