MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN

K964863 · Bell Intl., Inc. · EBW · Feb 28, 1997 · Dental

Device Facts

• Record ID: K964863
• Device Name: MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN
• Applicant: Bell Intl., Inc.
• Product Code: EBW · Dental
• Decision Date: Feb 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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.

Device Story

Electric dental hand-engines and controllers; used for dental restoration and surgical applications. System comprises hand-engine, controller console, and foot switch. Input: electrical power (12VDC, 20VDC, or 30VDC). Transformation: controller regulates motor speed and direction of rotation; hand-engine drives industry-standard E-type front-handpieces. Output: mechanical rotation for dental tools. Used in dental clinics by dentists/staff. Healthcare provider operates foot switch to control speed/direction; output enables cavity preparation and tooth cleaning. Benefits: provides variable speed/torque for diverse dental procedures; allows use of various specialized front-handpieces.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Electric motor-driven hand-engines; 12VDC, 20VDC, or 30VDC power sources. Speed range 400-30,000 RPM. Torque 270-400 gm/cm. E-type connector interface. Foot-switch speed/direction control. Designed to meet UL-544 electrical safety standards. Non-sterilizable console/cords; surface disinfection only.

Indications for Use

Indicated for dental professionals to prepare dental cavities for restorations (e.g., fillings) and for cleaning teeth.

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

• 25-D hand engine and C-310 Console (K964863)

Submission Summary (Full Text)

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FEB 28 1997
K964863

| Section 510(k) Premarket Notification Summary of Safety and Effectiveness Information | For The Model 45E, Model 45EH, Model RX-100, Mark VIII, Mark IX, Mark X and Model Etelna II Dental Hand-engines and Controllers |
| --- | --- |

Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

1. Device Trade Name:
- Model 45E Handengine & Controller
- Model 45EH Handengine & Controller
- Model RX-100 Handengine & Controller
- Model Etelna II Handengine & Controller
- Model Bravo G-7 Handengine & Controller
- Mark VIII - Controller
- Mark IX - Controller
- Mark X - Controller

Common Name: Dental hand-engine & controllers

Classification Name: Dental handpiece and accessories

2. Establishment Name & Registration Number:

Name: BELL INTERNATIONAL, INC.

Number: 2921268

3. Classification:

§ 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. [55 FR 48439, Nov. 20, 1990].

Product Code(s): 76EBW

Device Class: Class I

Classification Panel: Dental

4. Equivalent / Predicate Device(s):

1. The 25-D hand engine and C-310 Console (Controller)

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# 5. Description of the Device:

This submission covers the BELL INTERNATIONAL, Inc. series of electric dental hand-engines. BELL INTERNATIONAL, Inc. offers a complete line of electric motor drive hand-engines for dental restoration and surgical applications.

The present BELL INTERNATIONAL, Inc. line of hand-engines is made up of the following devices:

| MODEL | SPEED | TORQUE | VOLTAGE | DIMEN. | WGHT. | CHUCK |
| --- | --- | --- | --- | --- | --- | --- |
| The 25D | 20K RPM | 320gm/cm | 20 VDC | 22x146mm | 150 gm. | 2.35mm |
| The 45E | 20K RPM | 320gm/cm | 30 VDC | 21x168mm | 150 gm. | 2.35mm |
| The 45EH | 30K RPM | 400gm/cm | 30 VDC | 24x168mm | 150 gm. | 2.35mm |
| The RX-100 | 30K RPM | 400gm/cm | 30 VDC | 24x168mm | 160 gm. | 2.35mm |
| The Etelna II | 20K RPM | 270ma/cm | 12 VDC | 23x140mm | 160 gm. | 2.35mm |
| The Bravo G-7 | 20K RPM | 270ma/cm | 12 VDC | 23x140mm | 160 gm. | 2.35mm |

The table below details the controller used with each hand-engine and any secondary hand-engines that are compatible.

| Console Controller | Primary Hand-engine | Console Speed Rating | Maximum Output | Secondary Hand-engine(s) |
| --- | --- | --- | --- | --- |
| C-310 Console | 25D | To 20K RPM | 20 VDC | NA |
| C-361 Console | 45E | To 20K RPM | 30 VDC | 45EH, RX-100 |
| C-361 Console | 45EH | To 30K RPM | 30 VDC | 45E, RX-100 |
| RX-100 Console | RX-100 | To 30K RPM | 30 VDC | 45E, 45EH |
| Mark VIII Console | 45EH | To 30K RPM | 30 VDC | RX-100 |
| Mark IX Console | 45EH | To 30K RPM | 30 VDC | RX-100 |
| Mark X Console | 45EH | To 30K RPM | 30 VDC | RX-100 |
| Etelna II Console | Etelna II | To 20K RPM | 12 VDC | Bravo G-7 |
| Bravo G-7 Console | Bravo G-7 | To 20K RPM | 12 VDC | Etelna II |

All engines have controllers equipped with Off/On and/or variable speed foot switches. The hand-engines accept various available "E-type connector" angled and straight front-handpieces produced by many different manufacturers. The different E-type front-handpieces are designed to do different types of dental work or surgical procedures. This includes those front-handpieces that multiply or reduce terminal shaft speed. The front-handpieces that are compatible with the Bell line of hand-engines are industry standard items and are covered by separate 510(k)s held by the manufacturers of those items.

# 12. Comparison to Predicate Device(s):

The 25-D hand engine and its attendant C-310 Console sold by Bell International, Inc. is a documented preamendment device and is the substantially equivalent comparison device for this submission. Each subsequent hand-engine and controller represent only minor variants of the original engine and controller.

There are essentially two main differences between the original device and the newer models. The original model contained a 20 VDC motor and the newer models contain a 30 VDC and 12 VDC. The original model accepted "D-type" front-handpiece connectors while the newer ones accept the more common "E-type" connectors. Two of the new models also operate at higher speed, 30,000 vs. 20,000 RPM and have marginally more torque.

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Other than the minor performance differences, the new controllers and hand-engines are substantially equivalent to the parent Model 25-D hand engine with C-310 Console. The Model 25D is a pre-amendment device, having been in commercial distribution since 1972.

The Model 25D along with its minor modification models, (the Mark VI-0 controller and the 45E hand-engine) has operating speeds of approximately 400 rpm to 20,000 rpm.

The 45E hand-engine was the first minor modification of the original design. It is the same basic 25D engine altered to accept the "E-type" handpiece connectors and was able to operate on 30 VDC current. The 45E produced the same amount of torque as the 25-D hand engine and had the same indications for use as well.

The 45EH and the RX-100 models are essentially the same as the 45E but produce more torque than either the original 25-D hand engine or the 45E. The 25D and the 45E offered 320 gram centimeters torque and the 45EH and RX-100 provide 400 gram centimeters torque. The 45EH and RX-100 also provide higher maximum RPM. Motor speeds for the 25D and 45E were limited to approximately 20,000 RPM and the 45EH and RX-100 can operate as high as 30,000 RPM. The indications for use remain unchanged.

The last change, incorporated into the Etelna II and the Bravo G-7, were to produce a lower cost "bare bones" unit that offered essentially the same level of performance as the 25D and the 45E. This was accomplished by using a lower cost 12 VDC motor. The Etelna II unit is also a portable battery operated unit while the Bravo G-7 unit is a wall current/transformer based unit.

The Mark VIII Controller is a space saving unit designed to be built into existing Air Power consoles located in the dentists office and will operate either the 45EH or the RX-100. The Mark IX unit operates the 45EH and has slightly increased power output of 35 VDC for Endodontic procedures. The Mark X is a space saving all icclusive foot-switch controller.

## 7. Modified Device Data:

Not applicable to this device. This submission covers a new device not a modified device.

## 8. Applicant / Sponsor Name / Address:

BELL INTERNATIONAL, INC.
31 Edwards Court
Burlingame, CA 94010

## 9. Contact Person:

Mr. Dewey Bell
BELL INTERNATIONAL, INC.
31 Edwards Court
Burlingame, CA 94010
[phone]
[phone]

## 10. Manufacturing Facility:

At the present time, all devices and controllers are purchased from recognized medical device manufacturers of handengines and controllers. All product specifications are checked and final QC inspections are conducted in-house by BELL INTERNATIONAL, INC.

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Comparison Table:

| FEATURE | 25-D hoodsagins w/C-310 Console | The Etelna II | Bravo G-7 | The RX-100 | The 45 EH | The 45E | SE? |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Intended Use | Engine, power supply and controller for dental handpiece | Engine, power supply and controller for dental handpiece | Engine, power supply and controller for dental handpiece | Engine, power supply and controller for dental handpiece | Engine, power supply and controller for dental handpiece | Engine, power supply and controller for dental handpiece | Yes |
| Forward & reverse switch | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Engine torque | 320 gram centimeters | 270 m/a max. | 270 m/a max. | 400 gram centimeters | 400 gram centimeters | 320 gram centimeters | Yes |
| Automatic Torque Limiting | No | No | No | No | No | Yes | No |
| Direct - remote selector switch | Yes | No | Yes | Yes | Yes | Yes | Yes |
| Speed Control | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Power Supply | 110-115 VAC, 50/60 Hz | 12 VDC via Battery & AC Charger | 12 VDC via 110-115 VAC, 50/60 Hz Transformer | 110-115 220-230 VAC, 50/60 Hz | 110-115 VAC, 50/60 Hz | 110-115 VAC, 50/60 Hz | Yes |
| UL/ETL Compliant | Yes - UL-544 | Yes - UL-544 | Yes - UL-544 | Yes - UL-544 | Yes - UL-544 | Yes - UL-544 | Yes |
| Console Model Compatible | C-310 | Etelna II | Bravo G-7 | C-361, Mark VIII & RX-100 Bat. Pack | C-361, Mark VIII, Mark IX & Mark X | C-361 | Yes |
| Can be used with Irrigation | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Digital speed readout | No | No | No | No | No | No | Yes |
| Voltage output | 2 - 20 volts DC | 12 VDC | 12 VDC | 3 - 30 VDC | 3 - 30 VDC | 3 - 30 vVDC | Yes |

## 12. Safety Standards:

All engines and controllers are designed to meet UL-544 (medical device) requirements for electrical safety.

## 13. Sterilization Information:

The device may not be sterilized. Surface disinfecting of the console, cords, foot switch and hand engine, cords and tubing may be accomplished using a number of available non-solvent based commercial germicidal or surface disinfectant preparations. Only the front handpiece of the dental drill may be sterilized.