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K Number
K992048
Device Name
MODIFICATION OF PROMPT L-POP
Manufacturer
ESPE DENTAL AG
Date Cleared
1999-08-16

(60 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Bonding between dentin/enamel and composite filling materials.

Bonding between dentin/enamel and compomer filling materials.

Bonding mediator for fissure sealing

Bonding mediator for bracket attachment

Device Description

РяомРт L-POP® is classified as a Resin Tooth Bonding Agent (21 С.F.R. § 872.3200) because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials (compomer and composite restorative material).

AI/ML Overview

I apologize, but the provided text from the 510(k) summary for PROMPT® L-POP® (K992048) describes a dental adhesive and does not contain information about acceptance criteria for a device, a study proving it meets such criteria, or details regarding AI algorithms, ground truth establishment, or multi-reader, multi-case (MRMC) studies.

The document focuses on:

  • Device identification: PROMPT® L-POP® (new formula), a resin tooth bonding agent.
  • Predicate device: The old formula of PROMPT® L-POP® (K 984246).
  • Reason for new 510(k): Expansion of indications for use to include bonding of composite restorative materials, in addition to compomer restorative materials.
  • Safety and effectiveness claims: Stating the new formula is similar to the old, with safety evidenced by material safety data sheets and a toxicological assessment, and effectiveness by performance data.
  • FDA clearance: A letter from the FDA confirming substantial equivalence to the predicate device for expanded indications.
  • Indications for use: Bonding between dentin/enamel and composite/compomer filling materials, fissure sealing, and bracket attachment.

Therefore, I cannot provide the requested information about acceptance criteria, performance tables, study details, sample sizes, ground truth, expert qualifications, or MRMC studies for an AI device. The document is about a dental adhesive and its regulatory clearance.

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.