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K Number
K031793
Device Name
DENTATUS OSCIOMAT
Manufacturer
DENTATUS USA, LTD.
Date Cleared
2003-11-13

(156 days)

Product Code
DZH
Regulation Number
872.4120
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Dentatus Osciomat is intended for use in preparing bone in conjunction with dental and craniofacial surgical procedures.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA for a dental device called the "Dentatus Osciomat." It primarily focuses on regulatory approval and does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance.
  3. Number and qualifications of experts.
  4. Adjudication method.
  5. MRMC comparative effectiveness study.
  6. Standalone performance study.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This document is a regulatory approval letter, confirming that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has been deemed safe and effective based on existing devices, not necessarily a new clinical study with performance metrics in this specific filing.

§ 872.4120 Bone cutting instrument and accessories.

(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.