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FDA 510(k)

OSTEOTAPE

K-Number: K090794 · 2009-12-10

ApplicantImpladent , Ltd.
Decision Date2009-12-10
Product CodeNPM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEOTAPE is the device name listed in this FDA 510(k) record. The listed applicant is Impladent , Ltd.. It received FDA 510(k) clearance on 2009-12-10 under 510(k) number K090794. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEOTAPE?

OSTEOTAPE is a medical device that received FDA 510(k) clearance on 2009-12-10. The listed applicant is Impladent , Ltd.. The 510(k) number is K090794.

When did OSTEOTAPE receive FDA 510(k) clearance?

OSTEOTAPE received FDA 510(k) clearance on 2009-12-10, under 510(k) number K090794.

Who is the listed applicant for OSTEOTAPE?

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

What is the FDA product code for OSTEOTAPE?

The FDA product code for OSTEOTAPE is NPM.

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 Impladent , Ltd. 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.

K033098OSTEOGEN SBRGK982925LAMINOSS DENTAL IMPLANTK933705LAMINOSS DENTAL IMPLANT

Related Devices (Code: NPM)

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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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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