(307 days)
No
The device description focuses on providing basic utilities (air, water, power, vacuum) and mechanical controls for dental instruments. There is no mention of AI/ML terms, image processing, or data analysis that would suggest AI/ML capabilities. The "preprogramed cleaning functions" are described as automatic but not indicative of AI/ML.
No.
The device acts as a base and power supply for other dental instruments and handpieces, but does not directly treat a medical condition or disease.
No
The device description indicates it supplies power and services to other dental devices and accessories, and acts as a base for them. It does not perform any diagnostic functions itself or generate diagnostic information.
No
The device description clearly outlines numerous hardware components including units, arms, chairs, foot controls, junction boxes, lights, and monitors, in addition to providing air, water, vacuum, and electrical power. While it mentions software documentation, the core of the device is hardware-based.
Based on the provided information, the Pelton & Crane P50 series Dental Operative Units and Accessories are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to supply power and serve as a base for other dental devices and accessories by providing air, water, vacuum, and electrical power to dental instruments and handpieces. This is a functional support role for dental procedures performed directly on the patient.
- Device Description: The description details the components that deliver air, water, power, and vacuum, and how they connect to other dental instruments. It does not describe any components or processes that analyze samples taken from the human body (like blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on sample analysis.
- Using reagents or assays.
- Measuring biomarkers or other indicators in a sample.
The device is clearly designed to facilitate dental procedures performed in vivo (on the living patient) by providing the necessary utilities and support for the instruments used in those procedures.
N/A
Intended Use / Indications for Use
The Pelton & Crane P50 series Dental Operative Units and Accessories are intended to supply power to and serve as a base for other dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. The Pelton & Crane P50 series Dental Operative Units and Accessories are designed for use by a trained professional in the field of dentistry.
Product codes
EIA
Device Description
The P50 series Dental Operative Unit and Accessories serves as a base that includes components to deliver air, water, electrical power, and vacuum to dental handpieces, instruments, and accessories. The controls are contained in a Doctor's Unit, an Assistant's Unit, and a Cuspidor. Additional parts include mount arms, patient dental chair, foot control, and a junction box that houses a power supply and air/water requlators. The unit may also include a dental operating light and a monitor. Various handpieces, instruments, and accessories can be added to the P50 series Dental Operative Unit which Pelton & Crane does not manufacture but does provide a means to connect them to the P50 series Dental Operative Units. These include, but not limited to, pneumatic handpieces, electric motors with handpieces, scalers, intra-oral cameras, curing lights, air/water syringes, SE and HVE vacuum instruments. Water quality is maintained automatically by the preprogramed cleaning functions for the water lines, cuspidor spouts, and instrument hoses including motors and syringes. Instructions are provided for waterline treatment and suction cleaning agents. Water supply is available by either the municipal water supply or a self-contained water bottle.
The P50 series Dental Operative Units and Accessories are available in the following models in table 5.1 which are offered in various mounting configurations. The various mounting configurations for the P50 series Dental Operative Units and Accessories are illustrated within the use and care manuals.
Series: P50, Model: P50E, Description: Ellipse Mounted Delivery System
Series: P50, Model: P50P, Description: Post Mounted Unit (PMU) Delivery System
Series: P50, Model: P50S, Description: Side Mounted Delivery System
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
trained professional in the field of dentistry.
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
Non-Clinical Test Data: Performance bench testing according to international standards for dental operative units has been conducted to determine conformance in regards to: Biocompatibility has been completed for the applicable components. Software documentation for moderate level of concern per the FDA Guidance Document for Software Contained in Medical Devices. Comparative performance testing of the functions of the integrated accessories as compared to the cleared stand-a-lone device.
Clinical Performance Data: Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product.
Key results: The performance testing results provided in this submission supports that the proposed device performs as well as the predicate devices for its intended use.
Key Metrics
Not Found
Predicate Device(s)
ESTETICA (K161488)
Reference Device(s)
Spirit - (K143696), ELECTROmatic (K163317)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left, and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 26, 2018
Pelton & Crane Frank Ray Regulatory Affairs Manager 11727 Fruehauf Drive Charlotte, North Carolina 28273
Re: K171872
Trade/Device Name: P50 Series Dental Operative Unit and Accessories Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit And Accessories Regulatory Class: Class I Product Code: EIA Dated: March 26, 2018 Received: March 27, 2018
Dear Frank Ray:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K171872
Device Name
P50 series Dental Operative Units and Accessories
Indications for Use (Describe)
The Pelton & Crane P50 series Dental Operative Units and Accessories are intended to supply power to and serve as a base for other dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. The Pelton & Crane P50 series Dental Operative Units and Accessories are designed for use by a trained professional in the field of dentistry.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Pelton & Crane
Section V - 510(k) Summary for
P50 series Dental Operative Unit and Accessories
Submitter Information: 1.
Pelton & Crane 11727 Fruehauf Drive Charlotte, NC 28273
Frank Ray Contact Person: Telephone Number: (704) 587-7227 Fax Number: (704) 587-7250
Date Prepared: March 26, 2018
2. Device Name:
●
●
- Proprietary Name: P50 series ●
- Manufacturer: ●
Common Name:
Pelton & Crane
Dental Treatment Unit and Accessories
Classification Name: Unit, Operative Dental
- CFR Number: 872.6640
- Device Class: ●
- Product Code: EIA ●
3. Predicate Device:
- ESTETICA (K161488) Proprietary Name: ● Manufacturer: Kaltenbach & Voigt GMBH ● Common Name: Dental Treatment Unit and Accessories ● Classification Name: Unit, Operative Dental ●
- CFR Number: 872.6640 ●
I
- . Device Class: I
- Product Code: EIA .
Reference Device #1:
| o | Proprietary Name: | Spirit - (K143696) |
|---|---|---|
| o | Manufacturer: | Pelton & Crane |
| o | Common Name: | Dental Delivery Unit |
| o | Classification Name: | Unit, Operative Dental |
| o | CFR Number: | 872.6640 |
| o | Device Class: | I |
| o | Product Code: | EIA |
4
Reference Device #2:
- ELECTROmatic (K163317) Proprietary Name: o Manufacturer: Kaltenbach & Voigt GMBH o Common Name: Dental Handpiece and Accessories o Classification Name: Dental Handpiece and Accessories o CFR Number: 872.4200 o Device Class: I O Product Code: EBW o
4. Description of Device:
The P50 series Dental Operative Unit and Accessories serves as a base that includes components to deliver air, water, electrical power, and vacuum to dental handpieces, instruments, and accessories. The controls are contained in a Doctor's Unit, an Assistant's Unit, and a Cuspidor. Additional parts include mount arms, patient dental chair, foot control, and a junction box that houses a power supply and air/water requlators. The unit may also include a dental operating light and a monitor. Various handpieces, instruments, and accessories can be added to the P50 series Dental Operative Unit which Pelton & Crane does not manufacture but does provide a means to connect them to the P50 series Dental Operative Units. These include, but not limited to, pneumatic handpieces, electric motors with handpieces, scalers, intra-oral cameras, curing lights, air/water syringes, SE and HVE vacuum instruments. Water quality is maintained automatically by the preprogramed cleaning functions for the water lines, cuspidor spouts, and instrument hoses including motors and syringes. Instructions are provided for waterline treatment and suction cleaning agents. Water supply is available by either the municipal water supply or a self-contained water bottle.
Per the Guidance for Industry and FDA Staff; Bundling Multiple Devices or Multiple Indications in a Single Submission, dated June 22, 2007, Pelton & Crane is bundling the P50 series Dental Operative Unit and Accessories models listed below as the models do not differ significantly in purpose, design, materials, energy source, function or any other feature related to substantial equivalence. The device description and intended use are identical for all models listed below. The differences between the models and mounting configurations are cosmetic in nature such as mount arms, upholsteries, etc. All critical components within the P50 series Dental Operative Units and Accessories are common.
The P50 series Dental Operative Units and Accessories are available in the following models in table 5.1 which are offered in various mounting configurations. The various mounting configurations for the P50 series Dental Operative Units and Accessories are illustrated within the use and care manuals.
| Series | Model | Description |
|---|---|---|
| P50 | P50E | Ellipse Mounted Delivery System |
| P50 | P50P | Post Mounted Unit (PMU) Delivery System |
| P50 | P50S | Side Mounted Delivery System |
Table 5.1
The designation letters listed at the end of each model represents the style of delivery as identified below.
-
E = Ellipse Mounted: The dental unit is mounted to the dental chair and can swing/rotate to the left or right side of the dental chair for use.
-
P = Post Mounted: The dental unit is mounted to a utility center which is attached to the side of a dental chair.
5
-
S = Side Mounted: The dental unit is mounted to a cabinet or wall beside the dental chair.
Accessories:
Optional accessories (devices) that are integrated/attached to the P50 series Dental Operative Unit and Accessories have already been cleared by the FDA and have been tested as part of the P50 series Dental Operative Unit and Accessories Electrical and Safety / EMC (Section 17) and Performance Bench Testing (Section 18). Also, Pelton & Crane has quality system processes implemented for risk assessment for devices manufactured in compliance with ISO 14971:2007 as referenced in section 9 (Declarations of Conformity and Summary Reports). This includes the P50 series Dental Operative Unit and Accessories with attached/integrated Devices / Accessories listed below in Table 5.2. The Risk Management File was reviewed by our test house Intertek as part of obtaining 60601-1 certification.
As described in section 15 (Sterilization and Shelf Life), the optional devices that are integrated / attached to the P50 series Dental Operative Unit and Accessories may require sterilization and/or disinfection per their own manuals as they are provided non-sterile and are reusable. The sterilization/disinfection manuals for all Devices/Accessories listed in Table 5.2 below will be supplied with the P50 series Dental Operative Unit and Accessories.
Please note: The Quick Clean air/water syringe, Three-Function Handpiece (air/water syringe), Turbines, MULTIflex couplings, and SONICflex (ultrasonic scaler) listed in table 5.2 below are non-electrical devices.
| Device /
Accessory | Manufacturer | Product
Code | 510(k) Clearance | Integrated
/ Attached | Mechanism
of
Integration |
|-------------------------------------------------------------|----------------------------|-----------------|--------------------------------------------------------------------------------------------------|--------------------------|--------------------------------|
| INTRA LUX
KL 703 LED
(motor)* | Kaltenbach &
Voigt GmbH | EBW | FDA cleared under K103027 and
listed as a predicate Accessory in
K161488. | Attached | N/A |
| INTRA LUX
S600 LED
(motor) | Kaltenbach &
Voigt GmbH | EBW | FDA cleared under K140308 and
listed as a predicate Accessory in
K161488. | Attached | N/A |
| Quick Clean
air/water
syringe** | DCI
International | ECB | Class I, exempt under 21 CFR
872.4565 and listed as a Pelton &
Crane Accessory in K143696. | Attached | N/A |
| Three-
Function
Handpiece
(air/water
syringe)** | Kaltenbach &
Voigt GmbH | ECB | Class I, exempt under 21 CFR
872.4565 and listed as a
predicate Accessory in K161488. | Attached | N/A |
| Turbines | Kaltenbach &
Voigt GmbH | EFB | FDA cleared under K073478,
K130560 and listed as a
predicate Accessory in K161488. | Attached | N/A |
| Eletrical
handpieces | Kaltenbach &
Voigt GmbH | EFA
EFB | FDA cleared under K073478,
K143465 and listed as a
predicate Accessory in K161488. | Attached | N/A |
| MULTIFlex
couplings | Kaltenbach &
Voigt GmbH | EFB | FDA cleared under K073478,
K130560 and listed as a
predicate Accessory in K161488. | Attached | N/A |
| SONICflex
(ultrasonic
scaler) | Kaltenbach &
Voigt GmbH | ELC | FDA cleared under K080089 and
listed as a predicate Accessory in
K161488. | Attached | N/A |
Table 5.2
6
| Cavitron
G139
Scaler*** | DENTSPLY
International | ELC | FDA cleared under K052334 and
linked to Pelton & Crane
Accessory in K143696 | Integrated | Factory
installed
only |
|--------------------------------------------|--------------------------------------|-----|------------------------------------------------------------------------------------------------------|------------|------------------------------|
| PiezoLED
(electrical
scaler)**** | E.M.S. Electro
Medical
Systems | ELC | FDA cleared under K093000,
K132443, K140990 and listed as
a predicate Accessory in
K161488. | Integrated | Factory
installed
only |
| Satelec Mini
LED (curing
light) | Satelec | EBZ | FDA cleared under K032465,
K040808 and listed as a
predicate Accessory in K161488. | Attached | N/A |
| DIAGNOcam
2170
(Intraoral
Camera) | Kaltenbach &
Voigt GmbH | NTK | FDA cleared under K123402 and
listed as a predicate Accessory in
K161488. | Attached | N/A |
| Helios 3000
LED dental
light***** | Pelton & Crane | EAZ | Class I, exempt under 21 CFR
872.4630 | Attached | N/A |
| Helios 1800
LED dental
light***** | Pelton & Crane | EAZ | Class I, exempt under 21 CFR
872.4630 | Attached | N/A |
- Kaltenbach & Voit GmbH informed Pelton & Crane that their INTRA LUX KL 703 LED (motor) is linked to 510(k) number K103027 (Model KL 702) and they have quality system records to support this.
** The syringe is 510(k) exempt, patient contacting, and can be sterilized/disinfected per the Care Instructions.
*** DENTSPLY International informed Pelton & Crane that their Cavitron G139 Scaler is linked to 510(k) number
K052334 (Model G131) and it is their OEM Scaler Kit which is for integration into dental operative units and they have quality system records to support this.
*** E.M.S. Electro Medical Systems 510(k) K140990 is designed to integrate into a dental chair (dental unit).
**** Pelton & Crane Helios dental lights are made to attach to a dental chair. There are no patient contacting parts.
Principle of Operation / Mechanism of Action:
The P50 series Dental Operative Unit and Accessories is designed to bring a patient into an ergonomic and comfortable position to perform dental treatment procedures. For this purpose, the patient chair can be brought into an appropriate position, either by activating the chair positioning push buttons or by recalled programmed positions set by the user. The dental chairs double articulating headrest is manually adjusted for patient positioning by pushing the quick release button on the backside of the headrest as well as adjusting the height via the slide bar. The treatment is performed by the instruments placed in the designated instrument holders. The required parameters (e.g. power, torque, speed, cooling media) can be adjusted via a panel / touch panel or recalled from settings programmed by the user beforehand. After taking an instrument from its respective holder, it can be activated via the foot control. A tray is provided to place dental hand instruments and materials required during treatment.
The delivery head is mounted to an arm mechanism for support and positioning of the delivery head around the patient. The types of mounting configurations include a chair, utility, cabinet, or wall as illustrated within the Instructions for Use manual. A junction box or utility center provides housing for connections to the facility air, water, vacuum, and power sources, regulators for air and water, and solenoid valves for integrated accessories. Regulated air and water, source vacuum, and power tubing and cables are routed through the mounting arms to the delivery head where the utilities are distributed to the individual dental instruments with a handpiece control system contained in the delivery head.
To remove fluids and particles deriving from the oral cavity during treatment, suction hoses with attached instruments are provided on the assistant element. Selecting the suction instruments, the vacuum is activated by the Thumb Lever. A cuspidor bowl is available for patient rinse. Also, air and water syringes are not activated when removing from the instrument holder but rather
7
by the air/water requlators and the solenoid valve. Air and water flow is manually opened and closed with button actuated valves integrated into the syringe body.
An operating light providing illumination to the oral cavity can be switched on via the panel / touch screen or can be operated manually. Most chair and instrument related functions can be activated hands-free via foot control. The panel / touch screen style user interface applies context-sensitivity; i.e. according to the actual operational state, user-defined buttons and functions are displayed and provided for use. Prescribed procedures and supporting components apply to facilitate infection control and maintaining water quality, such as automated instrument hose purge. The automated purge opens all valves in the delivery head to run water and cleaning solution from the water bottle through all instrument lines for the duration specified by the program selected by the user. The program is activated with the touchscreen by the user. Instructions are also provided for waterline treatment and suction cleaning agents. Water supply is available by either the municipal water supply or a self-contained water bottle.
As an option the P50 series Dental Operative Unit and Accessories can be equipped with an endodontic and / or surgery function. The endodontic function has an electronic torque limitation with variable torque modes (auto reverse, auto reverse forward and torque control only). The surgery function has different program steps according to the implantation activities (pilot drilling, form drilling, tapping, placing implant, setting a closure cap, marking and free use).
Also a peristaltic pump and a NaCl bottle holder can be attached to the dentist element. The peristaltic pump prepares a sterile saline solution instead of spray water for cooling. This system connects as a "closed system" to the P50 series Dental Operative Unit and Accessories to ensure full sterility.
5. Indications for Use:
The Pelton & Crane P50 series Dental Operative Units and Accessories are intended to supply power to and serve as a base for other dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. The Pelton & Crane P50 series Dental Operative Units and Accessories are designed for use by a trained professional in the field of dentistry.
6. Description of Substantial Equivalence: Technological Characteristics:
The P50 series Dental Operative Units and Accessories function in a manner similar to and are intended for the same indications for use as the predicate device ESTETICA Dental Treatment Unit and Accessories (K161488) marketed by Kaltenbach & Voigt GmbH. There are numerous identical technological characteristics such as handpiece positions, quantity/type of electric motors, user interfaces, syringes, turbines, control of coolant, scalers, intraoral camera, curing lights, endodontic, USB interface with Dentist Element, suction, dental chairs with lift and recline, headrests, arm rests, footswitches, programable positions, water connections to municipal water or water bottle, cuspidor bowls, waterline treatment, automated instrument cleaning, water/suction hose treatment, purqe, foot controls, PC interface and LED dental lights, waterline treatment process and solution (KaVo OXYGENAL 6), automated instrument cleaning, purge function, preprogramed cleaning functions, daily cleaning process, weekly cleaning process, and a hygiene center.
However, there are different technological characteristics such as electrical power ranges as well as the predicate device has an optional multi-functional syringe with internal heater for water and light, x-ray viewer, curing light option and USB interface on assistant's unit, dental
8
chair lift capacity, armrest movement, traverse chair movement, adjustable cuspidor, amalgam separator, water unit heater and automated vs manual suction hose cleaning, monitor mount and optional wireless foot control. Furthermore, the proposed device offers a Cavitron Scaler option in addition to the PiezoLED with light and the SONICflex scalers options listed by both the proposed and predicate devices.
These different technological characteristics do not raise new concerns of substantial equivalence. The comparison table below (table 5.3) for the P50 series Dental Operative Units and Accessories (proposed device) and the ESTETICA Dental Treatment Unit and Accessories (predicate device) are substantially equivalent in terms of indication for use, technology and performance specifications as the few differences between the proposed device and the predicate device do not impact substantial equivalence. The performance testing results provided in this submission supports that the proposed device performs as well as the predicate devices for its intended use. Hence, the device is deemed to be substantially equivalent to the ESTETICA Dental Treatment Unit and Accessories (K161488).
Please note the two reference devices (Spirit - K143696 marketed by Pelton & Crane and ELECTROmatic - K163317 marketed by Kaltenbach and Voigt GmbH) are referenced in Biocompatibility section as they contain numerous identical patient contacting parts."
| Descriptive Information | Proposed Device
P50 series Dental Operative Unit
and Accessories | Predicate Device
ESTETICA Dental Treatment Unit and
Accessories |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use / Indications
for Use | The Pelton & Crane P50 series Dental
Operative Units and Accessories are
intended to supply power to and serve as
a base for other dental devices and
accessories by providing air, water,
vacuum and low voltage electrical power
to dental instruments and dental
handpieces. The Pelton & Crane P50
series Dental Operative Units and
Accessories are designed for use by a
trained professional in the field of
dentistry. | The ESTETICA Dental Treatment Unit and
Accessories are intended to supply power to and
serve as a base for other dental devices and
accessories by providing air, water, vacuum and
low voltage electrical power to dental
instruments and dental handpieces. The
ESTETICA Dental Treatment Unit and
Accessories are designed for use by a trained
professional in the field of general dentistry. |
| Regulation Number | 21 CFR 872.6640 | 21 CFR 872.6640 |
| Regulation Title | Dental operative unit and accessories | Dental operative unit and accessories |
| Regulation Class | I | I |
| Product Code | EIA | EIA |
| Power and Utility Supply | 115V/230V AC electrical supply,
compressed air and water | 100V/240V AC electrical supply,
compressed air and water |
| Protection Class | Class 1 Equipment | Class 1 Equipment |
| Applied Parts | Type B | Type B |
| Control of Air and Water | Uses pneumatically controlled valves to
Water control the flow of air and water.
On/off and intensity controlled by foot
pedal. | Uses pneumatically controlled valves to Water
control the flow of air and water. On/off and
intensity controlled by foot pedal. |
Table 5.3
9
| Dentist Element | Positions | 6 handpiece positions + 1 additional | 6 handpiece positions + 1 additional |
|---|---|---|---|
| Max. Motors | Up to 4 motors | ||
| (electrical motors with and without light) | Up to 4 motors | ||
| (electrical motors with and without light) | |||
| Electric Motors | INTRA LUX KL 703 LED | INTRA LUX KL 703 LED | |
| INTRA LUX S600 LED | INTRA LUX S600 LED | ||
| User Interface | EasyTouch Display, color | ESTETICA E70/E80 Vision: EasyTouch Display, | |
| color | |||
| ESTETICA E50 Life: Display, with several keys | |||
| (foil) and Status LED | |||
| Hands free operation via foot control | Hands free operation via foot controller. | ||
| Syringe | 3 Functional syringe without heater and | ||
| light or Quick Clean air/water syringe | Multifunctional syringe with internal heater for | ||
| water and light or 3 Functional syringe without | |||
| heater and light | |||
| Turbines | Turbines with light | Turbines with light | |
| MULTIflex couplings | MULTIflex couplings | ||
| Control of Coolant | Water pressure controlled by the unit | Water pressure controlled by the unit | |
| Air pressure controlled by the unit | Air pressure controlled by the unit | ||
| Scaler | PiezoLED with light | ||
| SONICflex | |||
| CAVITRON G139 | PiezoLED with light | ||
| SONICflex | |||
| Intraoral Camera | DIAGNOcam 2170 | DIAGNOcam 2170 | |
| Curing Light | Satelec Mini LED | Satelec Mini LED | |
| X-ray Viewer | N/A | Panorama X-ray image viewer or | |
| small X-ray viewer | |||
| Endodontic | Implantology functions | Implantology functions | |
| Endodontic treatment functions | Endodontic treatment functions | ||
| Adapted pump for saline solution | Adapted pump for saline solution | ||
| Interfaces | USB Interface | USB Interface | |
| Assistant Element | Positions | Up to 3 suction positions, | |
| 1 handpiece position (syringe) | 2/3 suction positions, | ||
| 2 handpiece positions (syringe and curing | |||
| light) | |||
| User Interface | Touch pad (foil) with several keys and | ||
| status LEDs | Touch pad (foil) with several keys and status | ||
| LEDs | |||
| Syringe | 3 Functional syringe without heater and | ||
| light or Quick Clean air/water syringe | Multifunctional syringe with internal heater for | ||
| water and light or 3 Functional syringe without | |||
| heater and light | |||
| Curing Light | Satelec Mini LED | Satelec Mini LED | |
| Suction | Suction devices | Suction devices | |
| Saliva ejector | Saliva ejector | ||
| HVE (High volume evacuator) | HVE (High volume evacuator) | ||
| Surgical suction devices | Surgical suction devices | ||
| Interfaces | No USB interface | USB interface | |
| Chair | Patient load | SP30 Chair - 450 lbs | |
| SP18 Chair - 350 lbs | |||
| SP17 Chair - 350 lbs | ESTETICA E70/E80 Vision: 396 lbs | ||
| ESTETICA E50 Life: 407 lbs (Standard Chair) | |||
| ESTETICA E50 Life: 297 lbs (Compact Chair) | |||
| Headrest | Manually operated | Manually operated or motorized headrest | |
| Upholstery | Naugasoft or Ultraleather upholstery | Skai upholstery | |
| Armrest | Armrest, retractable, rotate | Armrest, retractable | |
| User interface | Foot-switch and touchpad | Foot-switch | |
| Movement | Synchronized Backrest and seat | ||
| movements | Synchronized Backrest and seat movements | ||
| User programmable positions | User programmable positions | ||
| Backrest hydraulic driven | Backrest motor driven | ||
| N / A | ESTETICA E80 Vision: Horizontal movement, | ||
| seating bench lifting | |||
| Seat and seat inclination hydraulic | |||
| driven | Seat and seat inclination motor driven | ||
| Cuspidor bowl | Fixed bowl optional | Manually adjustable or Motor driven cuspidor | |
| bowl | |||
| Amalgam separator | N / A | Amalgam separator | |
| Water | Connection to municipal water or Self- | ||
| contained water bottle | Connection to municipal water with safety | ||
| separation via "air gap". Self-contained Water | |||
| bottle option for E50. | |||
| Heating | No heater | Water heater | |
| Water unit | Waterline Treatment solution | Waterline Treatment solution | |
| Water / Suction | |||
| Hose treatment | Automated instrument cleaning | Automated instrument cleaning | |
| Manual suction hose cleaning w/suction | |||
| line cleaner | Automated suction hose cleaning w/suction | ||
| line cleaner | |||
| Water treatment | Waterline Treatment solution | Waterline Treatment solution | |
| Purge | Purge function | Purge function | |
| Pre-programmed | |||
| waterline cleaning | |||
| functions | Automatic for water lines, cuspidor, | ||
| spouts, and instrument hoses including | |||
| motors and syringes | Automatic for water lines, cuspidor, spouts, | ||
| and instrument hoses including motors and | |||
| syringes | |||
| Daily Cleaning | Automated instrument flush with water | ||
| before start up and after down times. | |||
| Recommend 2 minutes per instrument | Automated instrument flush with water before | ||
| start up and after down times. Recommend 2 | |||
| minutes per instrument | |||
| Automatic after patient cleaning of | |||
| water and drainage system via fresh | |||
| water and cleaning solution if used. | |||
| Recommended 20 seconds | Automatic after patient cleaning of water and | ||
| drainage system via fresh water and cleaning | |||
| solution if used. Recommended 20 seconds | |||
| Weekly Cleaning | Automated flush with cleaning solution | Automated flush with cleaning solution | |
| Water Cleaner: KaVo OXYGENAL 6 | Water Cleaner: KaVo OXYGENAL 6 | ||
| Water Line | |||
| Treatment | Recommended 45 minutes cleaning time | ||
| to complete. | Recommended 45 minutes cleaning time to | ||
| complete. | |||
| Recommended | |||
| disinfectors | In accordance to EN ISO 15883-1 using | ||
| alkaline cleaning agents | In accordance to ISO 15883-1 using alkaline | ||
| cleaning agents | |||
| General | Hygiene Center | External holder for hoses and syringes | |
| during automated waterline cleaning | External holder for hoses and syringes during | ||
| automated waterline cleaning | |||
| Operating Light | Helios dental light 3000 - LED | ||
| Helios dental light 1800 - LED | LEDview - LED | ||
| Monitor | N / A | 19″ or 22″ monitor on the light support frame | |
| Foot Control | Standard DCI foot switch with chair foot control | Wireless Foot control available | |
| Electronic foot control | Electronic foot control | ||
| PC Interface | Yes | Yes |
10
11
Non-Clinical Test Data:
Performance bench testing according to international standards for dental operative units has been conducted to determine conformance in regards to:
- Biocompatibility has been completed for the applicable components. Please note, the two . reference devices (Spirit - K143696 marketed by Pelton & Crane and ELECTROmatic -K163317 marketed by Kaltenbach & Voigt GmbH) are referenced in Biocompatibility as they contain numerous identical patient contacting parts.
- . Software documentation for moderate level of concern per the FDA Guidance Document for Software Contained in Medical Devices.
- Comparative performance testing of the functions of the integrated accessories as . compared to the cleared stand-a-lone device.
Furthermore, the performance of the P50 series Dental Operative Unit and Accessories has been verified utilizing the following standards:
- AAMI ES60601-1:2005 +AC1; A2, Medical Electrical Equipment Part 1: General ● Requirements For Basic Safety And Essential Performance (R2012).
- . IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007), Medical Electrical Equipment -Part 1: General Requirements For Basic Safety And Essential Performance
- . IEC 60601-1-2 Edition 3: 2007-03, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- ISO 10993-1 Fourth edition 2009-10-15, biological evaluation of medical devices part . 1: evaluation and testing within a risk management process [including: technical corrigendum 1 (2010)].
- . ISO 7405 Second edition 2008-12-15 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (Including: Amendment 1 (2013)),
- . CAN/CSA-C22.2 No. 60601-1: 08(R2013) Issued: 2011/06/01 Medical Electrical Equipment - Part 1: General Req. for Basic Safety & Essential Perf.; Cor. 2: 2011
- . IEC 80601-2-60 Edition 1.0 2012-02, medical electrical equipment - part 2-60: particular requirements for the basic safety and essential performance of dental equipment
- IEC 62304 Edition 1.1 2015-06, medical device software software life cycle processes, ●
- . ISO 9168 Third edition 2009-07-15 Dentistry - Hose connectors for air driven dental handpieces.
- ISO 14457 First edition 2012-09-15 Dentistry Handpieces and motors. .
- ISO 7494-2 Second edition 2015-04-01, dentistry - dental units - part 2: air, water, suction and waste water system.
- . ISO 7494-1 Second edition 2011-08-15 - Dental units - Part 1: General requirements and test methods.
- . ISO 14971 Second Edition 2007-03-01, Medical Devices - Application of risk management to medical devices.
Hence the P50 series Dental Operative Unit and Accessories demonstrates substantial equivalence.
12
Clinical Performance Data:
Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product.
Conclusion as to Substantial Equivalence:
Based on a comparison of intended use, indications, technological characteristics, principle of operation, features and performance data, the P50 series Dental Operative Unit and Accessories are deemed to be substantially equivalent to the predicate device.