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FDA 510(k)

ERA IMPLANT

K-Number: K021045 · 2002-06-26

ApplicantSterngold
Decision Date2002-06-26
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ERA IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Sterngold. It received FDA 510(k) clearance on 2002-06-26 under 510(k) number K021045. 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 ERA IMPLANT?

ERA IMPLANT is a medical device that received FDA 510(k) clearance on 2002-06-26. The listed applicant is Sterngold. The 510(k) number is K021045.

When did ERA IMPLANT receive FDA 510(k) clearance?

ERA IMPLANT received FDA 510(k) clearance on 2002-06-26, under 510(k) number K021045.

Who is the listed applicant for ERA IMPLANT?

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

What is the FDA product code for ERA IMPLANT?

The FDA product code for ERA IMPLANT is DZE.

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Other records listing Sterngold 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.

K092434STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEMK041271STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEMK023580STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEMK022252STERNGOLD 1, MODEL 1127781K021741CRITERTION, MODEL #1067511K021367STERNGOLD 66, MODEL #1180230

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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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