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FDA 510(k)

REPLACE TPS COATED IMPLANTS

K-Number: K002475 · 2000-11-09

ApplicantNobel Biocare Uas, Inc.
Decision Date2000-11-09
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REPLACE TPS COATED IMPLANTS 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 2000-11-09 under 510(k) number K002475. 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 TPS COATED IMPLANTS?

REPLACE TPS COATED IMPLANTS is a medical device that received FDA 510(k) clearance on 2000-11-09. The listed applicant is Nobel Biocare Uas, Inc.. The 510(k) number is K002475.

When did REPLACE TPS COATED IMPLANTS receive FDA 510(k) clearance?

REPLACE TPS COATED IMPLANTS received FDA 510(k) clearance on 2000-11-09, under 510(k) number K002475.

Who is the listed applicant for REPLACE TPS COATED IMPLANTS?

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 TPS COATED IMPLANTS?

The FDA product code for REPLACE TPS COATED IMPLANTS is DZE.

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Other records listing Nobel Biocare Uas, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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