K Number
K964863
Device Name
MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN
Manufacturer
Date Cleared
1997-02-28

(86 days)

Product Code
Regulation Number
872.4200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Engine, power supply and controller for dental handpiece
Device Description
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 handengines 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.
More Information

The 25-D hand engine and C-310 Console

Not Found

No
The document describes a mechanical dental hand-engine and controller, with no mention of AI, ML, image processing, or data-driven performance metrics.

Yes.
The device is described as an "engine, power supply and controller for dental handpiece" used in "dental restoration and surgical applications," which are therapeutic procedures.

No
The device description states it is an "engine, power supply and controller for dental handpiece" used for "dental restoration and surgical applications." These functions are therapeutic or operative, not diagnostic.

No

The device description explicitly states it is a series of "electric dental hand-engines," which are hardware components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use/Indications for Use: The intended use is "Engine, power supply and controller for dental handpiece." This describes a device used for mechanical procedures within the mouth, not for testing samples taken from the body.
  • Device Description: The description details a system for powering and controlling dental handpieces used for "dental restoration and surgical applications." This aligns with a device used directly on a patient for treatment, not for in vitro testing.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely mechanical and procedural within the oral cavity.

N/A

Intended Use / Indications for Use

Engine, power supply and controller for dental handpiece

Product codes (comma separated list FDA assigned to the subject device)

76EBW

Device Description

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

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 handengines 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 handengines are industry standard items and are covered by separate 510(K)s held by the manufacturers of those items.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

The 25-D hand engine and C-310 Console

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

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 |

---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Requlatory 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

Dental hand-engine & controllers Common Name:

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 beit-driven, hand-held device that may include a foot controller for requlation 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 !

Classification Panel: Dental

4. Equivalent / Predicate Device(s):

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

1

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.

MODELSPEEDTORQUEVOLTAGEDIMEN.WGHT.CHUCK
The 25D20K RPM320gm/cm20 VDC22x146mm150 gm.2.35mm
The 45E20K RPM320gm/cm30 VDC21x168mm150 gm.2.35mm
The 45EH30K RPM400gm/cm30 VDC24x168mm150 gm.2.35mm
The RX-10030K RPM400gm/cm30 VDC24x168mm160 gm.2.35mm
The Etelna II20K RPM270ma/cm12 VDC23x140mm160 gm.2.35mm
The Bravo G-720K RPM270ma/cm12 VDC23x140mm160 gm.2.35mm

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

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

Console ControllerPrimary Hand-engineConsole Speed RatingMaximum OutputSecondary Hand-engine(s)
C-310 Console25DTo 20K RPM20 VDCNA
C-361 Console45ETo 20K RPM30 VDC45EH, RX-100
C-361 Console45EHTo 30K RPM30 VDC45E, RX-100
RX-100 ConsoleRX-100To 30K RPM30 VDC45E, 45EH
Mark VIII Console45EHTo 30K RPM30 VDCRX-100
Mark IX Console45EHTo 30K RPM30 VDCRX-100
Mark X Console45EHTo 30K RPM30 VDCRX-100
Etelna II ConsoleEtelna IITo 20K RPM12 VDCBravo G-7
Bravo G-7 ConsoleBravo G-7To 20K RPM12 VDCEtelna II

All engines have controllers equipped with Off/On and/or variable speed foot switches. The handengines 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 handengines 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 hond eagine 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.

2

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 it's 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 25E 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 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 (415) 348-2055 (415) 348-3937

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.

3

Comparison Table:

| FEATURE | 25-D
handengine
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 VDC | Yes |

12. Safety Standards:

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

13. Sterilization Information:

The device may not be sterilized. Sufface 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.