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FDA 510(k)

ALPHA BIO DENTAL IMPLANT SYSTEM

K-Number: K063364 · 2007-03-14

ApplicantAlpha-Bio Tec , Ltd.
Decision Date2007-03-14
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALPHA BIO DENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alpha-Bio Tec , Ltd.. It received FDA 510(k) clearance on 2007-03-14 under 510(k) number K063364. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHA BIO DENTAL IMPLANT SYSTEM?

ALPHA BIO DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2007-03-14. The listed applicant is Alpha-Bio Tec , Ltd.. The 510(k) number is K063364.

When did ALPHA BIO DENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

ALPHA BIO DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 2007-03-14, under 510(k) number K063364.

Who is the listed applicant for ALPHA BIO DENTAL IMPLANT SYSTEM?

The FDA 510(k) record lists Alpha-Bio Tec , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALPHA BIO DENTAL IMPLANT SYSTEM?

The FDA product code for ALPHA BIO DENTAL IMPLANT SYSTEM is DZE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Alpha-Bio Tec , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K063769ALPHA BIO BONE FIXATION SCREW SYSTEMK063770ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM

Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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