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FDA 510(k)

D.SIGN 96

K-Number: K011023 · 2001-05-02

ApplicantIvoclar North America, Inc.
Decision Date2001-05-02
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

D.SIGN 96 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 2001-05-02 under 510(k) number K011023. 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 D.SIGN 96?

D.SIGN 96 is a medical device that received FDA 510(k) clearance on 2001-05-02. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K011023.

When did D.SIGN 96 receive FDA 510(k) clearance?

D.SIGN 96 received FDA 510(k) clearance on 2001-05-02, under 510(k) number K011023.

Who is the listed applicant for D.SIGN 96?

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 D.SIGN 96?

The FDA product code for D.SIGN 96 is EJT.

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 EXCITEK011022BIOUNIVERSAL PDFK010381D.SIGN 30

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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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