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K Number
K012742
Device Name
TEETHMATE F-1
Manufacturer
KURARAY MEDICAL INC.
Date Cleared
2001-09-14

(31 days)

Product Code
EBC
Regulation Number
872.3765
Type
Traditional
Panel
DE
Reference & Predicate Devices
K965091
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

TEETHMATE F-1 is indicated for the following application: 1) Pit and fissure sealant

Device Description

This product is classified into the pit and fissure sealant and conditioner, CFR 21 Section 872.3765, because it is a device composed of resin, such as polymethyl methacrylate, intended for use primary in young children to seal pit and fissure depressions in the biting surfaces of teeth to present cavities.

AI/ML Overview

There is insufficient information within the provided text to describe acceptance criteria and a study proving a device meets these criteria. The document is a 510(k) summary for a dental material (TEETHMATE F-1), which primarily addresses its substantial equivalence to a predicate device for marketing purposes. It does not contain details about performance acceptance criteria or specific studies to demonstrate compliance.

The document discusses:

  • Device Identification: TEETHMATE F-1, a pit and fissure sealant.
  • Submission Purpose: To change the name and address of the manufacturer (Kuraray Co., Ltd. transferring business to Kuraray Medical Inc.).
  • Predicate Device: TEETHMATE F-1 by Kuraray Co., Ltd. (K965091).
  • Intended Use: Pit and fissure sealant.
  • Technological Characteristics and Safety: Stated as "completely the same" as the predicate device.
  • FDA Correspondence: Notification of substantial equivalence determination.

None of these sections detail performance metrics, acceptance criteria, or specific study designs (like sample sizes, expert qualifications, adjudication methods, or MRMC studies) related to the device's performance. The FDA's letter merely confirms the substantial equivalence determination based on the provided information, not necessarily on new performance studies.

§ 872.3765 Pit and fissure sealant and conditioner.

(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.