FDA 510(k)

ENDO-CORE

K-Number: K912720 · 1991-08-20

Decision Date1991-08-20

Product CodeELR

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ENDO-CORE is the device name listed in this FDA 510(k) record. The listed applicant is Metalor Dental USA Corp.. It received FDA 510(k) clearance on 1991-08-20 under 510(k) number K912720. 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 ENDO-CORE?

ENDO-CORE is a medical device that received FDA 510(k) clearance on 1991-08-20. The listed applicant is Metalor Dental USA Corp.. The 510(k) number is K912720.

When did ENDO-CORE receive FDA 510(k) clearance?

ENDO-CORE received FDA 510(k) clearance on 1991-08-20, under 510(k) number K912720.

Who is the listed applicant for ENDO-CORE?

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

What is the FDA product code for ENDO-CORE?

The FDA product code for ENDO-CORE is ELR.

Other records listing Metalor Dental USA 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.

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Related Devices (Code: ELR)

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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.