Lorenz Surgical Threaded Dental Implant
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K941619 FDA 510(k)
- FDA Product Code
- DZE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3640 FDA 510(k)
- Regulation Number
- 872.3640 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Lorenz Surgical Threaded Dental Implant is a dental device designed for surgical implantation. It serves as a threaded implant intended for use in dental procedures.
This device is identified by K-number K941619 and has received FDA 510(k) clearance. It is manufactured by Biomet, Inc. and is classified under the dental product code DZE.
Frequently asked questions
What is the intended use of the Lorenz Surgical Threaded Dental Implant?
This device is a threaded dental implant specifically designed for use in surgical dental procedures to support restorative dentistry.
What is the regulatory status of this dental implant?
The Lorenz Surgical Threaded Dental Implant has received FDA 510(k) clearance under the submission number K941619, confirming it is substantially equivalent to legally marketed predicate devices.
Who is the manufacturer of this dental implant?
This device is manufactured by Biomet, Inc., located in Warsaw, Indiana, and is classified under the dental product code DZE.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: LORENZ SURGICAL THREADED DENTAL IMPLANT (K941619) - FDA 510(k), LORENZ SURGICAL THREADED DENTAL IMPLANT (K941619) — FDA 510 (k ..., Lorenz Surgical Threaded Dental Implant - Beudamed, PDF K941619 - Lorenz Surgical Threaded Dental Implant, PDF 00 CatalogCovers - W. Lorenz
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K941619 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K941619 24 fields · synced Sep 25, 2026