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FDA 510(k)

MDI ORTHO

K-Number: K042289 · 2004-09-15

ApplicantImtec Corp.
Decision Date2004-09-15
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MDI ORTHO is the device name listed in this FDA 510(k) record. The listed applicant is Imtec Corp.. It received FDA 510(k) clearance on 2004-09-15 under 510(k) number K042289. 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 MDI ORTHO?

MDI ORTHO is a medical device that received FDA 510(k) clearance on 2004-09-15. The listed applicant is Imtec Corp.. The 510(k) number is K042289.

When did MDI ORTHO receive FDA 510(k) clearance?

MDI ORTHO received FDA 510(k) clearance on 2004-09-15, under 510(k) number K042289.

Who is the listed applicant for MDI ORTHO?

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 MDI ORTHO?

The FDA product code for MDI ORTHO 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/DENTALCATK043226ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320K033432LEXATITE QUICK ACRYLIC

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Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

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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