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FDA 510(k)

MODIFICATION TO: CRESCO TI IMPLANT CONCEPT

K-Number: K042354 · 2004-09-21

ApplicantCresco TI Systems AB
Decision Date2004-09-21
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: CRESCO TI IMPLANT CONCEPT is the device name listed in this FDA 510(k) record. The listed applicant is Cresco TI Systems AB. It received FDA 510(k) clearance on 2004-09-21 under 510(k) number K042354. 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 MODIFICATION TO: CRESCO TI IMPLANT CONCEPT?

MODIFICATION TO: CRESCO TI IMPLANT CONCEPT is a medical device that received FDA 510(k) clearance on 2004-09-21. The listed applicant is Cresco TI Systems AB. The 510(k) number is K042354.

When did MODIFICATION TO: CRESCO TI IMPLANT CONCEPT receive FDA 510(k) clearance?

MODIFICATION TO: CRESCO TI IMPLANT CONCEPT received FDA 510(k) clearance on 2004-09-21, under 510(k) number K042354.

Who is the listed applicant for MODIFICATION TO: CRESCO TI IMPLANT CONCEPT?

The FDA 510(k) record lists Cresco TI Systems AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO: CRESCO TI IMPLANT CONCEPT?

The FDA product code for MODIFICATION TO: CRESCO TI IMPLANT CONCEPT is DZE.

Related Clinical Trials

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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Other records listing Cresco TI Systems AB 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.

K981052CRESCO TI IMPLANT CONCEPT

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

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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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