Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

STERNGOLD BIO-4

K-Number: K962304 · 1996-07-23

ApplicantSterngold/Implamed
Decision Date1996-07-23
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STERNGOLD BIO-4 is the device name listed in this FDA 510(k) record. The listed applicant is Sterngold/Implamed. It received FDA 510(k) clearance on 1996-07-23 under 510(k) number K962304. The device is classified under product code EJS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERNGOLD BIO-4?

STERNGOLD BIO-4 is a medical device that received FDA 510(k) clearance on 1996-07-23. The listed applicant is Sterngold/Implamed. The 510(k) number is K962304.

When did STERNGOLD BIO-4 receive FDA 510(k) clearance?

STERNGOLD BIO-4 received FDA 510(k) clearance on 1996-07-23, under 510(k) number K962304.

Who is the listed applicant for STERNGOLD BIO-4?

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 STERNGOLD BIO-4?

The FDA product code for STERNGOLD BIO-4 is EJS.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 16 devices →

Related Devices (Code: EJS)

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.

K041433BRIGHT GOLD XHIvoclar Vivadent, Inc.K040436SIMIDUR SUPERIORWieland Dental + Technik GmbH & Co. KGK022252STERNGOLD 1, MODEL 1127781SterngoldK022469ECO E4Wieland Dental + Technik GmbH & Co. KGK021367STERNGOLD 66, MODEL #1180230SterngoldK020195SIMIDUR S1SWieland Dental + Technik GmbH & Co. KG

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.

↑