Cleared Traditional

K980760 - KLS-MARTIN MMF SCREW

K980760 is an FDA 510(k) clearance for KLS-MARTIN MMF SCREW, manufactured by KLS-Martin L.P.. The device is a Class 2 Dental device with product code DZL cleared through the Traditional 510(k) pathway after a 662-day FDA review.

K980760 · KLS-Martin L.P. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
662d
Days
Class 2
Risk

K980760 is an FDA 510(k) clearance for the KLS-MARTIN MMF SCREW. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by KLS-Martin L.P. (New Port Riche, US). The FDA issued a Cleared decision on December 21, 1999 after a review of 662 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all KLS-Martin L.P. devices

FDA 510(k) Submission Details - K980760

510(k) Number K980760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1998
Decision Date December 21, 1999
Days to Decision 662 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
535d slower than avg
Panel avg: 127d · This submission: 662d
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 K980760.
LACTOSORB PUSH SCREW
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IMTEC BIOPIN
K982951 · Imtec Corp. · Jun 1999