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K Number
K081237
Device Name
CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT
Manufacturer
CRAFTMASTER CONTOUR EQUIPMENT, INC.
Date Cleared
2008-08-25

(116 days)

Product Code
EIA
Regulation Number
872.6640
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The CCEI Vista, Satellite Mobile Unit and Satellite Unit are dental operative units that are intended to supply utilities to and serve as a base for dental tools and accessories.

Device Description

Not Found

AI/ML Overview

This 510(k) submission (K081237) is for the "Vista," "Satellite Mobile Unit," and "Satellite Unit" dental operative units. The provided documents do not contain any information regarding acceptance criteria or a study proving the device meets criteria related to performance metrics, statistical analysis, or comparison with a ground truth.

The submission focuses primarily on the administrative and regulatory aspects of marketing a Class I medical device. Key sections typically found in a submission discussing performance studies (e.g., performance data, clinical data, software validation) are absent from the provided text.

Based on the provided text, I cannot answer the requested questions. The document only confirms:

  • Device Name: Vista, Satellite Mobile Unit, Satellite Unit
  • Manufacturer: Craftmaster Contour Equipment, Inc.
  • Regulatory Class: I
  • Product Codes: EIA (primary), KLC (secondary)
  • Intended Use: To supply utilities to and serve as a base for dental tools and accessories.
  • Regulatory Status: Substantially equivalent to legally marketed predicate devices.

For Class I devices like this, the regulatory pathway often emphasizes general controls (e.g., good manufacturing practices, labeling) rather than extensive performance studies requiring the kind of data you've requested. The FDA's letter explicitly states that the device "does not require approval of a premarket approval application (PMA)," further indicating that detailed clinical or performance study data, as might be seen for Class II or III devices, are likely not a requirement for this specific submission.

§ 872.6640 Dental operative unit and accessories.

(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.