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FDA 510(k)

PONTOR 4 CF

K-Number: K911541 · 1991-04-29

ApplicantMetalor Dental USA Corp.
Decision Date1991-04-29
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PONTOR 4 CF 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 1991-04-29 under 510(k) number K911541. 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 PONTOR 4 CF?

PONTOR 4 CF is a medical device that received FDA 510(k) clearance on 1991-04-29. The listed applicant is Metalor Dental USA Corp.. The 510(k) number is K911541.

When did PONTOR 4 CF receive FDA 510(k) clearance?

PONTOR 4 CF received FDA 510(k) clearance on 1991-04-29, under 510(k) number K911541.

Who is the listed applicant for PONTOR 4 CF?

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 PONTOR 4 CF?

The FDA product code for PONTOR 4 CF 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. 5154K993507V-SUPRAGOLD, ALLOY NO. 5024K993508V-SUPRA PLUS, ALLOY NO. 5025

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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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