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K Number
K111199
Device Name
INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED ABUTMENTS
Manufacturer
INTRA-LOCK INTERNATIONAL, INC.
Date Cleared
2011-08-08

(102 days)

Product Code
NHA
Regulation Number
872.3630
Type
Traditional
Panel
DE
Reference & Predicate Devices
K103194
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Intra-Lock® 15° Angled Abutments are intended for use with Intra-Lock® dental implants to support a prosthetic device in partially or fully edentulous patients. The abutments may be used in single and/or multiple tooth application in the mandible or maxilla.

Device Description

The subject Intra-Lock® 15° Angled Abutment has a narrow prosthetic interface (SQ Platform) and therefore only mates with implants having SQ Platform. The SQ Platform abutments are anodized a magenta color.

AI/ML Overview

The provided text describes the 510(k) summary for the Intra-Lock® 15° Angled Abutment, a dental device, and does not contain information about an AI/ML powered medical device. Therefore, I cannot extract the acceptance criteria and study details as requested for an AI/ML device.

The document focuses on:

  • Device Identification: Name, common name, classification, and predicate devices.
  • Intended Use/Indications: To support prosthetic devices with Intra-Lock® dental implants in partially or fully edentulous patients.
  • Technological Characteristics: Narrow prosthetic interface (SQ Platform), magenta anodization.
  • Mechanical Testing: Static and dynamic fatigue testing in accordance with ISO 14801:2007.
  • Substantial Equivalence: Claim that the device is substantially equivalent to predicate devices based on design, materials, intended use, and operational principles, raising no new safety or effectiveness issues.

There is no mention of acceptance criteria related to algorithms, performance metrics like accuracy, sensitivity, specificity, or any studies involving AI/ML models, human readers, or ground truth establishment for such models.

§ 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.)