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FDA 510(k)

ENCODE PATIENT SPECIFIC ABUTMENT

K-Number: K102209 · 2010-12-03

ApplicantBiomet 3i, Inc.
Decision Date2010-12-03
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENCODE PATIENT SPECIFIC ABUTMENT is the device name listed in this FDA 510(k) record. The listed applicant is Biomet 3i, Inc.. It received FDA 510(k) clearance on 2010-12-03 under 510(k) number K102209. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENCODE PATIENT SPECIFIC ABUTMENT?

ENCODE PATIENT SPECIFIC ABUTMENT is a medical device that received FDA 510(k) clearance on 2010-12-03. The listed applicant is Biomet 3i, Inc.. The 510(k) number is K102209.

When did ENCODE PATIENT SPECIFIC ABUTMENT receive FDA 510(k) clearance?

ENCODE PATIENT SPECIFIC ABUTMENT received FDA 510(k) clearance on 2010-12-03, under 510(k) number K102209.

Who is the listed applicant for ENCODE PATIENT SPECIFIC ABUTMENT?

The FDA 510(k) record lists Biomet 3i, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENCODE PATIENT SPECIFIC ABUTMENT?

The FDA product code for ENCODE PATIENT SPECIFIC ABUTMENT is NHA.

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Other records listing Biomet 3i, Inc. as applicant

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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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