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HEX-LOCK SHORT ABUTMENT - Saheal5

FDA 510(k)

Class II (US FDA 510(k))

510(k) K090723

by Zimmer Dental Inc.

Identifiers

510(k) Number
K090723 FDA 510(k)
FDA Product Code
NHA FDA 510(k)
Models / Variants
Sa341 FDA 510(k)
Sa342 FDA 510(k)
Sa451 FDA 510(k)
Sa452 FDA 510(k)
Sa561 FDA 510(k)
Model Saheal4 FDA 510(k)
Saheal5 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3630 FDA 510(k)
Regulation Number
872.3630 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

HEX-LOCK SHORT ABUTMENT - Saheal5 by Zimmer Dental Inc. — Class II — FDA_510K — listed in FDA 510(k) — 8 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Zimmer Dental Inc.
FDA Applicant
Zimmer Dental, Inc.

Sources (1)

  • FDA 510(k) K090723 24 fields · synced Jun 18, 2026