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FDA 510(k)

BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS

K-Number: K101608 · 2011-03-11

ApplicantBiomet 3i, Inc.
Decision Date2011-03-11
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS 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 2011-03-11 under 510(k) number K101608. 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 BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS?

BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS is a medical device that received FDA 510(k) clearance on 2011-03-11. The listed applicant is Biomet 3i, Inc.. The 510(k) number is K101608.

When did BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS receive FDA 510(k) clearance?

BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS received FDA 510(k) clearance on 2011-03-11, under 510(k) number K101608.

Who is the listed applicant for BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS?

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 BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS?

The FDA product code for BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS is NHA.

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Other records listing Biomet 3i, Inc. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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