(4 days)
Not Found
No
The 510(k) summary describes a standard dental operative unit with components like a chair, utility center, and power supply for instruments. There is no mention of AI, ML, image processing, or any data-driven algorithms in the intended use, device description, or performance studies.
No
The device primarily serves as a base and power supply for other dental instruments used in treatment, rather than directly providing therapy itself. It positions the patient and powers tools, but doesn't independently perform therapeutic actions.
No
The device is described as an operative unit that supplies power and serves as a base for dental devices. Its purpose is to position the patient and provide power to the dentist's instruments, not to diagnose medical conditions.
No
The device description explicitly lists hardware components such as a patient chair, dentist's element, utility center, floor box, cuspidor, assistant's element, and dental operating light. The performance studies also focus on bench testing of the physical device against electrical safety and other hardware-related standards.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "supply power and serve as a base for dental devices and accessories" and for "treatment of dental patients in the dental clinic/office environment." This describes a piece of equipment used during a dental procedure, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a dental operating system including a patient chair, dentist's element, utility center, etc. These are all components of a physical setup for performing dental work, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Flight Dental Systems A-Series Operative Units do not fit this description.
N/A
Intended Use / Indications for Use
The Flight Dental Systems A-Series Operative Units are intended to supply power and serve as a base for dental devices and accessories. The use intended is in the treatment of dental patients in the dental clinic/office environment. The units are for use only by trained dentists, dental hygienists, dental technicians and dental assistants.
Product codes
EIA
Device Description
The Flight A-Series Dental Operative Unit is a dental operating system. The device includes a patient chair, dentist's element, utility center and a floor box. The unit may also include a cuspidor, an assistant's element and a dental operating light. The doctor's element may be mounted on the patient chair or on a mobile cart.
The unit is used to position the patient in a comfortable position and to provide the power to the dentist's instruments including dental handpieces.
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 patients in the dental clinic/office environment. The units are for use only by trained dentists, dental hygienists, dental technicians and dental assistants.
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
Bench testing has been performed on a sample that is in all respects the same as the device to be marketed. Testing was performed against local GB standards in China including GB9706.1-1995 and Y Y/T1043-2004 which are near equivalent to the recognized consensus standards ISO 7494-2:2003 and ISO 7494-1:1996. In any case in which the local standard was not equivalent to the recognized Consensus standard, additional testing has been performed in accordance with the recognized consensus standards.
Further independent laboratory testing was performed by Intertek Testing of Mississauga, Ontario Canada to confirm conformity UI. 60601-1 and CAN/CSA-C22.2 No. 601.58aagage, with the electrical safety portions of ISO 7494-1:1996. In any case in which the local standard was not equivalent to the recognized Consensus standard, additional testing has been performed in accordance with the recognized consensus standard.
The equipment has also been tested against ISO 9168:1991, and found to be in compliance with the standard. The patient and operator contact surfaces have been tested and found to be in compliance with ISO 7405:1997. The device is composed of materials that have a long instory of use in the medical and dental community.
No deviations from the recognized standards were found except those noted in the table provided in section 9 of this submission. In any case of deviation from the recognized standard alternate methods of meeting safety and effectiveness requirements were implemented.
The conclusions drawn from the bench testing are that the device is as safe and as effective as the predicate device. Furthermore, the device performs its intended tasks as well as the legally marketed predicate device and complies with the recognized standards.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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510(K) SUMMARY 5.0
The 510(k) Summary follows.
510(k) SUMMARY
JAN 26 2007
Manufacturer's Name, Contact Person, Address, Phone, Fax, Email, Date Prepared
| Mfr Name: | HR Dental Products Inc. |
|---|---|
| Contact Name: | Jim Ronalds |
| Postal Address. | 21 Kenview Blvd, Unit 9 |
| Brampton, ON Canada | |
| L6T 5G7 | |
| Phone: | 905-799-0517 |
| Fax: | 905-793-2406 |
| Email: | jimronalds@rogers.com |
Date Prepared: September 14, 2006, 2006
Device Name, Common/Generic Name and Classification Name
Flight Dental Systems A-Series Dental Operative Unit Proprietary Name:
Common/Usual Name: Dental operative unit
Classification Name / Code: Unit, Operative Dental / ElA
Predicate Device
Sirona C8+ Dental Operative unit - K983242
Description of the Device
The Flight A-Series Dental Operative Unit is a dental operating system. The device includes a patient chair, dentist's element, utility center and a floor box. The unit may also include a cuspidor, an assistant's element and a dental operating light. The doctor's element may be mounted on the patient chair or on a mobile cart.
The unit is used to position the patient in a comfortable position and to provide the power to the dentist's instruments including dental handpieces.
Intended Use of the Device
The Flight Dental Systems A-Series Operative Units are intended to supply power and serve as a base for dental devices and accessories. The use intended is in the treatment of dental patients in
Traditional 510(k) Submission
1
the dental clinic/office environment. The units are for use only by trained dentists, dental hygienists, dental technicians and dental assistants.
Technological Characteristics
The general components, design, characteristics and mode of operation of the Flight A-Series Dental Operative Unit is substantially equivalent to Sirona C8 Dental Operative Unit. Both are AC powered operative units with accessories that are intended to supply power to and serve as a base for dental devices and accessories. Both systems include the doctor's element, patient chair, floor box and utility center and may include optional cuspidors, operating lights and assistants elements.
Performance Data
Bench testing has been performed on a sample that is in all respects the same as the device to be marketed. Testing was performed against local GB standards in China including GB9706.1-1995 and Y Y/T1043-2004 which are near equivalent to the recognized consensus standards ISO 7494-2:2003 and ISO 7494-1:1996. In any case in which the local standard was not equivalent to the recognized Consensus standard, additional testing has been performed in accordance with the recognized consensus standards.
Further independent laboratory testing was performed by Intertek Testing of Mississauga, Ontario Canada to confirm conformity UI. 60601-1 and CAN/CSA-C22.2 No. 601.58aagage, with the electrical safety portions of ISO 7494-1:1996. In any case in which the local standard was not equivalent to the recognized Consensus standard, additional testing has been performed in accordance with the recognized consensus standard.
The equipment has also been tested against ISO 9168:1991, and found to be in compliance with the standard. The patient and operator contact surfaces have been tested and found to be in compliance with ISO 7405:1997. The device is composed of materials that have a long instory of use in the medical and dental community.
No deviations from the recognized standards were found except those noted in the table provided in section 9 of this submission. In any case of deviation from the recognized standard alternate methods of meeting safety and effectiveness requirements were implemented.
The conclusions drawn from the bench testing are that the device is as safe and as effective as the predicate device. Furthermore, the device performs its intended tasks as well as the legally marketed predicate device and complies with the recognized standards.
Substantial Equivalence Conclusions
In all important respects the Flight dental Systems A-Series Dental Operative Units are substantially equivalent to the Sirona Dental Systems C8 (K983242). This conclusion is ased upon indications for use, technical characteristics, device users and features comparison. Any
2
differences in the technological characteristics do not raise any new safety and effectiveness issues.
| Characteristic | Sirona C8 - K983242 | Flight Dental Systems A-Series |
|---|---|---|
| Intended Use | The Sirona C8 is an electronically | |
| controlled dental operative unit with | ||
| accessories that are intended to supply | ||
| power to and serve as a base for dental | ||
| devices and accessories | Equivalent | |
| Control of Air and | ||
| Water | Uses pneumatically controlled vales to | |
| control the flow of air and water. On/off | ||
| and intensity controlled by foot pedal | Equivalent | |
| Installation | Available with chair mounted and cart | |
| mounted dentist element. Installed by | ||
| trained technicians. | Equivalent. | |
| Components | Doctors element, assistant's element, | |
| flex arm, utility center with optional | ||
| cuspidor, patient chair, treatment light, | ||
| floor box. | Equivalent | |
| Optional accessories | Cuspidor, Assistant element with vaccum | |
| valves, treatment light, foot switches, | ||
| monitor mounts | Equivalent | |
| Power and Utility | ||
| Supply | 110V/220V AC electrical supply, | |
| compressed air and water | Equivalent | |
| Compatibility | Compatible with industry standard fittings | |
| for Air/water syringe tips, high speed and | ||
| low speed pneumatic turbines, air scaler, | ||
| air polisher, High Volume Evacuator tips. | ||
| Use industry standard 4-Hole handpiece | ||
| tubings. | Equivalent | |
| Electrical Safety | ||
| Standards | Not Specified | UL 60601-1 |
| CAN/CSA-C22.2 No. 601.1 M90 | ||
| See Appendix H | ||
| Water System | User may select Self Contained water | |
| system or city water supply | Equivalent | |
| Cleaning System | Water Flush | Equivalent -- See Appendix E |
| Activation | Master on/off, toggle switch and foot | |
| control | Equivalent | |
| Place of Use | Dental office, hospital | Equivalent |
| Intended Users | Dentists, Dental Hygienists, Dental | |
| Assistants | Equivalent |
Traditional 510(k) Submission
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings or feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 6 2007
HR Dental Products, Incorporated C/O Mr. Neil E. Devine Responsible Third Party Official Intertek Testing Services NA. Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
Re: K070196
Trade/Device Name: Flight Dental Systems A-Series Dental Operative Units Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: January 19, 2007 Received: January 22, 2007
Dear Mr. Devine:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Devine
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation. entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number:
Device Name: Flight Dental Systems A-Series Dental Operative Units
Indications for Use:
Statement of Indication for Use
The Flight Dental Systems A-Series Operative Units are intended to supply power und serve as a base for dental devices and accessories. The use intended is in the treatment of dental patients in the dental clinic/office environment. The units are for use only by trained dentists, dental hygienists, dental technicians and dental assistants.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODF)
Keii Muluy for MSR
(Division Sign-Off) Division of Anesther Nogy, General Hospital, Infection Control, Dental Devices
510(k) Number: K070196
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