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FDA 510(k)

STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC

K-Number: K982692 · 1998-10-22

ApplicantSterngold/Implamed
Decision Date1998-10-22
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC is the device name listed in this FDA 510(k) record. The listed applicant is Sterngold/Implamed. It received FDA 510(k) clearance on 1998-10-22 under 510(k) number K982692. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC?

STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC is a medical device that received FDA 510(k) clearance on 1998-10-22. The listed applicant is Sterngold/Implamed. The 510(k) number is K982692.

When did STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC receive FDA 510(k) clearance?

STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC received FDA 510(k) clearance on 1998-10-22, under 510(k) number K982692.

Who is the listed applicant for STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC?

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 STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC?

The FDA product code for STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC is EBF.

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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.

K984341STERNVANTAGE VARNISH LC, MODEL 221001K984340STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281K983786STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATIONK982895STERNOMEGA COMPOMER CEMENTK981516STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUBK962324STERNGOLD U-CPF METAL ALLOY (1067800)

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Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, 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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