Cleared Traditional

K955140 - 2.0 X 6MM SCREW

K955140 is an FDA 510(k) clearance for 2.0 X 6MM SCREW, manufactured by Brasseler USA I, L.P.. The device is a Class 2 Dental device with product code DZL cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K955140 · Brasseler USA I, L.P. · Dental device
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Jan 1996
Decision
53d
Days
Class 2
Risk

K955140 is an FDA 510(k) clearance for the 2.0 X 6MM SCREW. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Brasseler USA I, L.P. (Savannah, US). The FDA issued a Cleared decision on January 5, 1996 after a review of 53 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Brasseler USA I, L.P. devices

FDA 510(k) Submission Details - K955140

510(k) Number K955140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1995
Decision Date January 05, 1996
Days to Decision 53 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
74d faster than avg
Panel avg: 127d · This submission: 53d
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 64
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K955140.
OSTEOMED MSS
K961418 · Osteomed Corp. · Oct 1996
IMZ MEMBRANE TACK SYSTEM
K960945 · Interpore Intl. · May 1996
MEMFIX
K955369 · The Straumann Co. · Jan 1996
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