Cleared Traditional

K073458 - BT-TITE ONE(BTICV1), BT-TITE STANDARD(BTIVSM), BT-TITE CV2(BTICV2)

K073458 is an FDA 510(k) clearance for BT-TITE ONE(BTICV1), manufactured by Btlock Srl. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K073458 · Btlock Srl · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
116d
Days
Class 2
Risk

K073458 is an FDA 510(k) clearance for the BT-TITE ONE(BTICV1), BT-TITE STANDARD(BTIVSM), BT-TITE CV2(BTICV2). Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Btlock Srl (Vicenza, IT). The FDA issued a Cleared decision on April 4, 2008 after a review of 116 days - within the typical 510(k) review window.

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 Btlock Srl devices

FDA 510(k) Submission Details - K073458

510(k) Number K073458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2007
Decision Date April 04, 2008
Days to Decision 116 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
11d faster than avg
Panel avg: 127d · This submission: 116d
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 935
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K073458.
HG II FIXTURE SYSTEM
K080744 · Osstem Implant Co., Ltd. · Jul 2008
NT/IT SYSTEM
K081078 · Osstem Implant Co., Ltd. · Jul 2008
US/GS ULTRA WIDE SYSTEM
K073465 · Osstem Implant Co., Ltd. · Apr 2008
DENTIS DENTAL IMPLANT SYSTEM
K073486 · Dentis Co., Ltd. · Apr 2008
FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS
K073075 · Dentsply International, Inc. · Mar 2008
BLUE SKY BIO DENTAL IMPLANT SYSTEM
K073713 · Blue Sky Bio, LLC · Mar 2008