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FDA 510(k)

RD-3008

K-Number: K011036 · 2001-05-10

ApplicantHeraeus Kulzer, Inc.
Decision Date2001-05-10
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RD-3008 is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 2001-05-10 under 510(k) number K011036. 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 RD-3008?

RD-3008 is a medical device that received FDA 510(k) clearance on 2001-05-10. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K011036.

When did RD-3008 receive FDA 510(k) clearance?

RD-3008 received FDA 510(k) clearance on 2001-05-10, under 510(k) number K011036.

Who is the listed applicant for RD-3008?

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

What is the FDA product code for RD-3008?

The FDA product code for RD-3008 is EJT.

Other records listing Heraeus Kulzer, 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.

K091494FLEXITIME FLOWK063062HKBOND 2006K060994MONDIALK052543HERACERAM ZIRKONIAK043504PALAIMPACTK043295VERSYO.DIRECT

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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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