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FDA 510(k)

REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE

K-Number: K023952 · 2003-01-16

ApplicantNobel Biocare Uas, Inc.
Decision Date2003-01-16
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE 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 2003-01-16 under 510(k) number K023952. 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 ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE?

REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE is a medical device that received FDA 510(k) clearance on 2003-01-16. The listed applicant is Nobel Biocare Uas, Inc.. The 510(k) number is K023952.

When did REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE receive FDA 510(k) clearance?

REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE received FDA 510(k) clearance on 2003-01-16, under 510(k) number K023952.

Who is the listed applicant for REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE?

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 ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE?

The FDA product code for REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE is DZE.

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Other records listing Nobel Biocare Uas, Inc. as applicant

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K050444NOBELREPLACE ADAPTER, MODEL 32412K042658PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004K041661NOBEL BIOCARE ENDOSSEOUS IMPLANTSK041876NOBELDIRECT OD IMPLANTK041312NOBELRONDO DENTAL CERAMIC-ALUMINAK041275PROCERA ABUTMENT OCTAGON

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Related Devices (Code: 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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