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FDA 510(k)

NOBELRONDO DENTAL CERAMIC-ALUMINA

K-Number: K041312 · 2004-07-23

ApplicantNobel Biocare Uas, Inc.
Decision Date2004-07-23
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NOBELRONDO DENTAL CERAMIC-ALUMINA 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 2004-07-23 under 510(k) number K041312. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOBELRONDO DENTAL CERAMIC-ALUMINA?

NOBELRONDO DENTAL CERAMIC-ALUMINA is a medical device that received FDA 510(k) clearance on 2004-07-23. The listed applicant is Nobel Biocare Uas, Inc.. The 510(k) number is K041312.

When did NOBELRONDO DENTAL CERAMIC-ALUMINA receive FDA 510(k) clearance?

NOBELRONDO DENTAL CERAMIC-ALUMINA received FDA 510(k) clearance on 2004-07-23, under 510(k) number K041312.

Who is the listed applicant for NOBELRONDO DENTAL CERAMIC-ALUMINA?

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 NOBELRONDO DENTAL CERAMIC-ALUMINA?

The FDA product code for NOBELRONDO DENTAL CERAMIC-ALUMINA is EIH.

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Other records listing Nobel Biocare Uas, Inc. as applicant

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K050444NOBELREPLACE ADAPTER, MODEL 32412K042658PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004K041661NOBEL BIOCARE ENDOSSEOUS IMPLANTSK041876NOBELDIRECT OD IMPLANTK041275PROCERA ABUTMENT OCTAGONK040573NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 31236

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Related Devices (Code: EIH)

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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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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