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FDA 510(k)

ABSOANCHOR MICROIMPLANT

K-Number: K060126 · 2006-05-16

ApplicantDentos, Inc.
Decision Date2006-05-16
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ABSOANCHOR MICROIMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Dentos, Inc.. It received FDA 510(k) clearance on 2006-05-16 under 510(k) number K060126. 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 ABSOANCHOR MICROIMPLANT?

ABSOANCHOR MICROIMPLANT is a medical device that received FDA 510(k) clearance on 2006-05-16. The listed applicant is Dentos, Inc.. The 510(k) number is K060126.

When did ABSOANCHOR MICROIMPLANT receive FDA 510(k) clearance?

ABSOANCHOR MICROIMPLANT received FDA 510(k) clearance on 2006-05-16, under 510(k) number K060126.

Who is the listed applicant for ABSOANCHOR MICROIMPLANT?

The FDA 510(k) record lists Dentos, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABSOANCHOR MICROIMPLANT?

The FDA product code for ABSOANCHOR MICROIMPLANT 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 Dentos, Inc. 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.

K181142Absoanchor Microimplant

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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