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FDA 510(k)

PROCERA BRIDGE ZIRCONIA

K-Number: K041283 · 2004-05-28

ApplicantNobel Biocare AB
Decision Date2004-05-28
Product CodeELL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROCERA BRIDGE ZIRCONIA 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 2004-05-28 under 510(k) number K041283. The device is classified under product code ELL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROCERA BRIDGE ZIRCONIA?

PROCERA BRIDGE ZIRCONIA is a medical device that received FDA 510(k) clearance on 2004-05-28. The listed applicant is Nobel Biocare AB. The 510(k) number is K041283.

When did PROCERA BRIDGE ZIRCONIA receive FDA 510(k) clearance?

PROCERA BRIDGE ZIRCONIA received FDA 510(k) clearance on 2004-05-28, under 510(k) number K041283.

Who is the listed applicant for PROCERA BRIDGE ZIRCONIA?

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 PROCERA BRIDGE ZIRCONIA?

The FDA product code for PROCERA BRIDGE ZIRCONIA is ELL.

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Other records listing Nobel Biocare AB as applicant

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Related Devices (Code: ELL)

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.

K240586Additive Manufacturing Zirconia Customized RestorationHangzhou Thales Medtech Co., Ltd.K203072Franz Zirconia Dental CrownFranz Biotech, Inc.K162043NobelProcera HT ML FCZ BridgeNobel Biocare ABK153534NobelProcera HT ML Full Contour Zirconia CrownNobel Biocare ABK071182PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013Nobel Biocare ABK060530SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.Lifecore Biomedical, 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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