Cleared Special

K021850 - SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS (FDA 510(k) Clearance)

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K021850 · Synthes (Usa) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
5d
Days
Class 2
Risk

K021850 is an FDA 510(k) clearance for the SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on June 10, 2002 after a review of 5 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4880 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Synthes (Usa) devices

Submission Details

510(k) Number K021850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2002
Decision Date June 10, 2002
Days to Decision 5 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 127d · This submission: 5d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 79
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K021850.
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