STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES

K960507 · Dentalez Group · EFA · Mar 28, 1996 · Dental

Device Facts

• Record ID: K960507
• Device Name: STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES
• Applicant: Dentalez Group
• Product Code: EFA · Dental
• Decision Date: Mar 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

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.

Device Story

Replacement turbine for high-speed dental handpieces; component part. Used intraorally by trained dental professionals for cavity preparation and drilling. Device functions as mechanical rotary component within handpiece assembly. Enables removal of tooth structure for restorative procedures. Benefits patient by facilitating efficient dental cavity preparation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Mechanical turbine assembly; pushbutton autochuck mechanism. Materials and design consistent with predicate high-speed dental handpiece turbines.

Indications for Use

Indicated for use by trained dental professionals for intraoral drilling and preparation of dental cavities for restoration, such as fillings.

Regulatory Classification

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.

Predicate Devices

• Midwest Quiet-Air and Tradition model handpieces
• Star Dental 430 series pushbutton autochuck turbine

Submission Summary (Full Text)

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K960507

# 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 [phone]
Fax [phone]

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.

CONFIDENTIAL

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