Cleared Traditional

KLS-MARTIN TEMPORARY CONDYLAR IMPLANT (K990667) - FDA 510(k) Clearance

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

K990667 · KLS-Martin L.P. · Dental device
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Jul 2001
Decision
878d
Days
Class 2
Risk

K990667 is an FDA 510(k) clearance for the KLS-MARTIN TEMPORARY CONDYLAR IMPLANT. Classified as Prosthesis, Condyle, Mandibular, Temporary (product code NEI), Class II - Special Controls.

Submitted by KLS-Martin L.P. (New Port Riche, US). The FDA issued a Cleared decision on July 27, 2001 after a review of 878 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4770 - 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

Submission Details

510(k) Number K990667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1999
Decision Date July 27, 2001
Days to Decision 878 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
751d slower than avg
Panel avg: 127d · This submission: 878d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NEI Prosthesis, Condyle, Mandibular, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4770
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.