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FDA 510(k)

THE STERN ERA SYSTEM

K-Number: K913348 · 1992-01-30

ApplicantSterngold/Implamed
Decision Date1992-01-30
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THE STERN ERA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sterngold/Implamed. It received FDA 510(k) clearance on 1992-01-30 under 510(k) number K913348. 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 THE STERN ERA SYSTEM?

THE STERN ERA SYSTEM is a medical device that received FDA 510(k) clearance on 1992-01-30. The listed applicant is Sterngold/Implamed. The 510(k) number is K913348.

When did THE STERN ERA SYSTEM receive FDA 510(k) clearance?

THE STERN ERA SYSTEM received FDA 510(k) clearance on 1992-01-30, under 510(k) number K913348.

Who is the listed applicant for THE STERN ERA SYSTEM?

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

What is the FDA product code for THE STERN ERA SYSTEM?

The FDA product code for THE STERN ERA SYSTEM is DZE.

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Other records listing Sterngold/Implamed 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.

K984340STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281K984341STERNVANTAGE VARNISH LC, MODEL 221001K983786STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATIONK982692STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LCK982895STERNOMEGA COMPOMER CEMENTK981516STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB

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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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