Laminoss Dental Implant
FDA 510(k)Class II (US FDA 510(k))
by Impladent
Identifiers
- 510(k) Number
- K982925 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 Laminoss Dental Implant is an osteocompressive immediate-load implant designed for dental applications. It features a sinusoidal thread structure engineered to minimize shear interface and function within horizontal planes.
This device is manufactured by Impladent, Ltd. and has received FDA 510(k) clearance. It is identified under product code DZE and is associated with regulatory submission K982925.
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: (PDF) LaminOss Immediate-Load Implants: II. Clinical ... - ResearchGate, Impladent , Ltd. FDA 510 (k) Products (1996-2014), K933705 FDA 510(k) - LAMINOSS DENTAL IMPLANT | Impladent , Ltd., LAMINOSS DENTAL IMPLANT (K933705) — FDA 510(k) | Innolitics, LaminOss Immediate-load Implants: II. Clinical Considerations of ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K982925 | Class II | Active |
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Manufacturer
- Manufacturer
- Impladent
- FDA Applicant
- Impladent , Ltd.
Sources (1)
- FDA 510(k) K982925 24 fields · synced Sep 26, 2026