Cleared Traditional

K002935 - SYNTHES 1.5MM TI BROW LIFT SCREW

K002935 is the FDA 510(k) clearance for SYNTHES 1.5MM TI BROW LIFT SCREW by Synthes (Usa). It is a Class 2 Dental device (product code DZL) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K002935 · Synthes (Usa) · Dental device
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Nov 2000
Decision
56d
Days
Class 2
Risk

K002935 is an FDA 510(k) clearance for the SYNTHES 1.5MM TI BROW LIFT SCREW. 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 November 16, 2000 after a review of 56 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 Synthes (Usa) devices

Submission Details

510(k) Number K002935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2000
Decision Date November 16, 2000
Days to Decision 56 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
71d faster than avg
Panel avg: 127d · This submission: 56d
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 41
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K002935.
THE AUTOTAC SYSTEM
K011675 · BioHorizons Implant Systems, Inc. · Jun 2001
SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR
K010690 · Synthes (Usa) · May 2001
SYNTHES (USA) IMF SCREWS
K010527 · Synthes (Usa) · Apr 2001
LACTOSORB PUSH SCREW
K002423 · Biomet, Inc. · Oct 2000
THE AUTOTAC SYSTEM
K993493 · BioHorizons Implant Systems, Inc. · Jan 2000
KLS-MARTIN MMF SCREW
K980760 · KLS-Martin L.P. · Dec 1999