MARK 20 AND MARK 25 HAND ENGINE CONTROLLER

K964860 · Bell Intl., Inc. · EBW · Mar 3, 1997 · Dental

Device Facts

• Record ID: K964860
• Device Name: MARK 20 AND MARK 25 HAND ENGINE CONTROLLER
• Applicant: Bell Intl., Inc.
• Product Code: EBW · Dental
• Decision Date: Mar 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Engine, power supply and controller for dental handpiece

Device Story

Mark 20 and Mark 25 are dental handpiece controllers operating 45E and RX-100 low-voltage DC-motor handengines. Devices function as rheostat-based power supplies, providing speed and direction control for dental/endodontic procedures. Inputs include user settings via local controls or remote foot switch; outputs include regulated DC power to handengines and irrigation fluid delivery. Mark 20 features constant-speed irrigation; Mark 25 features variable-speed irrigation. Used in clinical dental settings by practitioners to drive various angled or straight front handpieces. Output allows practitioners to perform cavity preparation and cleaning; increased torque (400 g-cm) compared to predicate improves performance for surgical procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Rheostat-based controller; AC-powered (110-115 VAC, 50/60 Hz); output 3-30 VDC. Compatible with 45E and RX-100 DC-motor handengines. Features include forward/reverse switching, local/remote foot switch control, and integral fluid pump for irrigation. Digital speed readout included. Designed to meet UL-544 medical electrical safety standards. Non-sterilizable console; surface disinfection recommended.

Indications for Use

Indicated for use as a power supply and controller for dental handpieces to prepare dental cavities for restorations 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 (Controller)

Submission Summary (Full Text)

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K964860
MAR - 3 1997

| Section 510(k) Premarket Notification
Summary of Safety and Effectiveness Information | Mark 20 and Mark 25
Irrigating Handengine Controller |
| --- | --- |

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

1. Device Trade Name: Mark 20 and Mark 25 Hand Engine Controller

Common Name: Dental handpiece controller

Classification Name: Dental handpiece and accessories

2. Establishment Name & Registration Number:

Name: BELL INTERNATIONAL

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)

5. Description of the Device:

The new device submission covers two handengine controllers designed to operate the 45E and RX-100 dental handengines. The 45E and the RX-100 are low-voltage DC-motors with E-connector type front ends. Both the 45E and the RX-100 may be operated by the Mark 20 or Mark 25 Controller. Both engines have Off/On or variable speed footswitches. Both engines accept various angled and straight front handpieces on the motor to do different types of dental work or surgical procedures.

The 45E and the RX-100 produce more torque than the original 25D handengine. The 25D offered 320 gram centimeters and the 45EH and RX-100 offer 400 gram centimeters torque.

The Mark 20 and Mark 25 Controllers are typical rheostat based hand engine controllers. The Mark 20 or Mark 25 Controller allows the practitioner infinite control over the speed of the engine and dental front handpiece up to the rated speed capacity of the selected engine and

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handpiece. Both the Mark 20 and Mark 25 Controller allow the selected hand engine and dental front hand piece to be operated in forward or reverse directions as well as by local control or remote foot switch. Dental or endodontic surgical procedures needing irrigation are supported by the integral fluid pump. The pump is constant speed in the Mark 20 and is variable speed in the Mark 25 unit.

## 6. Comparison to Predicate Device(s):

The new controllers and handengines 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 model, the Mark VI-0 controller has operating speeds of approximately 400 rpm to 20,000 rpm.

The 25D handengine produces torque values of 320 grams centimeters, it is powered by direct current from 3 to 20 volts and it accommodates a ISO chuck of 2.35mm.

The 45EH handengine has a operating range from 1500 to 30,000 rpm and produces torque values of 400 grams centimeters, it operates from 3 to 30 volts direct current and takes a ISO chuck of 2.35mm.

The RX-100 handengine has a operating range from 1500 to 30,000 rpm and produces torque values of 400 grams centimeters, it operates from 3 to 30 volts direct current and takes a ISO chuck of 2.35mm.

The Mark 20 and Mark 25 Controllers are substantially equivalent to the C-310 Console Controller supplied with the predicate device sold by Bell International as the 25-D hand engine with C-310 Console. The important difference between the C-310 Console Controller and the Mark 20 and Mark 25 Controllers is the modest difference in control features and the availability of surgical irrigation.

## 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, the Mark 20 and Mark 25 Controller are manufactured in-house by BELL INTERNATIONAL, INC.

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# 11. Comparison Table:

| FEATURE | Mark 20 Controller | Mark 25 Controller | 25-D hand engine w/ C-310 Console | 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 | Yes |
| Forward & reverse switch | Yes | Yes | Yes | Yes |
| Engine torque | 400 gram centimeters | 400 gram centimeters | 320 gram centimeters | no |
| Automatic Torque Limiting | No | Yes | No | No |
| Direct - remote selector switch | Yes | Yes | Yes | Yes |
| Speed Control | Yes | Yes | Yes | Yes |
| Power Supply | AC - 110-115 VAC, 50/60 Hz | AC - 110-115 VAC, 50/60 Hz | AC - 110-115 VAC, 50/60 Hz | Yes |
| UL/ETL Compliant | Yes - UL-544 | Yes - UL-544 | Yes - UL-544 | Yes |
| Engine Models | 45E hand engine - RX-100 | 45E hand engine - RX-100 | 25D hand engine | Yes |
| Irrigation Support | Yes - Constant speed | Yes - Variable speed | None | No |
| Digital speed readout | Yes | Yes | No | No |
| Voltage output | 3 - 30 volts DC | 3 - 30 volts DC | 2 - 20 volts DC | Yes |

# 12. Safety Standards:

The Mark 20 and Mark 25 Controller 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 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.