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FDA 510(k)

ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114

K-Number: K072660 · 2007-12-12

ApplicantImtec Corp.
Decision Date2007-12-12
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 is the device name listed in this FDA 510(k) record. The listed applicant is Imtec Corp.. It received FDA 510(k) clearance on 2007-12-12 under 510(k) number K072660. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114?

ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 is a medical device that received FDA 510(k) clearance on 2007-12-12. The listed applicant is Imtec Corp.. The 510(k) number is K072660.

When did ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 receive FDA 510(k) clearance?

ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 received FDA 510(k) clearance on 2007-12-12, under 510(k) number K072660.

Who is the listed applicant for ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114?

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

What is the FDA product code for ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114?

The FDA product code for ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 is DZE.

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Other records listing Imtec 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.

K081653MDI MII ONE-PIECE IMPLANT, 2.9MMK081347ILUMA VISIONK053046ILUMA ORTHOCAT/DENTALCATK043226ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320K042289MDI ORTHOK033432LEXATITE QUICK ACRYLIC

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Related Devices (Code: DZE)

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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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