Cleared Traditional

K954030 - BONE-LOCK

K954030 is an FDA 510(k) clearance for BONE-LOCK, manufactured by Leibinger GmbH. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 809-day FDA review.

K954030 · Leibinger GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
809d
Days
Class 2
Risk

K954030 is an FDA 510(k) clearance for the BONE-LOCK. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Leibinger GmbH (Dallas, US). The FDA issued a Cleared decision on November 14, 1997 after a review of 809 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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 Leibinger GmbH devices

FDA 510(k) Submission Details - K954030

510(k) Number K954030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1995
Decision Date November 14, 1997
Days to Decision 809 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
682d slower than avg
Panel avg: 127d · This submission: 809d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 1245
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