Cleared Traditional

OSTEOMED MSS (K961418) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961418 · Osteomed Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
196d
Days
Class 2
Risk

K961418 is an FDA 510(k) clearance for the OSTEOMED MSS. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Osteomed Corp. (Irving, US). The FDA issued a Cleared decision on October 25, 1996 after a review of 196 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 Osteomed Corp. devices

Submission Details

510(k) Number K961418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1996
Decision Date October 25, 1996
Days to Decision 196 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 127d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 30
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K961418.
SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS
K980199 · Synthes (Usa) · Apr 1998
SMF TITANIUM (TI) ALLOY BONE SCREWS
K963546 · Synthes (Usa) · Jun 1997
SMF STAINLESS STEEL BONE SCREWS
K964261 · Synthes (Usa) · Apr 1997
LEW PROSTHETIC LOCKING DEVICE
K770131 · Howmedica Corp. · Jan 1977
LUHR MANDIBULAR COMPRESSION-SCREW SYSTEM
K761228 · Howmedica Corp. · Dec 1976