Cleared Traditional

BITESTRIP (K030869) - FDA 510(k) Clearance

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

K030869 · S.L.P. , Ltd. · Dental device
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May 2004
Decision
422d
Days
Class 2
Risk

K030869 is an FDA 510(k) clearance for the BITESTRIP. Classified as Device, Muscle Monitoring (product code KZM), Class II - Special Controls.

Submitted by S.L.P. , Ltd. (Tel-Aviv, IL). The FDA issued a Cleared decision on May 14, 2004 after a review of 422 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 890.1375 - 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 S.L.P. , Ltd. devices

Submission Details

510(k) Number K030869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2003
Decision Date May 14, 2004
Days to Decision 422 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
295d slower than avg
Panel avg: 127d · This submission: 422d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KZM Device, Muscle Monitoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
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.