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FDA 510(k)

ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS

K-Number: K122268 · 2012-12-11

ApplicantDentsply International
Decision Date2012-12-11
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply International. It received FDA 510(k) clearance on 2012-12-11 under 510(k) number K122268. 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 ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS?

ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS is a medical device that received FDA 510(k) clearance on 2012-12-11. The listed applicant is Dentsply International. The 510(k) number is K122268.

When did ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS receive FDA 510(k) clearance?

ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS received FDA 510(k) clearance on 2012-12-11, under 510(k) number K122268.

Who is the listed applicant for ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS?

The FDA 510(k) record lists Dentsply International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS?

The FDA product code for ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS is NHA.

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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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