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FDA 510(k)

OSI O-BALL ABUTMENT HEAD IMPLANTS

K-Number: K110548 · 2011-07-29

ApplicantJuell Dental
Decision Date2011-07-29
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSI O-BALL ABUTMENT HEAD IMPLANTS is the device name listed in this FDA 510(k) record. The listed applicant is Juell Dental. It received FDA 510(k) clearance on 2011-07-29 under 510(k) number K110548. 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 OSI O-BALL ABUTMENT HEAD IMPLANTS?

OSI O-BALL ABUTMENT HEAD IMPLANTS is a medical device that received FDA 510(k) clearance on 2011-07-29. The listed applicant is Juell Dental. The 510(k) number is K110548.

When did OSI O-BALL ABUTMENT HEAD IMPLANTS receive FDA 510(k) clearance?

OSI O-BALL ABUTMENT HEAD IMPLANTS received FDA 510(k) clearance on 2011-07-29, under 510(k) number K110548.

Who is the listed applicant for OSI O-BALL ABUTMENT HEAD IMPLANTS?

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

What is the FDA product code for OSI O-BALL ABUTMENT HEAD IMPLANTS?

The FDA product code for OSI O-BALL ABUTMENT HEAD IMPLANTS is DZE.

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Other records listing Juell Dental 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.

K111177JUELL HARD CUREK111178JUELL SOFT CURE

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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