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FDA 510(k)

AUROFLUID CPF

K-Number: K982606 · 1998-10-15

ApplicantMetalor Dental USA Corp.
Decision Date1998-10-15
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AUROFLUID CPF is the device name listed in this FDA 510(k) record. The listed applicant is Metalor Dental USA Corp.. It received FDA 510(k) clearance on 1998-10-15 under 510(k) number K982606. 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 AUROFLUID CPF?

AUROFLUID CPF is a medical device that received FDA 510(k) clearance on 1998-10-15. The listed applicant is Metalor Dental USA Corp.. The 510(k) number is K982606.

When did AUROFLUID CPF receive FDA 510(k) clearance?

AUROFLUID CPF received FDA 510(k) clearance on 1998-10-15, under 510(k) number K982606.

Who is the listed applicant for AUROFLUID CPF?

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

What is the FDA product code for AUROFLUID CPF?

The FDA product code for AUROFLUID CPF is EJT.

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Other records listing Metalor Dental USA Corp. 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.

K003387AUROFILM NPK993475AUROFLUID M, ALLOY NO. 5315K993506PAGALINOR 4 , ALLOY NO. 5440K993505V-DELTA SPECIAL, ALLOY NO. 5154K993508V-SUPRA PLUS, ALLOY NO. 5025K993507V-SUPRAGOLD, ALLOY NO. 5024

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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

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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