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FDA 510(k)

STERN ERA ALIGNMENT CORRECTION IMPLANT ABUTMENT

K-Number: K921010 · 1992-09-01

ApplicantApm Stern Gold
Decision Date1992-09-01
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STERN ERA ALIGNMENT CORRECTION IMPLANT ABUTMENT is the device name listed in this FDA 510(k) record. The listed applicant is Apm Stern Gold. It received FDA 510(k) clearance on 1992-09-01 under 510(k) number K921010. 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 STERN ERA ALIGNMENT CORRECTION IMPLANT ABUTMENT?

STERN ERA ALIGNMENT CORRECTION IMPLANT ABUTMENT is a medical device that received FDA 510(k) clearance on 1992-09-01. The listed applicant is Apm Stern Gold. The 510(k) number is K921010.

When did STERN ERA ALIGNMENT CORRECTION IMPLANT ABUTMENT receive FDA 510(k) clearance?

STERN ERA ALIGNMENT CORRECTION IMPLANT ABUTMENT received FDA 510(k) clearance on 1992-09-01, under 510(k) number K921010.

Who is the listed applicant for STERN ERA ALIGNMENT CORRECTION IMPLANT ABUTMENT?

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

What is the FDA product code for STERN ERA ALIGNMENT CORRECTION IMPLANT ABUTMENT?

The FDA product code for STERN ERA ALIGNMENT CORRECTION IMPLANT ABUTMENT is DZE.

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Related Devices (Code: DZE)

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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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