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K Number
K051797
Device Name
FUTURE WASH/YPS
Manufacturer
3M ESPE AG DENTAL PRODUCTS
Date Cleared
2005-07-21

(16 days)

Product Code
ELW
Regulation Number
872.3660
Type
Special
Panel
DE
Reference & Predicate Devices
K000588,K000591
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Future Wash (Future Wash Light Body, Future Wash Light Body Quick Step, Future Wash Regular Body, Future Wash Regular Body Quick Step): Wash material for all kinds of dual phase impression techniques.

YPS (YPS Penta™ HB Quick Step): Tray material for all kinds of dual phase impression techniques.

Device Description

Future Wash and YPS are classified as Impression materials (21 C.F.R. § 872.3660) because they are devices intended to reproduce the structure of a patient's teeth.

Future Wash will be available as wash material in two different viscosities (light body, regular body), each of them in a regular-sct and a quick-set version, and YPS will be a tray material in a quick-set version.

The Future Wash materials are two component (base paste/catalyst) materials designed to be used in 3M ESPE's mixing, dosing and dispensing device, Garant™. YPS is a two component (base paste/catalyst) materials to automatically be mixed and dispensed in the 3M ESPE's Pentamix™ 2 device.

AI/ML Overview

The provided text is a 510(k) summary for dental impression materials (Future Wash and YPS Penta™), not a study demonstrating a device meets acceptance criteria. It discusses the substantial equivalence of the new devices to predicate devices. Therefore, I cannot extract the specific information requested about acceptance criteria and a study proving device performance as such a study is not detailed in the provided text.

The information provided confirms:

  • The devices are dental impression materials.
  • The submission is a special 510(k) for modifications to existing silicone impression materials.
  • Biocompatibility testing was carried out to provide evidence for safety.
  • Performance characteristics were compared to predicate devices to prove effectiveness.
  • The conclusion is that the new devices are substantially equivalent to their predicate devices.

However, the summary does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes for a test set, data provenance, or details on retrospective/prospective studies.
  3. The number or qualifications of experts used for ground truth.
  4. Adjudication methods.
  5. Details of a multi-reader multi-case (MRMC) comparative effectiveness study, effect sizes, or human reader improvement with/without AI assistance.
  6. Details of a standalone algorithm-only performance study.
  7. The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

Therefore, I cannot fulfill the request based on the provided text.

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).