(89 days)
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No
The description focuses on rheostat-based control of dental handengines and a fluid pump, with no mention of AI or ML technologies.
No
The device is a controller for dental handpieces, which are used to perform dental work or surgical procedures, but the controller itself does not directly apply therapy.
No
The device, a controller for dental handengines, is described as operating various handpieces for dental work or surgical procedures, and is not performing diagnostic functions.
No
The device description explicitly details hardware components like controllers, motors, footswitches, and a fluid pump, indicating it is a physical medical device, not software-only.
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 to power and control dental handpieces for dental work or surgical procedures. This is a direct interaction with the patient's body (or tissues within the body), not an examination of specimens taken from the body.
- Device Description: The description details a system for operating dental handpieces, including motors, controllers, and a fluid pump for irrigation. These are all components used in direct clinical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting diseases or conditions based on such analysis, or providing information for diagnosis based on in vitro testing.
Therefore, this device falls under the category of a medical device used for direct patient treatment or procedures, not an in vitro diagnostic device.
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
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 Econnector type front ends. Both 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 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 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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 (Controller) 1.
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.
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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).
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§ 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.
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ction 510(k) Premarket Notification Summary of Safety and Effectiveness Information
Mark 20 and Mark 25 Irrigating Handengine Controller
Requlatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
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- Device Trade Name: Mark 20 and Mark 25 Hand Engine Controller
Dental handpiece controller Common Name:
- Device Trade Name: Mark 20 and Mark 25 Hand Engine 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 contraangle 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):
The 25-D hand engine and C-310 Console (Controller) 1.
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 Econnector type front ends. Both 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 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
1
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 it's 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 (415) 348-2055 (415) 348-3937
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 meets 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.