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FDA 510(k)

PROGOLD ELECTROCOPING SYSTEM

K-Number: K980613 · 1998-03-09

ApplicantMicro Dental Laboratories
Decision Date1998-03-09
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROGOLD ELECTROCOPING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Micro Dental Laboratories. It received FDA 510(k) clearance on 1998-03-09 under 510(k) number K980613. The device is classified under product code EJT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROGOLD ELECTROCOPING SYSTEM?

PROGOLD ELECTROCOPING SYSTEM is a medical device that received FDA 510(k) clearance on 1998-03-09. The listed applicant is Micro Dental Laboratories. The 510(k) number is K980613.

When did PROGOLD ELECTROCOPING SYSTEM receive FDA 510(k) clearance?

PROGOLD ELECTROCOPING SYSTEM received FDA 510(k) clearance on 1998-03-09, under 510(k) number K980613.

Who is the listed applicant for PROGOLD ELECTROCOPING SYSTEM?

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

What is the FDA product code for PROGOLD ELECTROCOPING SYSTEM?

The FDA product code for PROGOLD ELECTROCOPING SYSTEM is EJT.

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.

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Other records listing Micro Dental Laboratories 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.

K984467FUSICRYLK974622DENTAL D

Related Devices (Code: EJT)

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.

K052463PROMETAL HN86Prometal TechnologiesK041378BIO 60Kodent, Inc.K040672PORTA REFLEXWieland Dental + Technik GmbH & Co. KGK040524PORTA SOLDER 1090 WWieland Dental + Technik GmbH & Co. KGK040043NDX-40 ALLOYHeraeus Kulzer, Inc.K034049HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORMHeraeus Kulzer,GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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