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TI PREPABLE ABUTMENT - 1619

FDA 510(k)

Class II (US FDA 510(k))

510(k) K092403

by Zimmer Dental Inc.

Identifiers

510(k) Number
K092403 FDA 510(k)
FDA Product Code
NHA FDA 510(k)
Models / Variants
1618 FDA 510(k)
1619 FDA 510(k)
1620 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)

TI PREPABLE ABUTMENT - 1619 by Zimmer Dental Inc. — Class II — FDA_510K — listed in FDA 510(k) — 3 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) K092403 24 fields · synced Jun 18, 2026