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FDA 510(k)

X-L AND X-LX

K-Number: K905325 · 1990-12-21

ApplicantIvoclar North America, Inc.
Decision Date1990-12-21
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

X-L AND X-LX 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 1990-12-21 under 510(k) number K905325. 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 X-L AND X-LX?

X-L AND X-LX is a medical device that received FDA 510(k) clearance on 1990-12-21. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K905325.

When did X-L AND X-LX receive FDA 510(k) clearance?

X-L AND X-LX received FDA 510(k) clearance on 1990-12-21, under 510(k) number K905325.

Who is the listed applicant for X-L AND X-LX?

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 X-L AND X-LX?

The FDA product code for X-L AND X-LX 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 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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