FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The LAMINOSS® Osteocompressive Implant System consists of a one-piece and twopiece immediately-loaded screw implants for the maxillary and mandibular arches to support fixed or removable prostheses.

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I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific criteria.

The document is a US FDA 510(k) clearance letter for the LaminOss® Dental Implant, indicating that the device has been found substantially equivalent to existing legally marketed devices. This letter does not contain details about performance studies, sample sizes, expert qualifications, or ground truth methodologies. It primarily focuses on regulatory approval based on equivalence.

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K Number

K933705

Device Name

LAMINOSS DENTAL IMPLANT

Manufacturer

IMPLADENT, LTD.

Date Cleared

1996-06-24

(1060 days)

Product Code