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FDA 510(k)

ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320

K-Number: K043226 · 2005-01-13

ApplicantImtec Corp.
Decision Date2005-01-13
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320 is the device name listed in this FDA 510(k) record. The listed applicant is Imtec Corp.. It received FDA 510(k) clearance on 2005-01-13 under 510(k) number K043226. 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, MODELS 3508, 4308, 3520, 4320?

ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320 is a medical device that received FDA 510(k) clearance on 2005-01-13. The listed applicant is Imtec Corp.. The 510(k) number is K043226.

When did ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320 receive FDA 510(k) clearance?

ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320 received FDA 510(k) clearance on 2005-01-13, under 510(k) number K043226.

Who is the listed applicant for ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320?

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, MODELS 3508, 4308, 3520, 4320?

The FDA product code for ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320 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 VISIONK072660ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114K053046ILUMA ORTHOCAT/DENTALCATK042289MDI 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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