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FDA 510(k)

UCLA AND UNIVERSAL ABUTMENTS

K-Number: K010619 · 2001-09-28

ApplicantDiamodent
Decision Date2001-09-28
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UCLA AND UNIVERSAL ABUTMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Diamodent. It received FDA 510(k) clearance on 2001-09-28 under 510(k) number K010619. 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 UCLA AND UNIVERSAL ABUTMENTS?

UCLA AND UNIVERSAL ABUTMENTS is a medical device that received FDA 510(k) clearance on 2001-09-28. The listed applicant is Diamodent. The 510(k) number is K010619.

When did UCLA AND UNIVERSAL ABUTMENTS receive FDA 510(k) clearance?

UCLA AND UNIVERSAL ABUTMENTS received FDA 510(k) clearance on 2001-09-28, under 510(k) number K010619.

Who is the listed applicant for UCLA AND UNIVERSAL ABUTMENTS?

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

What is the FDA product code for UCLA AND UNIVERSAL ABUTMENTS?

The FDA product code for UCLA AND UNIVERSAL ABUTMENTS is DZE.

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Other records listing Diamodent 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.

K034022UCLA AND CEMENT-ON ABUTMENTS AND ACCESSORIESK993129UCLA/UNIVERSAL ABUTMENT

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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