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K Number
K080397
Device Name
AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM
Manufacturer
AMERICAN DENTAL IMPLANT CORPORATION
Date Cleared
2008-05-06

(83 days)

Product Code
NHA
Regulation Number
872.3630
Type
Traditional
Panel
Dental
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The American Dental Implant System is intended to be used in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients. As per Part 21, CFR 801 Subpart D, this item is for Prescription Use and as such is only sold on or by the order of a licensed dentist.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and study proving device performance for the "American Dental Implant Abutment System."

The document is a 510(k) clearance letter from the FDA, which confirms the device's substantial equivalence to a legally marketed predicate device. It defines the device name, regulation number, regulatory class, and lists the "Indications for Use."

However, it does not include:

  • A table of acceptance criteria and reported device performance.
  • Details about sample size, data provenance, or the number/qualifications of experts used for ground truth.
  • Adjudication methods.
  • Information on multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.
  • The type of ground truth used (e.g., pathology, outcomes data).
  • Sample size for the training set or how its ground truth was established.

This type of information is typically found in the 510(k) submission itself, supporting studies, or a more detailed technical report, rather than in the FDA clearance letter.

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)