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K Number
K180199
Device Name
BIO-C TEMP
Manufacturer
Angelus Industria de Produtos Odontologicos S/A
Date Cleared
2019-01-04

(345 days)

Product Code
KIF
Regulation Number
872.3820
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • Intracanal dressing for endodontic treatment of pulp necrosis and retreatments.
  • Intracanal dressing in cases of perforations, external and internal resorptions, prior to the use of MTA ANGELUS OR MTA REPAIR HP.
  • For the treatment of incomplete root formation (rizogenesis):
    Apexification - the formation of the apex in cases of pulp necrosis;
    Apexigenesis - the formation of the apex in cases of vital pulp.
Device Description

Not Found

AI/ML Overview

The provided text does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA clearance letter for a dental device called "BIO-C TEMP," which is a root canal filling resin.

The letter primarily covers:

  • The FDA's review and determination of substantial equivalence for the device.
  • Regulatory information, including general controls, classification, and applicable regulations.
  • Contact information for FDA resources.
  • The indications for use for the BIO-C TEMP device.

Therefore, I cannot provide the requested information, including:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size and data provenance for a test set.
  3. Number and qualifications of experts for ground truth establishment.
  4. Adjudication method for a test set.
  5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Results of a standalone algorithm 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.

§ 872.3820 Root canal filling resin.

(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.