FDA 510(k)

CAVI-ZYME

K-Number: K922633 · 1992-08-06

Decision Date1992-08-06

Product CodeEJB

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

CAVI-ZYME is the device name listed in this FDA 510(k) record. The listed applicant is E&D Dental Products, Inc.. It received FDA 510(k) clearance on 1992-08-06 under 510(k) number K922633. The device is classified under product code EJB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAVI-ZYME?

CAVI-ZYME is a medical device that received FDA 510(k) clearance on 1992-08-06. The listed applicant is E&D Dental Products, Inc.. The 510(k) number is K922633.

When did CAVI-ZYME receive FDA 510(k) clearance?

CAVI-ZYME received FDA 510(k) clearance on 1992-08-06, under 510(k) number K922633.

Who is the listed applicant for CAVI-ZYME?

The FDA 510(k) record lists E&D Dental Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAVI-ZYME?

The FDA product code for CAVI-ZYME is EJB.

Other records listing E&D Dental Products, 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.

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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.