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FDA 510(k)

REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162

K-Number: K022424 · 2002-09-27

ApplicantNobel Biocare Uas, Inc.
Decision Date2002-09-27
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162 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 2002-09-27 under 510(k) number K022424. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162?

REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162 is a medical device that received FDA 510(k) clearance on 2002-09-27. The listed applicant is Nobel Biocare Uas, Inc.. The 510(k) number is K022424.

When did REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162 receive FDA 510(k) clearance?

REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162 received FDA 510(k) clearance on 2002-09-27, under 510(k) number K022424.

Who is the listed applicant for REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162?

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 REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162?

The FDA product code for REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162 is DZE.

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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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