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FDA 510(k)

V-GNATHOS PLUS

K-Number: K952122 · 1995-06-06

ApplicantMetalor Dental USA Corp.
Decision Date1995-06-06
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

V-GNATHOS PLUS 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 1995-06-06 under 510(k) number K952122. 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 V-GNATHOS PLUS?

V-GNATHOS PLUS is a medical device that received FDA 510(k) clearance on 1995-06-06. The listed applicant is Metalor Dental USA Corp.. The 510(k) number is K952122.

When did V-GNATHOS PLUS receive FDA 510(k) clearance?

V-GNATHOS PLUS received FDA 510(k) clearance on 1995-06-06, under 510(k) number K952122.

Who is the listed applicant for V-GNATHOS PLUS?

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 V-GNATHOS PLUS?

The FDA product code for V-GNATHOS PLUS 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. 5315K993505V-DELTA SPECIAL, ALLOY NO. 5154K993506PAGALINOR 4 , ALLOY NO. 5440K993508V-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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