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FDA 510(k)

CAPA PRE-FORMED PORCELAIN CROWN

K-Number: K852145 · 1985-07-02

ApplicantCapa Industries
Decision Date1985-07-02
Product CodeELL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CAPA PRE-FORMED PORCELAIN CROWN is the device name listed in this FDA 510(k) record. The listed applicant is Capa Industries. It received FDA 510(k) clearance on 1985-07-02 under 510(k) number K852145. The device is classified under product code ELL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPA PRE-FORMED PORCELAIN CROWN?

CAPA PRE-FORMED PORCELAIN CROWN is a medical device that received FDA 510(k) clearance on 1985-07-02. The listed applicant is Capa Industries. The 510(k) number is K852145.

When did CAPA PRE-FORMED PORCELAIN CROWN receive FDA 510(k) clearance?

CAPA PRE-FORMED PORCELAIN CROWN received FDA 510(k) clearance on 1985-07-02, under 510(k) number K852145.

Who is the listed applicant for CAPA PRE-FORMED PORCELAIN CROWN?

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

What is the FDA product code for CAPA PRE-FORMED PORCELAIN CROWN?

The FDA product code for CAPA PRE-FORMED PORCELAIN CROWN is ELL.

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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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