Cleared Traditional

K091387 - BTI DENTAL IMPLANT 5.5-6.5

K091387 is an FDA 510(k) clearance for BTI DENTAL IMPLANT 5.5-6.5, 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 256-day FDA review.

K091387 · B.T.I. Biotechnology Institute, Sl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
256d
Days
Class 2
Risk

K091387 is an FDA 510(k) clearance for the BTI DENTAL IMPLANT 5.5-6.5. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by B.T.I. Biotechnology Institute, Sl. (Minano Menor, Alava, ES). The FDA issued a Cleared decision on January 22, 2010 after a review of 256 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all B.T.I. Biotechnology Institute, Sl. devices

FDA 510(k) Submission Details - K091387

510(k) Number K091387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2009
Decision Date January 22, 2010
Days to Decision 256 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
129d slower than avg
Panel avg: 127d · This submission: 256d
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 K091387.
GS III SYSTEM
K091208 · Osstem Implant Co., Ltd. · Mar 2010
HG II SHORT FIXTURE SYSTEM
K091678 · Osstem Implant Co., Ltd. · Feb 2010
STRAUMANN RC TEMPORARY ABUTMENTS
K093027 · Straumann USA · Feb 2010
3.25 SPLINE TWIST IMPLANT, HA COATED
K093164 · Zimmer Dental, Inc. · Dec 2009
HG III FIXTURE SYSTEM
K093352 · Hiossen, Inc. · Nov 2009
SPI DENTAL IMPLANT INICELL
K090154 · Thommen Medical AG · Jul 2009