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)

WHITE SILVER SOLDER AND YELLOW SILVER SOLDER

K-Number: K860964 · 1986-03-26

ApplicantAustenal Dental, Inc.
Decision Date1986-03-26
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

WHITE SILVER SOLDER AND YELLOW SILVER SOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Austenal Dental, Inc.. It received FDA 510(k) clearance on 1986-03-26 under 510(k) number K860964. 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 WHITE SILVER SOLDER AND YELLOW SILVER SOLDER?

WHITE SILVER SOLDER AND YELLOW SILVER SOLDER is a medical device that received FDA 510(k) clearance on 1986-03-26. The listed applicant is Austenal Dental, Inc.. The 510(k) number is K860964.

When did WHITE SILVER SOLDER AND YELLOW SILVER SOLDER receive FDA 510(k) clearance?

WHITE SILVER SOLDER AND YELLOW SILVER SOLDER received FDA 510(k) clearance on 1986-03-26, under 510(k) number K860964.

Who is the listed applicant for WHITE SILVER SOLDER AND YELLOW SILVER SOLDER?

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

What is the FDA product code for WHITE SILVER SOLDER AND YELLOW SILVER SOLDER?

The FDA product code for WHITE SILVER SOLDER AND YELLOW SILVER SOLDER 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 Austenal Dental, Inc. 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.

K890713OVERDENTURE - STUD ATTACHMENTK883799BASE, DENTURE, RELINING, REPAIRING, REBASING,RESINK880875VITALLIUM EQUIPOISE ALLOYK871849LIGHT CURE DENTURE GLAZEK872746VITALLIUM WIREK863630AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL

View all 19 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.

↑