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FDA 510(k)

DW 276 #3

K-Number: K003635 · 2000-12-22

ApplicantIvoclar North America, Inc.
Decision Date2000-12-22
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DW 276 #3 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 2000-12-22 under 510(k) number K003635. 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 DW 276 #3?

DW 276 #3 is a medical device that received FDA 510(k) clearance on 2000-12-22. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K003635.

When did DW 276 #3 receive FDA 510(k) clearance?

DW 276 #3 received FDA 510(k) clearance on 2000-12-22, under 510(k) number K003635.

Who is the listed applicant for DW 276 #3?

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 DW 276 #3?

The FDA product code for DW 276 #3 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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