FDA 510(k)

HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5,

K-Number: K090723 · 2009-04-07

Decision Date2009-04-07

Product CodeNHA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5, is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Dental, Inc.. It received FDA 510(k) clearance on 2009-04-07 under 510(k) number K090723. 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 HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5,?

HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5, is a medical device that received FDA 510(k) clearance on 2009-04-07. The listed applicant is Zimmer Dental, Inc.. The 510(k) number is K090723.

When did HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5, receive FDA 510(k) clearance?

HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5, received FDA 510(k) clearance on 2009-04-07, under 510(k) number K090723.

Who is the listed applicant for HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5,?

The FDA 510(k) record lists Zimmer Dental, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5,?

The FDA product code for HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5, is NHA.

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Other records listing Zimmer Dental, Inc. as applicant

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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.