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.

AI/ML Overview

This looks like a 510(k) premarket notification for dental hand-engines and controllers. This type of submission is for medical devices, but it's not an AI/ML device, so many of the requested fields are not applicable.

Here's the information extracted and organized to the best of what's provided for a traditional medical device submission for this product:

Acceptance Criteria and Device Performance (Dental Hand-engines and Controllers)

The acceptance criteria for these dental hand-engines and controllers are implicitly tied to their "substantial equivalence" to a predicate device (the 25-D hand engine and C-310 Console), particularly in terms of intended use, operating characteristics, and safety standards. The study proving this typically takes the form of a comparison to the predicate device, demonstrating that the new devices perform as intended and do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, the "acceptance criteria" are generally that the devices perform comparably to or within acceptable limits of the predicate device for their stated specifications and intended use, and meet relevant safety standards.

Feature	Acceptance Criteria (Implied by Predicate Device (25-D handengine w/C-310 Console) and Safety Standards)	Reported Device Performance (New Devices)
Intended Use	Engine, power supply and controller for dental handpiece	All New Models: Engine, power supply and controller for dental handpiece (Substantially Equivalent)
Forward & Reverse Switch	Yes	All New Models: Yes (Substantially Equivalent)
Engine Torque	320 gram centimeters	Etelna II & Bravo G-7: 270 ma/cm max. (Slightly Lower than 25D, but considered "bare bones unit that offered essentially the same level of performance as the 25D and 45E") RX-100 & 45EH: 400 gram centimeters (Higher than 25D, considered minor variant) 45E: 320 gram centimeters (Substantially Equivalent)
Automatic Torque Limiting	No	All New Models: No (Substantially Equivalent)
Direct - Remote Selector Switch	Yes	Etelna II: No (Difference noted, but implied to be acceptable for "bare bones" functionality) Other New Models (Bravo G-7, RX-100, 45EH, 45E): Yes (Substantially Equivalent)
Speed Control	Yes	All New Models: Yes (Substantially Equivalent)
Power Supply	110-115 VAC, 50/60 Hz	Etelna II: 12 VDC via Battery & AC Charger (Portable, different from predicate but indicated as acceptable)Bravo G-7: 12 VDC via 110-115 VAC, 50/60 Hz Transformer ("bare bones," different from predicate but indicated as acceptable)RX-100: 110-115 / 220-230 VAC, 50/60 Hz (Broader range, functionally equivalent)45EH, 45E: 110-115 VAC, 50/60 Hz (Substantially Equivalent)
UL/ETL Compliant	Yes - UL-544	All New Models: Yes - UL-544 (Meets safety standard, crucial for acceptance)
Console Model Compatible	C-310	Etelna II: Etelna II Bravo G-7: Bravo G-7 RX-100: C-361, Mark VIII & RX-100 Bat. Pack 45EH: C-361, Mark VIII, Mark IX & Mark X 45E: C-361 (Specific console pairings are new but are deemed equivalent in functionality and safety with the overall system)
Can be used with Irrigation	Yes	All New Models: Yes (Substantially Equivalent)
Digital Speed Readout	No	All New Models: No (Substantially Equivalent)
Voltage Output	2 - 20 volts DC	Etelna II & Bravo G-7: 12 VDC (Lower than 25D, but indicated as acceptable for "bare bones" functionality)RX-100, 45EH, 45E: 3 - 30 VDC (Higher voltage range, but stated to be "substantially equivalent" for the higher speed models and within the range of previous models for the 45E)
Maximum RPM	20,000 RPM (for 25D)	Etelna II & Bravo G-7: To 20K RPM 45E: To 20K RPM RX-100, 45EH: To 30K RPM (Higher RPM, noted as minor variant, but not raising new safety/effectiveness concerns)
Accepts Connector Type	"D-type" front-handpiece connectors	All New Models: "E-type" connectors (This is a change but noted as an industry standard and covered by separate 510(k)s for the handpieces themselves, thus not affecting substantial equivalence of these devices as an engine/controller)

2. Sample Size Used for the Test Set and the Data Provenance

This document describes a substantial equivalence claim for medical devices, not a clinical study with a "test set" for performance evaluation in the way an AI/ML device would. The "test set" here is implicitly the new devices being compared to the predicate.

Sample Size: The "sample size" is the set of new devices (Model 45E, Model 45EH, Model RX-100, Model Etelna II, Model Bravo G-7 hand-engines and their associated controllers: C-361 Console, RX-100 Console, Mark VIII, Mark IX, Mark X, Etelna II Console, Bravo G-7 Console).
Data Provenance: The data provenance is from the manufacturer's specifications and comparison to a known pre-amendment device (25-D hand engine with C-310 Console) and other previously cleared devices that represent minor modifications (e.g., 45E). This is inherently retrospective, based on existing device knowledge, design specifications, and compliance with recognized standards. The country of origin of the data is not explicitly stated, but the manufacturer is Bell International, Inc. in Burlingame, CA, USA, suggesting a U.S. context for the documentation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

There is no mention of "experts" establishing a ground truth for a test set in a clinical evaluation sense. The "ground truth" for this type of submission is established through:

The performance and safety record of the predicate device (25-D hand engine and C-310 Console), which has been in commercial distribution since 1972.
Engineering specifications and testing by the manufacturer to ensure the new devices meet their stated performance characteristics and safety standards (e.g., UL-544 compliance).
Regulatory assessment by the FDA, relying on established classification regulations (§ 872.4200 for dental handpiece and accessories, Class I).

4. Adjudication Method for the Test Set

Not applicable for this type of device submission. There is no "adjudication method" in the context of clinical expert review for a test set as would be found in an AI/ML device evaluation. The assessment is regulatory by the FDA based on the provided technical documentation and comparison to the predicate.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" used for this submission is based on:

Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate device (Bell International, Inc.'s 25-D hand engine and C-310 Console), which is a pre-amendment device.
Manufacturer Specifications and Engineering Data: The design specifications, physical characteristics, and measured performance (e.g., speed, torque, voltage) of the new devices, along with internal quality control and testing results (e.g., UL-544 compliance).
Regulatory Standards: Compliance with recognized electrical safety standards like UL-544.
Intended Use Equivalence: Demonstration that the new devices do not have different intended uses or raise different questions of safety and effectiveness compared to the predicate.

8. The sample size for the training set

Not applicable. This is not an AI/ML device and does not involve a "training set" in that context.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device and does not involve establishing ground truth for a "training set."

Summary

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K964863

Section 510(k) Premarket NotificationSummary of Safety and EffectivenessInformation	For The Model 45E, Model 45EH, ModelRX-100, Mark VIII, Mark IX, Mark X andModel Etelna II Dental Hand-engines andControllers
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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)

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5. Description of the Device:

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 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 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.

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.

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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 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.

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Comparison Table:

FEATURE	25-Dhandenginew/C-310 Console	The Etelna II	Bravo G-7	The RX-100	The 45 EH	The 45E	SE?
Intended Use	Engine, power supplyand controller fordental handpiece	Engine, powersupply andcontroller fordental handpiece	Engine, powersupply andcontroller fordentalhandpiece	Engine, powersupply andcontroller fordentalhandpiece	Engine, powersupply andcontroller fordentalhandpiece	Engine,power supplyand controllerfor dentalhandpiece	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 gramcentimeters	400 gramcentimeters	320 gramcentimeters	Yes
AutomaticTorqueLimiting	No	No	No	No	No	Yes	No
Direct - remoteselector switch	Yes	No	Yes	Yes	Yes	Yes	Yes
Speed Control	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Power Supply	110-115 VAC, 50/60Hz	12 VDC viaBattery & ACCharger	12 VDC via110-115 VAC.50/60 HzTransformer	110-115220-230 VAC.50/60 Hz	110-115 VAC.50/60 Hz	110-115VAC, 50/60Hz	Yes
UL/ETLCompliant	Yes - UL-544	Yes - UL-544	Yes - UL-544	Yes - UL-544	Yes - UL-544	Yes - UL-544	Yes
Console ModelCompatible	C-310	Etelna II	Bravo G-7	C-361. MarkVIII & RX-100Bat. Pack	C-361. MarkVIII, Mark IX &Mark X	C-361	Yes
Can be usedwith Irrigation	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Digital speedreadout	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.

Regulation Number and Section

§ 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.