Cleared Traditional

K911936 - OSTEOMED SBF SYSTEM (SBF)

K911936 is an FDA 510(k) clearance for OSTEOMED SBF SYSTEM (SBF), manufactured by Osteomed Corp.. The device is a Class 2 Dental device with product code DZL cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K911936 · Osteomed Corp. · Dental device
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Aug 1991
Decision
112d
Days
Class 2
Risk

K911936 is an FDA 510(k) clearance for the OSTEOMED SBF SYSTEM (SBF). Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Osteomed Corp. (Glendale, US). The FDA issued a Cleared decision on August 21, 1991 after a review of 112 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.

View all Osteomed Corp. devices

FDA 510(k) Submission Details - K911936

510(k) Number K911936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1991
Decision Date August 21, 1991
Days to Decision 112 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 127d · This submission: 112d
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 78
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K911936.
IMZ BONE TACK SYSTEM
K952167 · Interpore Intl. · Nov 1995
ACE BONE SCREW TACKING KIT
K951510 · Ace Surgical Supply Co., Inc. · Aug 1995
MEMFIX SCREWS
K910427 · W.L. Gore & Associates, Inc. · Sep 1991
LEW PROSTHETIC LOCKING DEVICE
K770131 · Howmedica Corp. · Jan 1977
LUHR MANDIBULAR COMPRESSION-SCREW SYSTEM
K761228 · Howmedica Corp. · Dec 1976