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FDA 510(k)

COSMOPOST

K-Number: K972875 · 1997-09-17

ApplicantIvoclar North America, Inc.
Decision Date1997-09-17
Product CodeELR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COSMOPOST 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 1997-09-17 under 510(k) number K972875. The device is classified under product code ELR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COSMOPOST?

COSMOPOST is a medical device that received FDA 510(k) clearance on 1997-09-17. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K972875.

When did COSMOPOST receive FDA 510(k) clearance?

COSMOPOST received FDA 510(k) clearance on 1997-09-17, under 510(k) number K972875.

Who is the listed applicant for COSMOPOST?

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 COSMOPOST?

The FDA product code for COSMOPOST is ELR.

Related Clinical Trials

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.

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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

View all 131 devices →

Related Devices (Code: ELR)

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.

K060075FIBER-METAL POSTForemost Dental, LLCK042848FRC POSTEC PLUSIvoclar Vivadent, Inc.K030820EVERSTICK POSTStick Tech , Ltd.K020431FIBIOCOREEst. AnthogyrK012496CARBON POSTJ. Morita USA, Inc.K013802FRC POSTECIvoclar Vivadent, Inc.

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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