(52 days)
Both the predicate turbines and the proposed Star Dental replacement turbines are intended to be used as components to high speed handpieces, which are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings.
Star Dental Pushbutton Autochuck Replacement Turbine.
The provided text is a 510(k) summary for a dental device (Star Dental Pushbutton Autochuck Replacement Turbine). It describes the device, its intended use, and claims substantial equivalence to predicate devices.
However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth, expert opinions, or any of the other specific details requested in the prompt.
Therefore, I cannot provide the requested information. The 510(k) summary focuses on demonstrating equivalence to existing devices rather than presenting detailed performance studies against specific acceptance criteria.
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510(K) SUMMARY FOR STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE
Company:
Star Dental, Division of Den-Tal-Ez, Inc.
Contact Person:
Jeff Peinhardt Quality Assurance Manager Star Dental 1816 Colonial Village Ln. Lancaster, PA 17601
Phone (717) 291-1161 (717) 291-3249 Fax
Device Trade Name:
Star Dental Pushbutton Autochuck Replacement Turbine.
Common or Usual Name:
Replacement Turbine
Predicate Device(s):
Midwest Quiet-Air and Tradition model handpieces. Star Dental 430 series pushbutton autochuck turbine
Description/Intended Use:
Both the predicate turbines and the proposed Star Dental replacement turbines are intended to be used as components to high speed handpieces, which are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings.
Substantial Equivalence:
Both the predicate and the proposed Star Dental replacement turbines utilize the same technology, similar turbine design, manufacturing practices and materials. Substantial equivalence is achieved based on similarity in design and intended use.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.