Cleared Traditional

K063364 - ALPHA BIO DENTAL IMPLANT SYSTEM

K063364 is an FDA 510(k) clearance for ALPHA BIO DENTAL IMPLANT SYSTEM, manufactured by Alpha-Bio Tec , Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K063364 · Alpha-Bio Tec , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
127d
Days
Class 2
Risk

K063364 is an FDA 510(k) clearance for the ALPHA BIO DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Alpha-Bio Tec , Ltd. (Washington, US). The FDA issued a Cleared decision on March 14, 2007 after a review of 127 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 Alpha-Bio Tec , Ltd. devices

FDA 510(k) Submission Details - K063364

510(k) Number K063364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2006
Decision Date March 14, 2007
Days to Decision 127 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
At panel average
Panel avg: 127d · This submission: 127d
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 981
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K063364.
OSSEOTITE
K063286 · Implant Innovations, Inc. · Apr 2007
ZYGOMA IMPLANT (IMMEDIATE FUNCTION)
K070182 · Nobel Biocare AB · Apr 2007
DRILL FOR BLUE SKY BIO DENTAL IMPLANT SYSTEM
K063874 · Blue Sky Bio, LLC · Mar 2007
ZIRCONIA IMPLANT
K061971 · Nobel Biocare AB · Mar 2007
CERTAIN PREVAIL DENTAL IMPLANT
K061629 · Implant Innovations, Inc. · Feb 2007
NANOTITE DENTAL IMPLANTS
K062432 · Implant Innovations, Inc. · Feb 2007