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K Number
K990252
Device Name
SOLO PLUS ORTHO
Manufacturer
SYBRON DENTAL SPECIALTIES, INC.
Date Cleared
1999-02-25

(29 days)

Product Code
DYH
Regulation Number
872.3750
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Solo Plus Ortho is designed to be used as an enhancing primer for labial and lingual orthodontic bonding.

Device Description

The device is a universal primer for labial and lingual bonding of ceramic or metal brackets. Solo Plus Ortho may be light cured, using Solo Plus Ortho Primer A, or chemical cured using Solo Plus Ortho Primer A and Solo Plus Ortho Primer B.

AI/ML Overview

I am sorry, but the provided text Kaa052 does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary for a dental product called "Solo Plus Ortho," seeking substantial equivalence to existing devices. It focuses on device description, intended use, and regulatory classification, not on performance studies with specific statistical metrics.

Therefore, I cannot extract the requested information, including:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes for test sets or data provenance.
  • Number and qualifications of experts for ground truth.
  • Adjudication methods.
  • Results of any MRMC comparative effectiveness study.
  • Results of any standalone performance study.
  • Type of ground truth used.
  • Sample size for the training set.
  • How ground truth for the training set was established.

§ 872.3750 Bracket adhesive resin and tooth conditioner.

(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.