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FDA 510(k)

SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.

K-Number: K060530 · 2006-05-22

ApplicantLifecore Biomedical, Inc.
Decision Date2006-05-22
Product CodeELL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302. is the device name listed in this FDA 510(k) record. The listed applicant is Lifecore Biomedical, Inc.. It received FDA 510(k) clearance on 2006-05-22 under 510(k) number K060530. 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 SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.?

SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302. is a medical device that received FDA 510(k) clearance on 2006-05-22. The listed applicant is Lifecore Biomedical, Inc.. The 510(k) number is K060530.

When did SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302. receive FDA 510(k) clearance?

SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302. received FDA 510(k) clearance on 2006-05-22, under 510(k) number K060530.

Who is the listed applicant for SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.?

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

What is the FDA product code for SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.?

The FDA product code for SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302. is ELL.

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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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