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FDA 510(k)

ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT

K-Number: K130408 · 2013-07-01

ApplicantSterngold Dental, LLC
Decision Date2013-07-01
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT is the device name listed in this FDA 510(k) record. The listed applicant is Sterngold Dental, LLC. It received FDA 510(k) clearance on 2013-07-01 under 510(k) number K130408. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT?

ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT is a medical device that received FDA 510(k) clearance on 2013-07-01. The listed applicant is Sterngold Dental, LLC. The 510(k) number is K130408.

When did ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT receive FDA 510(k) clearance?

ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT received FDA 510(k) clearance on 2013-07-01, under 510(k) number K130408.

Who is the listed applicant for ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT?

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

What is the FDA product code for ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT?

The FDA product code for ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT is NHA.

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Other records listing Sterngold Dental, LLC as applicant

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K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmK153173MOR Implant SystemK130183SFI BAR ABUTMENTSK111798STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM ...

Related Devices (Code: NHA)

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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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