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K Number
K021450
Device Name
CLINPRO PROPHY POWDER
Manufacturer
3M ESPE AG DENTAL PRODUCTS
Date Cleared
2002-08-01

(87 days)

Product Code
KOJ
Regulation Number
872.6080
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Clinpro™ Prophy Powder is intended for use in dental polishing units. The air polishing unit produces a stream of water, air and Clinpro Prophy Powder to clean and polish tooth surfaces.
Cleaning, polishing and restoring the natural esthetics of tooth enamel

Device Description

Clinpro Prophy Powder is classified as a class II medical device because it is a device intended for use during dental cleaning and periodontal therapy to remove deposits and stains from teeth (Ultrasonic Scaler, 21 C.F.R. § 872.4850). Clinpro Prophy Powder is intended for use in dental polishing units. The air polishing unit produces a stream of water, air and Clinpro Prophy Powder to clean and polish tooth surfaces.

AI/ML Overview

The provided text describes a 510(k) summary for a dental cleaning powder, Clinpro™ Prophy Powder, and its substantial equivalence determination by the FDA. However, it does not contain the information required to populate the requested table and answer the questions related to acceptance criteria, device performance, and study details for an AI/software device.

The document discusses:

  • Device Name: Clinpro™ Prophy Powder
  • Classification: Class II medical device, Ultrasonic Scaler (21 C.F.R. § 872.4850), later identified as Airbrush (21 CFR 872.6080)
  • Intended Use: Cleaning, polishing, and restoring the natural aesthetics of tooth enamel; specifically for use in dental polishing units to produce a stream of water, air, and powder to clean and polish tooth surfaces.
  • Predicate Device: New Prophy Powder by Dentsply (K014188)
  • Conclusion: The submitter believes the device is substantially equivalent to the predicate device and that performance and biocompatibility data provide evidence that safety and effectiveness requirements are met.

There is no mention of:

  • Acceptance criteria in terms of metrics (e.g., sensitivity, specificity, accuracy).
  • Reported device performance values for such metrics.
  • Any clinical study, test set, training set, or ground truth details.
  • AI/software components, human readers, or comparative effectiveness studies.

Therefore, I cannot fulfill the request as the provided text is for a physical dental cleaning powder undergoing a 510(k) submission, not an AI/software device evaluation.

§ 872.6080 Airbrush.

(a)
Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.(b)
Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”