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FDA 510(k)

STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281

K-Number: K984340 · 1999-01-08

ApplicantSterngold/Implamed
Decision Date1999-01-08
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281 is the device name listed in this FDA 510(k) record. The listed applicant is Sterngold/Implamed. It received FDA 510(k) clearance on 1999-01-08 under 510(k) number K984340. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281?

STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281 is a medical device that received FDA 510(k) clearance on 1999-01-08. The listed applicant is Sterngold/Implamed. The 510(k) number is K984340.

When did STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281 receive FDA 510(k) clearance?

STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281 received FDA 510(k) clearance on 1999-01-08, under 510(k) number K984340.

Who is the listed applicant for STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281?

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 TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281?

The FDA product code for STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281 is EMA.

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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 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 SUBK962325QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015)

View all 16 devices →

Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, 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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