Alpha Bio Dental Implant System

FDA 510(k) K063364 · Alpha-Bio Tec , Ltd.

Substantially Equivalent

510(k) numberK063364

Submission

Device name
Alpha Bio Dental Implant System
Applicant
Alpha-Bio Tec , Ltd.
Washington, DC, US
Received
November 7, 2006
Decision date
March 14, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DZE – Implant, Endosseous, Root-Form
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3640
Specialty
Dental
Implant
Yes

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K252031Adin Long Dental Implant SystemDZE · Traditional Adin Dental Implant Systems , Ltd.03/23/2026SE
K253334ZENEX Implant System_Short (R-System)DZE · Traditional Izenimplant Co., Ltd.03/16/2026SE
K252168Straumann® BLC Implants - Indication WideningDZE · Traditional Institut Straumann AG03/10/2026SE
K253493Dentis SQ-SL AXEL FixtureDZE · Traditional Dentis Co., Ltd.03/04/2026SE

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Questions and answers

When was Alpha Bio Dental Implant System cleared by the FDA?

Alpha Bio Dental Implant System (K063364) received a 510(k) decision of Substantially Equivalent on March 14, 2007, 127 days after the submission was received.

What is the product code of K063364?

The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.