(70 days)
Air powered low speed dental motor that powers various dental attachments and accessories to facilitate procedure by the dental clinician during routine dental procedures.
Air powered low speed dental motor that powers various dental attachments and accessories to facilitate procedure by the dental clinician during routine dental procedures.
This document is a 510(k) summary for dental low-speed motors and attachments from Star Dental, submitted in 1996. It does not contain the type of acceptance criteria, study details, performance metrics, or ground truth information that your request is asking for.
The document focuses on demonstrating substantial equivalence to existing predicate devices based on:
- Similar materials: "Materials used to manufacture the components are similar."
- Identical means of operation: "Means of operation are identical, compressed air powers a variable speed rotary vane motor to provide power for various dental procedures."
- Virtually identical performance specifications: "The performance specifications are virtually identical."
- Minor differentiations: "The differentiation between the predicate device and the submitted one is more precise speed control, spring pre-loaded bearings."
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from the provided text because it describes a clearance process for a mechanical dental device based on substantial equivalence, not a diagnostic AI/ML device that would undergo the types of studies you've outlined.
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510(K) SUMMARY STAR DENTAL LOW SPEED MOTORS AND ATTACHMENTS
Company:
1
Star Dental, Division of Den-Tal-Ez, Inc. Owner/operator number 2520265
MAR 28 1996
Contact Person:
Jeff Peinhardt Quality Assurance Manager Star Dental, Division of Den-Tal-Ez, Inc. 1816 Colonial Village Ln. Lancaster, PA 17601 Phone (717) 291-1161 (717) 291-3249 Fax
Device Trade Name:
Star Dental TITAN Series Motors and Attachments
Common or Usual Name:
Low Speed Motors and Attachments
Predicate Devices:
Star Dental TITAN Series Motors and Attachments, Micro Motors, Nakinishi Dental, KAVO, and Lares low speed motors.
Description/Intended Use:
Air powered low speed dental motor that powers various dental attachments and accessories to facilitate procedure by the dental clinician during routine dental procedures.
Substantial Equivalence:
The Low Speed air-powered motor as submitted is substantially equivalent to other motors currently being marketed by, Micro Motors, Nakinishi Dental, KAVO, and Lares. Materials used to manufacture the components are similar. Means of operation are identical, compressed air powers a variable speed rotary vane motor to provide power for various dental procedures. The performance specifications are virtually identical. The differentiation between the predicate device and the submitted one is more precise speed control, spring pre-loaded bearings.
§ 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.