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FDA 510(k)

ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS

K-Number: K101068 · 2010-08-23

ApplicantRadiant Express, LLC
Decision Date2010-08-23
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Radiant Express, LLC. It received FDA 510(k) clearance on 2010-08-23 under 510(k) number K101068. 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 ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS?

ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS is a medical device that received FDA 510(k) clearance on 2010-08-23. The listed applicant is Radiant Express, LLC. The 510(k) number is K101068.

When did ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS receive FDA 510(k) clearance?

ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS received FDA 510(k) clearance on 2010-08-23, under 510(k) number K101068.

Who is the listed applicant for ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS?

The FDA 510(k) record lists Radiant Express, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS?

The FDA product code for ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS is NHA.

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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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