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FDA 510(k)

I-MINI DENTAL IMPLANT

K-Number: K080115 · 2008-05-30

ApplicantOco Biomedical
Decision Date2008-05-30
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

I-MINI DENTAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Oco Biomedical. It received FDA 510(k) clearance on 2008-05-30 under 510(k) number K080115. 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 I-MINI DENTAL IMPLANT?

I-MINI DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 2008-05-30. The listed applicant is Oco Biomedical. The 510(k) number is K080115.

When did I-MINI DENTAL IMPLANT receive FDA 510(k) clearance?

I-MINI DENTAL IMPLANT received FDA 510(k) clearance on 2008-05-30, under 510(k) number K080115.

Who is the listed applicant for I-MINI DENTAL IMPLANT?

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

What is the FDA product code for I-MINI DENTAL IMPLANT?

The FDA product code for I-MINI DENTAL IMPLANT is DZE.

Related Clinical Trials

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Other records listing Oco Biomedical 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.

K1221986.00MM X 6.00MM MACRO EXTERNAL IMPLANT SYSTEMK110337UNIVERSAL MAXILLARY MOLARK090174TSI; ERI

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

View on FDA Database →

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

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