Cleared Traditional

K963546 - SMF TITANIUM (TI) ALLOY BONE SCREWS

K963546 is an FDA 510(k) clearance for SMF TITANIUM (TI) ALLOY BONE SCREWS, manufactured by Synthes (Usa). The device is a Class 2 Dental device with product code DZL cleared through the Traditional 510(k) pathway after a 292-day FDA review.

K963546 · Synthes (Usa) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
292d
Days
Class 2
Risk

K963546 is an FDA 510(k) clearance for the SMF TITANIUM (TI) ALLOY BONE 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 24, 1997 after a review of 292 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K963546

510(k) Number K963546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1996
Decision Date June 24, 1997
Days to Decision 292 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
165d slower than avg
Panel avg: 127d · This submission: 292d
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 73
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K963546.
IMTEC BONE TAC
K973180 · Imtec Corp. · Nov 1997
BONE GRAFT SCREW SYSTEM
K973056 · Bicon, Inc. · Nov 1997
OSTEOMED QUICKFIX
K962774 · Osteomed Corp. · Oct 1997
SMF STAINLESS STEEL BONE SCREWS
K964261 · Synthes (Usa) · Apr 1997
OSTEOMED MSS
K961418 · Osteomed Corp. · Oct 1996
IMZ MEMBRANE TACK SYSTEM
K960945 · Interpore Intl. · May 1996