← Product Code [EFA](/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA) · K960260

# STAR TITAN SERIES MOTORS & ATTACHMENTS (K960260)

_Dentalez Group · EFA · Mar 28, 1996 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA/K960260

## Device Facts

- **Applicant:** Dentalez Group
- **Product Code:** [EFA](/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA.md)
- **Decision Date:** Mar 28, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.4200
- **Device Class:** Class 1
- **Review Panel:** Dental

## 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.

## Device Story

Air-powered low-speed dental motor; powers various dental attachments/accessories; used by dental clinicians during routine procedures; operates via compressed air driving variable speed rotary vane motor; features precise speed control and spring pre-loaded bearings; provides rotational power for dental instrumentation.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

Air-powered rotary vane motor; variable speed control; spring pre-loaded bearings; metallic construction; pneumatic energy source.

## Regulatory 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 TITAN® Series Motors and Attachments
- Micro Motors low speed motors
- Nakinishi Dental low speed motors
- KAVO low speed motors
- Lares low speed motors

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
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K960260

# 510(K) SUMMARY
## STAR DENTAL LOW SPEED MOTORS AND ATTACHMENTS

### Company:
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
Fax (717) 291-3249

### 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.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA/K960260](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFA/K960260)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

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