Cleared Traditional

K022258 - B.T.I. BIOTECHNOLOGY INSTITUTE

K022258 is an FDA 510(k) clearance for B.T.I. BIOTECHNOLOGY INSTITUTE, manufactured by B.T.I. Biotechnology Institute, Sl.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 426-day FDA review.

K022258 · B.T.I. Biotechnology Institute, Sl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
426d
Days
Class 2
Risk

K022258 is an FDA 510(k) clearance for the B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by B.T.I. Biotechnology Institute, Sl. (01510 Minano (Alava), ES). The FDA issued a Cleared decision on September 11, 2003 after a review of 426 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 B.T.I. Biotechnology Institute, Sl. devices

FDA 510(k) Submission Details - K022258

510(k) Number K022258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2002
Decision Date September 11, 2003
Days to Decision 426 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
299d slower than avg
Panel avg: 127d · This submission: 426d
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 759
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K022258.
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