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FDA 510(k)

TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK

K-Number: K091392 · 2009-07-30

ApplicantPou YU Biotechnology Co., Ltd.
Decision Date2009-07-30
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK is the device name listed in this FDA 510(k) record. The listed applicant is Pou YU Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2009-07-30 under 510(k) number K091392. 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 TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK?

TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK is a medical device that received FDA 510(k) clearance on 2009-07-30. The listed applicant is Pou YU Biotechnology Co., Ltd.. The 510(k) number is K091392.

When did TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK receive FDA 510(k) clearance?

TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK received FDA 510(k) clearance on 2009-07-30, under 510(k) number K091392.

Who is the listed applicant for TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK?

The FDA 510(k) record lists Pou YU Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK?

The FDA product code for TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK is NHA.

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Other records listing Pou YU Biotechnology Co., Ltd. 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.

K103339TDS ABUTMENT FOR FRIADENT XIVEK100356TDS PRECISION DENTAL BARK091693TDS ZIRCONIA ABUTMENT FOR NOBEL BIOCARE BRANEMARKK091026TDS ABUTMENT FOR NOBEL BIOCARE REPLACEK081460TDS ABUTMENT

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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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