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FDA 510(k)

BIO74-PF CROWN & BRIDGE ALLOY

K-Number: K943487 · 1994-08-10

ApplicantJeneric/Pentron, Inc.
Decision Date1994-08-10
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIO74-PF CROWN & BRIDGE ALLOY is the device name listed in this FDA 510(k) record. The listed applicant is Jeneric/Pentron, Inc.. It received FDA 510(k) clearance on 1994-08-10 under 510(k) number K943487. 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 BIO74-PF CROWN & BRIDGE ALLOY?

BIO74-PF CROWN & BRIDGE ALLOY is a medical device that received FDA 510(k) clearance on 1994-08-10. The listed applicant is Jeneric/Pentron, Inc.. The 510(k) number is K943487.

When did BIO74-PF CROWN & BRIDGE ALLOY receive FDA 510(k) clearance?

BIO74-PF CROWN & BRIDGE ALLOY received FDA 510(k) clearance on 1994-08-10, under 510(k) number K943487.

Who is the listed applicant for BIO74-PF CROWN & BRIDGE ALLOY?

The FDA 510(k) record lists Jeneric/Pentron, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO74-PF CROWN & BRIDGE ALLOY?

The FDA product code for BIO74-PF CROWN & BRIDGE ALLOY is EJT.

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Other records listing Jeneric/Pentron, Inc. as applicant

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K020499BOND-3 ADHESIVEK013543BOND-1 C & BK013542DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)K012231AVANTE MICRO CRYSTAL SYSTEMK011748FIRST FILL R.C.S.K010957QUELL DESENSITIZER

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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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