LogoFDA 510(k) Search
K Number
K081514
Device Name
TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER
Manufacturer
LANG DENTAL MFG. CO., INC.
Date Cleared
2008-09-22

(115 days)

Product Code
EBI
Regulation Number
872.3760
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

LANG DENTAL TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN is intended for the fabrication of denture relines.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document, I cannot answer the request. The document is a 510(k) clearance letter from the FDA for a dental device, specifically "Lang Dental Tempo Cushion Treatment Denture Reline Acrylic Resin." This type of document confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed.

However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or performance testing summaries. The letter only states that the device is "substantially equivalent" to existing devices for the purpose of "fabrication of denture relines."

Therefore, I cannot extract the following information from this document:

  1. A table of acceptance criteria and the reported device performance
  2. Sample sized used for the test set and the data provenance
  3. Number of experts used to establish the ground truth for the test set and their qualifications
  4. Adjudication method
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
  6. If a standalone performance study was done
  7. The type of ground truth used
  8. The sample size for the training set
  9. How the ground truth for the training set was established

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.