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FDA 510(k)

DEGUBOND ULTRA

K-Number: K953344 · 1995-08-25

ApplicantDegussa AG
Decision Date1995-08-25
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DEGUBOND ULTRA is the device name listed in this FDA 510(k) record. The listed applicant is Degussa AG. It received FDA 510(k) clearance on 1995-08-25 under 510(k) number K953344. 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 DEGUBOND ULTRA?

DEGUBOND ULTRA is a medical device that received FDA 510(k) clearance on 1995-08-25. The listed applicant is Degussa AG. The 510(k) number is K953344.

When did DEGUBOND ULTRA receive FDA 510(k) clearance?

DEGUBOND ULTRA received FDA 510(k) clearance on 1995-08-25, under 510(k) number K953344.

Who is the listed applicant for DEGUBOND ULTRA?

The FDA 510(k) record lists Degussa AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEGUBOND ULTRA?

The FDA product code for DEGUBOND ULTRA is EJT.

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Other records listing Degussa AG 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.

K931808DUCERAGOLD, DUCERATINK926347DUCERANIUM UK922790DEGUCAST 40K921772BIOLORK921479DUCERATIN/DUCERAM LFC DENTAL PORCELAINK921419DEVA PLUS

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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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