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FDA 510(k)

s-Clean TiN Coating Abutments

K-Number: K171694 · 2017-11-29

Decision Date2017-11-29
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

s-Clean TiN Coating Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Dentis Co., Ltd.. It received FDA 510(k) clearance on 2017-11-29 under 510(k) number K171694. 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 s-Clean TiN Coating Abutments?

s-Clean TiN Coating Abutments is a medical device that received FDA 510(k) clearance on 2017-11-29. The listed applicant is Dentis Co., Ltd.. The 510(k) number is K171694.

When did s-Clean TiN Coating Abutments receive FDA 510(k) clearance?

s-Clean TiN Coating Abutments received FDA 510(k) clearance on 2017-11-29, under 510(k) number K171694.

Who is the listed applicant for s-Clean TiN Coating Abutments?

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

What is the FDA product code for s-Clean TiN Coating Abutments?

The FDA product code for s-Clean TiN Coating Abutments is NHA.

Other records listing Dentis 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.

View all 31 devices →

Related Devices (Code: NHA)

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.

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.