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FDA 510(k)

BUTLER GUM PROPHY PASTE WITH NOVAMIN

K-Number: K024343 · 2003-07-11

ApplicantUsbiomaterials Corp.
Decision Date2003-07-11
Product CodeEJR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BUTLER GUM PROPHY PASTE WITH NOVAMIN is the device name listed in this FDA 510(k) record. The listed applicant is Usbiomaterials Corp.. It received FDA 510(k) clearance on 2003-07-11 under 510(k) number K024343. The device is classified under product code EJR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUTLER GUM PROPHY PASTE WITH NOVAMIN?

BUTLER GUM PROPHY PASTE WITH NOVAMIN is a medical device that received FDA 510(k) clearance on 2003-07-11. The listed applicant is Usbiomaterials Corp.. The 510(k) number is K024343.

When did BUTLER GUM PROPHY PASTE WITH NOVAMIN receive FDA 510(k) clearance?

BUTLER GUM PROPHY PASTE WITH NOVAMIN received FDA 510(k) clearance on 2003-07-11, under 510(k) number K024343.

Who is the listed applicant for BUTLER GUM PROPHY PASTE WITH NOVAMIN?

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

What is the FDA product code for BUTLER GUM PROPHY PASTE WITH NOVAMIN?

The FDA product code for BUTLER GUM PROPHY PASTE WITH NOVAMIN is EJR.

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Other records listing Usbiomaterials Corp. 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.

K000149NOVABONE-BIOGLASS BONE GRAFT PARTICULATEK992416PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATEK962494PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATEK930115PERIOGLASS

Related Devices (Code: EJR)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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