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 IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION

K-Number: K983786 · 1998-11-13

ApplicantSterngold/Implamed
Decision Date1998-11-13
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION is the device name listed in this FDA 510(k) record. The listed applicant is Sterngold/Implamed. It received FDA 510(k) clearance on 1998-11-13 under 510(k) number K983786. 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 STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION?

STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION is a medical device that received FDA 510(k) clearance on 1998-11-13. The listed applicant is Sterngold/Implamed. The 510(k) number is K983786.

When did STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION receive FDA 510(k) clearance?

STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION received FDA 510(k) clearance on 1998-11-13, under 510(k) number K983786.

Who is the listed applicant for STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION?

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 IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION?

The FDA product code for STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION is DZE.

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 221001K982692STERNOMEGA 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 SUBK962325QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015)

View all 16 devices →

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.

↑