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FDA 510(k)

HARMONY LINE KF

K-Number: K951297 · 1995-04-18

ApplicantIvoclar North America, Inc.
Decision Date1995-04-18
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HARMONY LINE KF is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar North America, Inc.. It received FDA 510(k) clearance on 1995-04-18 under 510(k) number K951297. 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 HARMONY LINE KF?

HARMONY LINE KF is a medical device that received FDA 510(k) clearance on 1995-04-18. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K951297.

When did HARMONY LINE KF receive FDA 510(k) clearance?

HARMONY LINE KF received FDA 510(k) clearance on 1995-04-18, under 510(k) number K951297.

Who is the listed applicant for HARMONY LINE KF?

The FDA 510(k) record lists Ivoclar North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HARMONY LINE KF?

The FDA product code for HARMONY LINE KF is EJT.

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Other records listing Ivoclar North America, Inc. 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.

K012174ERIS LAYERING MATERIALSK011491HELIOSEAL CLEAR CHROMAK011492IN TEN-SK011490MODIFICATION TO EXCITEK011023D.SIGN 96K011022BIOUNIVERSAL PDF

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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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