STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE

K960719 · Dentalez Group · EFA · Mar 28, 1996 · Dental

Device Facts

• Record ID: K960719
• Device Name: STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE
• 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

Indications for Use

High speed dental handpieces are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings.

Device Story

High speed dental handpiece; used intraorally by dental professionals; performs drilling and preparation of dental cavities for restoration; device functions as mechanical tool for tooth structure removal; clinical benefit includes efficient cavity preparation for restorative procedures.

Clinical Evidence

No clinical data; substantial equivalence based on design and material similarity to predicate.

Technological Characteristics

High speed dental handpiece; mechanical design; materials and manufacturing processes equivalent to predicate.

Indications for Use

Indicated for intraoral use by trained dental professionals for 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

• Star Dental 430 Series High Speed Handpiece (K960719)

Submission Summary (Full Text)

{0}

K960719
K960719
MAR 28 1966

# STAR DENTAL HIGH SPEED HANDPIECE

## 510(k) Summary

Company:
Star Dental, Division of Den-Tal-Ez, Inc.
Owner/operator number 2520265

Contact Person:
Jeff Peinhardt
Quality Assurance Manager
Star Dental, Division of Den-Tal-Ez, Inc.
1816 Colonial Village Ln.
Lancaster, PA 17601
Phone [phone]
Fax [phone]

Device Trade Name:
430 Series High Speed Handpiece

Common or Usual Name:
High Speed Handpiece

Predicate Device:
Star Dental 430 Series High Speed Handpiece

Intended Use/Description:
High speed dental handpieces are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings. The intended use of the device is identical to that of the predicate. The technology, design, manufacturing, and materials are substantially equivalent to those of other handpieces on the market, including that of the current 430 series handpiece.

Substantial Equivalence:
The determination of substantial equivalence is based on the fact that the proposed Star Dental device and the predicate Star Dental device utilize substantially equivalent intended use, technology, design, manufacturing, and materials and so will be substantially equivalent in clinical performance.

14