Cleared Traditional

DENTAL IMPLANT SYSTEM 4.0MM AND 5.5MM LENGTH (K912521) - FDA 510(k) Clearance

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

K912521 · Bud Industries, Inc. · Dental device
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May 1995
Decision
1440d
Days
Class 2
Risk

K912521 is an FDA 510(k) clearance for the DENTAL IMPLANT SYSTEM 4.0MM AND 5.5MM LENGTH. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Bud Industries, Inc. (Holland, US). The FDA issued a Cleared decision on May 2, 1995 after a review of 1440 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 Bud Industries, Inc. devices

Submission Details

510(k) Number K912521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1991
Decision Date May 02, 1995
Days to Decision 1440 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1313d slower than avg
Panel avg: 127d · This submission: 1440d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 303
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