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FDA 510(k)

TEETH IN AN HOUR - ARK IMPLANT CONCEPT

K-Number: K030685 · 2004-02-06

ApplicantNobel Biocare AB
Decision Date2004-02-06
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TEETH IN AN HOUR - ARK IMPLANT CONCEPT is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare AB. It received FDA 510(k) clearance on 2004-02-06 under 510(k) number K030685. 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 TEETH IN AN HOUR - ARK IMPLANT CONCEPT?

TEETH IN AN HOUR - ARK IMPLANT CONCEPT is a medical device that received FDA 510(k) clearance on 2004-02-06. The listed applicant is Nobel Biocare AB. The 510(k) number is K030685.

When did TEETH IN AN HOUR - ARK IMPLANT CONCEPT receive FDA 510(k) clearance?

TEETH IN AN HOUR - ARK IMPLANT CONCEPT received FDA 510(k) clearance on 2004-02-06, under 510(k) number K030685.

Who is the listed applicant for TEETH IN AN HOUR - ARK IMPLANT CONCEPT?

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

What is the FDA product code for TEETH IN AN HOUR - ARK IMPLANT CONCEPT?

The FDA product code for TEETH IN AN HOUR - ARK IMPLANT CONCEPT is DZE.

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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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