(269 days)
No
The device description and performance studies focus on basic utility provision (air, water, vacuum, power) and standard electrical/mechanical safety testing, with no mention of AI or ML.
No.
The document states that the device "serves as a base for ancillary dental devices and accessories by providing air, water, vacuum, and low voltage electrical power to hand-held dental instruments" and is intended for use by dental practitioners "to provide diagnostic treatment to dental patients." It facilitates diagnostic treatment but does not directly provide therapeutic treatment itself.
Yes.
The "Intended Use / Indications for Use" states that the device is "intended for use by dental practitioners to provide diagnostic treatment to dental patients in a clinical environment."
No
The device description clearly outlines physical components like controls, a utility center with a power supply and regulators, hoses, trays, and mounting assemblies, indicating it is a hardware device.
Based on the provided information, the Forest Dental Unit is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to serve as a base for ancillary dental devices and accessories by providing air, water, vacuum, and low voltage electrical power to hand-held dental instruments for diagnostic treatment of dental patients. This describes a device used in vivo (on a living patient) for treatment and diagnosis, not in vitro (outside the body) for examining specimens.
- Device Description: The description details the components and functions related to providing utilities to hand-held dental instruments used directly on the patient. There is no mention of analyzing biological specimens.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Reagents or assays
- Diagnostic tests performed on specimens
- Outputting results related to the analysis of specimens
The Forest Dental Unit is a piece of dental equipment that supports the use of other dental instruments. While those instruments might be used for diagnostic purposes on the patient, the unit itself is not performing an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Forest Dental Units are intended to serve as a base for ancillary dental devices and accessories by providing air, water, vacuum, and low voltage electrical power to hand-held dental instruments. The Forest Dental Units are intended for use by dental practitioners to provide diagnostic and therapeutic treatment to dental patients in a clinical environment.
Product codes
EIA
Device Description
The Forest Dental Unit serves as a base for ancillary dental devices and accessories by providing air, water, vacuum, and low voltage electrical power to hand-held dental instruments. The controls are contained in a Doctor's Unit, Assistant's Instrumentation Unit, Duo Unit (both Doctor's and Assistant's Control) and Cuspidor and are configured in a variety of mounts. Additional accessory items include a pneumatic unit foot control, utility center (aka junction box) that houses a power supply and air/water regulators, hoses, trays, and mounting assemblies. The dental unit is supplied air and water from the utility connections through air/water regulators via the umbilical chase. The dental unit is supplied SELV-24VAC from the output of the power supply, also routed through the umbilical chase and terminated on an internal terminal strip.
Various ancillary dental devices can be connected to the Forest Dental Unit which are attached by means of industry standard ISO connections. These ancillary devices include, but are not limited to, pneumatic handpieces, air/water syringes, SE and HVE vacuum instruments, electric micromotors, intra-oral cameras, scalers and curing lights. While Forest does not manufacture pneumatic or electric handpieces, scalers, intra-oral cameras or curing lights, it supplies ancillary devices in partnership with other manufacturers. These include Dentsply Cavitron Scaler (K150535), Satelec Ultasonic Scaler (K132267), and Bien-Air Electric Micromotor Handpiece (K042759). Other ancillary devices described above may be supplied to the end-user by authorized dental dealers.
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
dental practitioners, clinical environment
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)
Electrical, mechanical and general safety performance testing is according to standards of ANSI/AAMI ES60601-1 and the particular standard for dental equipment IEC 80601-2-60. Essential Performance, as defined by the standards and Forest Dental, were tested against pass/fail criteria. This evaluation under the 3rd Edition of the aforementioned general standard also demonstrated compliance with ISO 14971 for risk assessment and IEC 62366 for usability engineering. This system was also evaluated to the EMC standard, IEC 60601-1-2, ISO 7494-1 and ISO 7494-2 (including meeting all ISO requirements contained within 7494-1 and 7494-2). The reports from these evaluations demonstrate compliance to the requirements for medical devices. All tests passed assuring compliance to industry standards for dental equipment and assuring that the technological characteristic differences between the Forest Dental Operative Unit and the predicate device, the Pelton & Crane Spirit Dental Operative Units (K143696), do not represent any new concerns about substantial equivalence.
From the Clinical Evaluation Report - Dental Units, document # 98-0033a, on file at Forest Dental facility, we conclude the following:
- The overall technology used in the Forest Dental Operative Unit, is not novel, the intended use is common, and the Predicate Delivery Systems have been in use for a considerable length of time.
- The Forest Dental Operative Unit, configured as tested, does not introduce new risks to the user. The product risks are reasonably well understood.
- The Dental Unit meets the Forest defined Essential Performance requirements as tested.
- The Dental Unit meetings the Essential Requirements in Annex I of the Medical Devices Directive 93/42/EEC.
Biocompatibility evaluation was conducted in accordance with the FDA Guidance Document and ISO 10993-1 as recognized by the FDA. Cytotoxicity testing according to ISO 10993-5 was conducted on water and air line components and they were found to be non-cytotoxic. Dermal irritation testing has been completed by the manufacturer of the chair upholstery and the upholstery was found to be a non-irritant. Heavy metal analysis was also conducted to show that water line quality is compliant with EPA standards for drinking water.
Sterilization reports in accordance with ISO 17655-1:2006 for the air/water syringe tip, HVE and SE conclude that these reusable components can be sterilized to reach an acceptable sterility assurance level.
Cleaning and disinfection validation was conducted on clinical contact surfaces in accordance with the FDA Guidance Document on Reprocessing Medical Devices.
The Forest dental unit waterlines were validated according to ISO 16954:2015 to conclude that following the reprocessing directions in the instructions for use result in the waterlines being disinfected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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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 and 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" in blue, with the word "ADMINISTRATION" underneath.
August 17, 2018
Forest Dental Products, Inc. Erin-Kate Barton 6200 NE Cherry Drive Hillsboro, Oregon 97124
Re: K173608
Trade/Device Name: Forest Dental Unit Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit And Accessories Regulatory Class: Class I Product Code: EIA Dated: July 18, 2018 Received: July 20, 2018
Dear Erin-Kate Barton:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about medical devices and radiation-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
For 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
Indications for Use
510(k) Number (if known) K173608
Device Name Forst Dental Unit
Indications for Use (Describe)
The Forest Dental Units are intended to serve as a base for ancillary dental devices and accessories by providing air, water, vacuum, and low voltage electrical power to hand-held dental instruments. The Forest Dental Units are intended for use by dental practitioners to provide diagnostic treatment to dental patients in a clinical environment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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5.1 510(k) Summary
Traditional 510(k) Summary for Forest Dental Operative Unit and Accessories
5.1 Submitter
Forest Dental Products, Inc. 6200 NE Cherry Drive Hillsboro, OR 97124
| Contact Person: | Erin-Kate Barton |
|---|---|
| Telephone Number: | 971-327-9024 |
| Facsimile Number: | |
| E-mail address: | 503-693-9715 |
| ekbarton@forestdental.com | |
| Date Prepared: | July 18, 2018 |
5.2 Device Name
| Proprietary Name: | Forest Dental Unit |
|---|---|
| Common Name: | Dental Delivery Unit |
| Classification Name: | Dental Operative Unit and Accessories |
| CFR Number: | 872.6640 |
| Device Class: | I |
| Product Code: | EIA |
5.3 Primary Predicate Device
| Proprietary Name: | SPIRIT – K143696 |
|---|---|
| Common Name: | Dental Delivery Unit |
| Classification Name: | Dental Operative Unit and Accessories |
| CFR Number: | 872.6640 |
| Device Class: | I |
| Product Code: | EIA |
5.4 Device Description
The Forest Dental Unit serves as a base for ancillary dental devices and accessories by providing air, water, vacuum, and low voltage electrical power to hand-held dental instruments. The controls are contained in a Doctor's Unit, Assistant's Instrumentation Unit, Duo Unit (both Doctor's and Assistant's Control) and Cuspidor and are configured in a variety of mounts. Additional accessory items include a pneumatic unit foot control, utility center (aka junction box) that houses a power supply and air/water regulators, hoses, trays, and mounting assemblies. The dental unit is supplied air and water from the utility connections through air/water regulators via the umbilical chase. The dental unit is supplied
4
SELV-24VAC from the output of the power supply, also routed through the umbilical chase and terminated on an internal terminal strip.
Various ancillary dental devices can be connected to the Forest Dental Unit which are attached by means of industry standard ISO connections. These ancillary devices include, but are not limited to, pneumatic handpieces, air/water syringes, SE and HVE vacuum instruments, electric micromotors, intra-oral cameras, scalers and curing lights. While Forest does not manufacture pneumatic or electric handpieces, scalers, intra-oral cameras or curing lights, it supplies ancillary devices in partnership with other manufacturers. These include Dentsply Cavitron Scaler (K150535), Satelec Ultasonic Scaler (K132267), and Bien-Air Electric Micromotor Handpiece (K042759). Other ancillary devices described above may be supplied to the end-user by authorized dental dealers.
Per the Guidance for Industry and FDA Staff, Bundling Multiple Devices or Multiple Indications in a Single Submission, dated June 22, 2007, Forest is bundling the Forest Dental Unit models listed in Table 5.1 below. The models do not differ significantly in purpose (intended use), design, function, materials, energy source or any feature related to substantial equivalence. The device description and intended use are the same for all configurations of the models listed in Table 5.1.
The differences between the models in Table 5.1 include various mounting arms for positioning relative to the dental practitioner based on ergonomic preferences and do not influence device performance. The various models also represent differences in size/shape of the delivery head (aka control head) and pneumatic handpiece control block (pinch versus diaphragm style). The Forest models also provide various selling price points based on accessory features. All functional and critical components of the different configurations are common.
Dental Operative Units are an established, commoditized device type provided by numerous manufacturers. While specialty features exist (for example to offer greater portability or integration of ancillary controls), most dental operative units offer the same technology, connections, user interfaces and mounting options as provided by Forest Dental. Consequently, the Forest Dental operative units may be considered largely comparable or equivalent to most conventional systems that utilize cart, chair, wall or cabinet mounts and that provide a traditional, continental, pivot, or rear/side delivery style to the operator.
The different dental unit configurations are described in the Installation Guides and Operator's Guides (Instructions for Use) for each model. The table below identifies each model and description:
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| Model # | Description |
|---|---|
| 1095 | ASSISTANT'S INSTRUMENTATION W/INTERNAL UMBILICAL, REAR PIVOT |
| CHAIR MOUNT | |
| 1284 | ASSISTANT'S REAR BENEATH COUNTER SHELF MOUNT (CLEAN WATER, |
| WATER SHUT-OFF AND REGULATOR NOT INCLUDED) | |
| 1590 | DELUXE CUSPIDOR W/ASSISTANT'S INSTRUMENTATION & INTERNAL |
| UMBILICAL, REAR PIVOT CHAIR MOUNT | |
| 1637 | BASIC CUSPIDOR W/ASSISTANT'S INSTRUMENTATION & EXTERNAL |
| UMBILICAL, POST MOUNT | |
| 2184 | DUO UNIT, LEFT/RIGHT, VERTICAL MOUNT PANEL CONTROL (WORK |
| SURFACE NOT INCLUDED) | |
| 2400 | DR'S SIDE BENEATH COUNTER MOUNT STANDARD IC CONTROL HEAD |
| 2500 | DR'S PANEL MOUNT, COMPACT CONTROL, 3-HANDPIECE AUTOMATIC |
| 2520 | DR'S PANEL MOUNT, COMPACT CONTROL, 3-HANDPIECE AUTOMATIC |
| 3230 | DR'S SIDE WALL/VERTICAL MOUNT W/RIGID/FLEX ARM W/STANDARD IC |
| CONTROL HEAD | |
| 3235 | DR'S SIDE CABINET/VERTICAL MOUNT W/RIGID/FLEX ARM W/STANDARD IC |
| CONTROL HEAD | |
| 5350 | IC ECONOMY DOCTOR'S MOBILE CART |
| 5355 | IC ECONOMY DUO MOBILE CART |
| 5386 | ASSISTANT'S SWING/MOBILE CART W/VACUUM ARM, ASST'S |
| INSTRUMENTATION & LAMINATE WORK SURFACE | |
| 5886 | DUO SWING/MOBILE CART W/STANDARD IC CONTROL & LAMINATE WORK |
| SURFACE | |
| 1091INT-DURR | ASST'S INSTRUMENTATION, W/ DURR VACUUM, REAR |
| 1092INT-DURR | ASST'S INSTRUMENTATION, W/ DURR VACUUM, FIXED |
| 1095INT | ASST'S INSTRUMENTATION, REAR PIVOT MOUNT |
| 1286MCC | ASST'S INSTRUMENTATION, HORIZONTAL MOUNT W/LINK |
| 1400-412 | BDS-0050 REAR ASST'S SWING MOUNT, BEL-50 |
| 1500PI | REAR PIVOT MOUNT DUO UNIT W/INTERNAL UMBILICAL & STANDARD IC |
| CONTROL HEAD | |
| 1578INT-DURR | FIXED CHAIR MOUNT DELUXE CUSPIDOR W/DURR |
| 1637FE | BASIC CUSPIDOR W/ASSISTANT'S INSTRUMENTATION & EXTERNAL |
| UMBILICAL, POST MOUNT, W/WATER REGULATOR & MASTER SHUT-OFF | |
| 2001INT | HEAD ASSY, IC STANDARD W/FLEX ARM |
| 2002INT | HEAD ASSY, IC CONTOURED W/FLEX ARM |
| 2003INT | HEAD ASSY, EURO W/FLEX ARM |
| 2501MCC | COMPACT CONTROL, PANEL MOUNT, 3 HP, MCC |
| 2502MCC | COMPACT CONTROL, PANEL MOUNT, 3 HP, MCC |
| 2520MCC | COMPACT CONTROL, PANEL MOUNT, 2 HP AUTOMATIC |
| 2521MCC | COMPACT CONTROL, PANEL MOUNT, 2 HP AUTOMATIC |
| 2522MCC | COMPACT CONTROL, PANEL MOUNT, 2 HP AUTOMATIC |
| 3486BC | ASSISTANT'S REAR MOUNT BENEATH COUNTER SIDE DELIVERY |
| Table 5.1 Forest Dental Unit - Model Listing | |||||
|---|---|---|---|---|---|
| ---------------------------------------------- | -- | -- | -- | -- | -- |
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| Model # | Description |
|---|---|
| 3486UC | ASSISTANT'S REAR MOUNT UNDER CABINET SIDE DELIVERY W/LAMINATE TOP |
| 3486WM | ASSISTANT'S REAR WALL MOUNT SIDE DELIVERY W/LAMINATE TOP |
| 4001-225 | BDS-2561 LEFT RIGHT DUO UNIT, BELMONT |
| 4001-226 | BDS-2563 LEFT RIGHT ASSISTANTS UNIT, BELMONT |
| 4195FE | FIXED CHAIR MOUNT DR'S UNIT WITHOUT SIDEBOX W/EXTERNAL UMBILICAL & VALUE CONTROL HEAD |
| 4195PI | PIVOT CHAIR MOUNT DR'S UNIT W/INTERNAL UMBILICAL & VALUE CONTROL HEAD |
| 4195SE | FIXED CHAIR MOUNT DUO UNIT W/SIDEBOX, EXTERNAL UMBILICAL & VALUE CONTROL HEAD |
| 4195SI | FIXED CHAIR MOUNT DUO UNIT W/SIDEBOX, INTERNAL UMBILICAL & VALUE CONTROL HEAD |
| 4485FE | FIXED CHAIR MOUNT DR'S UNIT WITHOUT SIDEBOX W/EXTERNAL UMBILICAL & STANDARD IC CONTROL HEAD |
| 4485PI | PIVOT CHAIR MOUNT DR'S UNIT W/INTERNAL UMBILICAL & STANDARD IC CONTROL HEAD |
| 4485SE | FIXED CHAIR MOUNT DUO UNIT W/SIDEBOX, EXTERNAL UMBILICAL & STANDARD IC CONTROL HEAD |
| 4485SI | FIXED CHAIR MOUNT DUO UNIT W/SIDEBOX, INTERNAL UMBILICAL & STANDARD IC CONTROL HEAD |
| 4987FE | FIXED CHAIR MOUNT DR'S UNIT WITHOUT SIDEBOX W/EXTERNAL UMBILCAL & EURO CONTROL HEAD |
| 4987PI | PIVOT CHAIR MOUNT DR'S UNIT W/INTERNAL UMBILICAL & EURO CONTROL HEAD |
| 4987SE | FIXED CHAIR MOUNT DUO UNIT W/SIDEBOX, EXTERNAL UMBILICAL & EURO CONTROL HEAD |
| 4987SI | FIXED CHAIR MOUNT DUO UNIT W/SIDEBOX, INTERNAL UMBILICAL & EURO CONTROL HEAD |
| 7000INT | DUO SWING DELIVERY SYSTEM 7000 |
| 7000INT-DURR | DUO SWING DELIVERY SYSTEM 7000 W/ DURR VACUUM |
| 7010BC | DUO SYSTEM, REAR MOUNT, BENEATH COUNTER SIDE DELIVERY W/SOLID SURFACE TOP |
| 7010MC | DUO MOBILE CART W/ SOLID SURFACE TOP |
| 7010UC | DUO SYSTEM, REAR MOUNT, UNDER CABINET FLOOR MOUNT SIDE DELIVERY W/SOLID SURFACE TOP |
| 7010WM | DUO SYSTEM, REAR MOUNT, WALL MOUNT SIDE DELIVERY W/SOLID SURFACE TOP |
| 7020PRO-BC | DUO DELIVERY PRO 7000 SERIES, BENEATH COUNTER |
| 7020PRO-MC | DUO DELIVERY PRO 7000 SERIES, MOBILE CART |
| 7020PRO-UC | DUO DELIVERY PRO 7000 SERIES, UNDER CABINET FLOOR MOUNT |
| 7020PRO-WM | DUO DELIVERY PRO 7000 SERIES, WALL MOUNT |
| 7021PRO-BC | DUO DELIVERY PRO BASE MODEL, 7000 SERIES, BENEATH COUNTER |
| 7021PRO-MC | DUO DELIVERY PRO BASE MODEL, 7000 SERIES, MOBILE CART |
| 7021PRO-UC | DUO DELIVERY PRO BASE MODEL, 7000 SERIES, UNDER CABINET FLOOR MOUNT |
| 7021PRO-WM | DUO DELIVERY PRO BASE MODEL, 7000 SERIES, WALL MOUNT |
| Model # | Description |
| 7022PRO-BC | ASST'S DELIVERY PRO 7000 SERIES, BENEATH COUNTER |
| 7022PRO-MC | ASST'S DELIVERY PRO 7000 SERIES, MOBILE CART |
| 7022PRO-UC | ASST'S DELIVERY PRO 7000 SERIES, UNDER CABINET FLOOR MOUNT |
| 7022PRO-WM | ASST'S DELIVERY PRO 7000 SERIES, WALL MOUNT |
| 7023PRO-BC | ASST'S DELIVERY PRO BASE MODEL, 7000 SERIES, BENEATH COUNTER |
| 7023PRO-MC | ASST'S DELIVERY PRO BASE MODEL, 7000 SERIES, MOBILE CART |
| 7023PRO-UC | ASST'S DELIVERY PRO BASE MODEL, 7000 SERIES, UNDER CABINET FLOOR |
| MOUNT | |
| 7023PRO-WM | ASST'S DELIVERY PRO BASE MODEL, 7000 SERIES, WALL MOUNT |
| MT600BS | DR'S BENEATH SHELF MOUNT, MT COMPACT CONTROL, 3-HANDPIECE |
| AUTOMATIC | |
| MT600TS | DR'S TOP SHELF MOUNT, MT COMPACT CONTROL, 3-HANDPIECE |
| AUTOMATIC | |
| MT610BS | DR'S BENEATH SHELF MOUNT, MT COMPACT CONTROL, 2-HANDPIECE |
| AUTOMATIC | |
| MT610TS | DR'S TOP SHELF MOUNT, MT COMPACT CONTROL, 2-HANDPIECE |
| AUTOMATIC |
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Principle of Operation:
The dental unit (delivery system, control head) is mounted to an articulated arm mechanism for support and positioning of the dental unit relative to the patient's head. The types of mounting configurations include chair, cabinet, wall, and cart as described in the product labeling. The mounting configuration determines the location of the utility center which provides the housing and necessary connections for pressurized air, vacuum, water and electrical power. Tubing and electrical cables are routed through the umbilical assembly located in the mounting arm of the dental unit and make the connection from the control head to the utilities, or the source of requlated air, water and vacuum source. These utilities are distributed to the individual ancillary devices by the pneumatic system located within the control head.
The pneumatic system that powers the handpiece distributes air and water to the individual devices once they are selected, i.e. removed from their respective holder. Once an individual device is activated, the control block prevents any other handpiece device from becoming active (lock-out). Only one handpiece device can be active at any given time, once a device is returned to the holder it is no longer active. The foot control operates the handpiece using drive air and activates coolant air and water. Individual handpiece drive air and water flow adjustments are controlled by the operator via external control valve knobs attached to the internal control block. For handpieces with pneumatically activated internal lighting capability, the time delay of the output light can be
40
8
adjusted after the foot control is released. The control head has a master on-off switch that shuts on/off air and water to the dental unit.
Suction instruments, High-Volume Extractor(HVE) and Saliva Ejector(SE) ancillary devices, are not activated by or operated with the handpiece pneumatic system but each have their own manual valve for activation. These devices operate independently, as part of the vacuum system; they can be used at the same time as a handpiece and air/water syringe.
The air/water dental syringe is also not activated with the handpiece pneumatic system but is manually activated by depressing the water and air button actuated valves on the syringe body. The syringe can be used at the same time as a handpiece and suction instruments. This device operates by delivering air and water through the syringe body and tip into the oral cavity.
Electrically powered ancillary devices can be configured with the dental unit. These include but are not limited to Dentsply Cavitron Scaler (K150535), Satelec Ultasonic Scaler (K132267), and BienAir Electric Micromotor Handpiece (K042759). When configured with one or more of these devices, the ancillary control module is located either in the unit control head or attached underneath the unit control head as described by the ancillary device manufacturer's installation instructions. The SELV-24VAC is supplied to the ancillary control module(s) and the associated handpiece is located on one of the handpiece control holders. Air and water are supplied and routed through the proprietary tubing assembly for the device. The handpieces for these electrically powered ancillary devices are activated by the control block identical to the pneumatic handpieces for active operation lock-out and the handpiece drive air provides a signal for activation of the electric power for operation of the handpiece.
5.5 Indications for Use:
The Forest Dental Units are intended to serve as a base for ancillary dental devices and accessories by providing air, water, vacuum, and low voltage electrical power to hand-held dental instruments. The Forest Dental Units are intended for use by dental practitioners to provide diagnostic and therapeutic treatment to dental patients in a clinical environment.
5.6 Description of Substantial Equivalence
We chose the Pelton & Crane dental operative unit (K143696) to be the primary predicate device. Table 5.2 provides a visual and tabular comparison between the Forest Dental unit and predicate unit by Pelton & Crane.
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To demonstrate substantial equivalence, three types of comparative analyses were performed:
- . Detailed predicate device comparisons on electrical, mechanical and environmental specifications. Comparison of key features and functions.
- Clinical Performance Data ●
- . Non-Clinical Performance Data
5.6.1 Technological Characteristics
The Forest Dental Operative Units have the same intended use as previously cleared Spirit Dental Operative Units (K143696) manufactured by Pelton & Crane. Both are compatible with multiple accessory attachments such as optional trays, surfaces, and gravity drain cuspidors and may be installed using a variety of mounting options including direct attachment to the chair. While there are some different technological characteristics of the Spirit (See Table 5.2), these differences do not raise new concerns of substantial equivalence as compared to the predicate device. The performance data and testing of the Forest Dental Units demonstrates that the unit is as substantial in equivalence to the Pelton & Crane Spirit Dental Operative Unit.
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| Table | 5.2 |
|---|---|
| ------- | ----- |
Description of Substantial Equivalence-Comparison Table
| Comparison
Parameter | Primary Predicate Device
Pelton & Crane Spirit 1500
OTP w/Traditional Delivery
Dental Operative Unit
(K143696) | Forest Dental Operative Unit
and Accessories, 4485SI |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Image: Pelton & Crane Spirit 1500 OTP w/Traditional Delivery Dental Operative Unit (K143696) | Image: Forest Dental Operative Unit and Accessories, 4485SI |
| Indications for Use | The Spirit Dental Operative Units
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 hand
held dental instruments. The Spirit
Dental Operative Units are intended
for use by professional dental
practitioners in providing treatment
to dental patients in a dental
operatory. | The Forest Dental Units are
intended to serve as a base for
ancillary dental devices and
accessories by providing air, water,
vacuum, and low voltage electrical
power to hand-held dental
instruments. The Forest Dental
Units are intended for use by
dental practitioners to provide
diagnostic and therapeutic
treatment to dental patients in a
clinical environment. |
| Regulation Number | 21 CFR 872.6640 | Same as Primary Predicate
Device |
| Regulation Title | Dental operative unit and
accessories | Same as Primary Predicate
Device |
| Regulation Class | I | Same as Primary Predicate
Device |
| Product Code | EIA | Same as Primary Predicate
Device |
| Device
Classifications
(Electrical) | Class I, Type B applied part,
IPX0, continuous operation | Same as Primary Predicate
Device |
| | Utilities and Standards | |
| Transportation /
Storage
temperature | -68°F to 122°F | -20°F to 140°F 1 |
| Relative humidity
range | 10% to 90% | 25% to 90% 1 |
| Operating
temperature range | 68°F to 76°F | Same as Primary Predicate
Device |
| Comparison
Parameter | Primary Predicate Device
Pelton & Crane Spirit 1500
OTP w/Traditional Delivery
Dental Operative Unit
(K143696) | Forest Dental Operative Unit
and Accessories, 4485SI |
| Air supply
pressure range | 80-105 psi | Same as Primary Predicate
Device |
| Air/oil separator | Gauze pad | Same as Primary Predicate
Device |
| Water supply pressure
range | 40-80 psi | Same as Primary Predicate
Device |
| Isolated water
bottle system | Optional | Standard Feature 6 |
| Standards | EN 60601-1-2:2007 Part 1-2 EN
61000-3-2:2006+A1:2009
+A2:2009 Part 3-2
ES 60601 -1 Part 1
ISO 7494-1:2004
ISO 7494-2:2003 | Same as Primary Predicate
Device, plus IEC 80601-2-60 8 |
| User / Service Interface | | |
| Number of user accounts | One | N/A 5 |
| Setting display | LCD screen | N/A 5 |
| Screen navigation | Navigation arrows | N/A 5 |
| Software updates | Via internal 10-pin port | N/A 5 |
| Error tracking | Available | N/A 5 |
| Built-in diagnostics | Available | N/A 5 |
| Hand Held Devices | | |
| Optional ancillary devices | Air/water syringe
Saliva ejector
HVE
Up to 2 micro motors
Scaler
Camera
Curing light
Pneumatic motor | Air/water syringe
Saliva ejector
HVE
Up to 2 micro motors 7
Scaler 7
Intra-oral Camera 7
Curing light 7
Pneumatic motor 7 |
| Ancillary connections | Mechanically attached and supplied utilities | Same as Primary Predicate Device 5,7 |
| Number of hand piece locations | 4-6 | 4-5 2 |
| Hand piece control system | Valve block | Same as Primary Predicate Device |
| Syringe water flow control | Adjustable | Optional 2 |
| Syringe air flow control | Adjustable | Optional 2 |
| Coolant air flow control | Adjustable | Same |
| Hand piece air and water bypass | Handpiece air and water bypass is not necessary for the Primary Predicate both air and water are pneumatically controlled rather than electronically controlled. | Same as Primary Predicate Device |
| Number of hand piece presets | Six | N/A 5 |
| Remote hand piece activation with water toggle | Via foot control | Same as Primary Predicate Device |
| Positioning | | |
| Delivery unit head positioning | Flex arm | Same as Primary Predicate Device |
| Flex arm brake release | Mechanically Integrated | Same as Primary Predicate
Device |
| Maximum load on
flex arm mounted
units | 10 lbs 4 | 10 lbs 2,4 |
| Panel Mount | Not offered with Primary Predicate | Dental Unit control head mounted
to a dental furniture vertical face. 2 |
| Additional Features | | |
| Endodontic capability | Offered | Same as Primary Predicate
Device |
| Hand piece flush | Standard feature | Same as Primary Predicate
Device |
| Air/Water
quick
connect ports | Offered | Same as Primary Predicate
Device |
| Light control | Offered | Not offered 2 |
| Tray options | One | Same as Primary Predicate
Device |
| Unit configurations for
dominant hand | Left/Right | Same as Primary Predicate
Device |
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1 Forest storage temperature evaluated per ISTA Table 3A, Extreme Cold, Uncontrolled RH and Hot, Humid, then Extreme Heat and Moderate RH. These differences do not affect substantial equivalence as the testing parameters chosen are reasonable and adequate for normal use and transportation conditions.
2 These differences do not affect substantial equivalence as they are only differences in marketing features between the proposed device and the predicate device.
4 In the Spirit Dental Operative Unit manuals, it states: "The maximum weight capacity for the control head is 3lbs." However, this only notes the limit of additional weight that can be placed on the control head. When considering the load of the control head itself and included accessories, the maximum load on the flex arm is 10lbs. Forest Dental maximum capacity for the flex arm is 4.5lbs. which is in addition to the weight of the control head.
5 User Service/Interface Features: Number of User Accounts, Setting Display, Screen Navigation, Software Updates, Error Tracking and Built-in Diagnostics. The predicate Spirit dental unit has an integrated LCD panel for control of ancillary devices (i.e. ELECTROtorque TLC, COMFORTronic/COMFORTdrive Handpiece). The Forest system utilizes the display panel/control touchpad provided by the ancillary device manufacturer which is installed on the Forest dental unit's control head holder bar instead of being built-in to the control head. The display panel/control touchpad from the device manufacturer provides the functionality for the number of accounts, setting display, and screen navigation; software updates, error tracking and built-in diagnostics are also controlled by the software of the ancillary device manufacturer. Both the predicate device and Forest dental units are not software controlled. This provides equivalent performance and there are no safety issues introduced between the two types of display/control touchpad setups.
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6 Isolated Water Bottle System: Forest considers this feature as a necessary and essential item to include in all standard configurations. This improves the patient safety of our system over the predicate device by providing known quality water for use in general dental procedures.
7 Optional Accessories: Pneumatic handpieces, electric micromotors, cameras, scalers and curing lights are not manufactured by Forest Dental and are installed by the end-user (qualified service technician on behalf of the customer) using the same installation method used by Primary Predicate device manufacturer. As an added service, Forest will configure a Bien-Air micromotor, Satelec scaler or Cavitron scaler into the dental unit. The Primary Predicate offers the same service but with different ancillary brands.
8 Standards Compliance: Performance and safety standards applied specifically to the Forest Dental operative unit include:
EN 60601-1-2:2007 Part 1-2
EN 61000-3-2:2006+A1:2009 +A2:2009 Part 3-2
ISO 7494-1 Second edition 2011-08-15 Dentistry - Dental units - Part 1: General requirements and test methods
ISO 7494-2 Second edition 2015-04-01 Dentistry - Dental units - Part 2: Air, water, suction and waste water
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 ISO 7494-1, ISO 7494-2, and IEC 80601
Forest tested our unit against the same standards as Pelton & Crane Spirit Operative unit. We added IEC 80601-2-60 and tested our conformance to this standard. All tests passed. Although this standard defines the particular requirements for the basic safety and essential performance of dental equipment, compliance with basic safety IEC 60601-1, this particular standard, and essential performance as defined in Forest Dental memo on defining essential performance, assures that we meet our ESSENTIAL PERFORMANCE and safety standards during the intended use of the unit.
5.6.2 Clinical Performance Data:
Electrical, mechanical and general safety performance testing is according to standards of ANSI/AAMI ES60601-1 and the particular standard for dental equipment IEC 80601-2-60. Essential Performance, as defined by the standards and Forest Dental, were tested against pass/fail criteria. This evaluation under the 3rd Edition of the aforementioned general standard also demonstrated compliance with ISO 14971 for risk assessment and IEC 62366 for usability engineering. This system was also evaluated to the EMC standard, IEC 60601-1-2, ISO 7494-1 and ISO 7494-2 (including meeting all ISO requirements contained within 7494-1 and 7494-2). The reports from these evaluations demonstrate compliance to the requirements for medical devices. All tests passed assuring compliance to industry standards for dental equipment and assuring that the technological characteristic differences between the Forest Dental Operative Unit and the predicate device, the Pelton & Crane Spirit Dental
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Operative Units (K143696), do not represent any new concerns about substantial equivalence.
From the Clinical Evaluation Report - Dental Units, document # 98-0033a, on file at Forest Dental facility, we conclude the following:
- . The overall technology used in the Forest Dental Operative Unit, is not novel, the intended use is common, and the Predicate Delivery Systems have been in use for a considerable length of time.
- . The Forest Dental Operative Unit, configured as tested, does not introduce new risks to the user. The product risks are reasonably wellunderstood.
- The Dental Unit meets the Forest defined Essential Performance ● requirements as tested.
- The Dental Unit meetings the Essential Requirements in Annex I of the . Medical Devices Directive 93/42/EEC.
5.6.3 Non-Clinical Performance Data:
Test reports are available for the following:
Biocompatibility evaluation was conducted in accordance with the FDA Guidance Document and ISO 10993-1 as recognized by the FDA. Cytotoxicity testing according to ISO 10993-5 was conducted on water and air line components and they were found to be non-cytotoxic. Dermal irritation testing has been completed by the manufacturer of the chair upholstery and the upholstery was found to be a non-irritant. Heavy metal analysis was also conducted to show that water line quality is compliant with EPA standards for drinking water.
Sterilization reports in accordance with ISO 17655-1:2006 for the air/water syringe tip, HVE and SE conclude that these reusable components can be sterilized to reach an acceptable sterility assurance level.
Cleaning and disinfection validation was conducted on clinical contact surfaces in accordance with the FDA Guidance Document on Reprocessing Medical Devices.
The Forest dental unit waterlines were validated according to ISO 16954:2015 to conclude that following the reprocessing directions in the instructions for use result in the waterlines being disinfected.
5.6.4 Conclusion as to Substantial Equivalence:
Based on the comparison of intended use, technological characteristics, and performance data, the Forest Dental Operative Unit is substantially equivalent to 5-14
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Section 5 - 510(k) Summary
the predicate device, Pelton & Crane Spirit Dental Operative Unit. Forest Dental Products, Inc. concludes that the Forest Dental Units are substantially equivalent to the predicate device.