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FDA 510(k)

REPLACE SCALLOPED MARGIN IMPLANT SYSTEM

K-Number: K021584 · 2002-06-05

ApplicantNobel Biocare Uas, Inc.
Decision Date2002-06-05
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REPLACE SCALLOPED MARGIN IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare Uas, Inc.. It received FDA 510(k) clearance on 2002-06-05 under 510(k) number K021584. 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 REPLACE SCALLOPED MARGIN IMPLANT SYSTEM?

REPLACE SCALLOPED MARGIN IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2002-06-05. The listed applicant is Nobel Biocare Uas, Inc.. The 510(k) number is K021584.

When did REPLACE SCALLOPED MARGIN IMPLANT SYSTEM receive FDA 510(k) clearance?

REPLACE SCALLOPED MARGIN IMPLANT SYSTEM received FDA 510(k) clearance on 2002-06-05, under 510(k) number K021584.

Who is the listed applicant for REPLACE SCALLOPED MARGIN IMPLANT SYSTEM?

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

What is the FDA product code for REPLACE SCALLOPED MARGIN IMPLANT SYSTEM?

The FDA product code for REPLACE SCALLOPED MARGIN IMPLANT SYSTEM is DZE.

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Other records listing Nobel Biocare Uas, Inc. 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.

K050444NOBELREPLACE ADAPTER, MODEL 32412K042658PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004K041661NOBEL BIOCARE ENDOSSEOUS IMPLANTSK041876NOBELDIRECT OD IMPLANTK041312NOBELRONDO DENTAL CERAMIC-ALUMINAK041275PROCERA ABUTMENT OCTAGON

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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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