(203 days)
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No
The summary describes a dental chair and power supply, with no mention of AI or ML capabilities.
No.
The device's intended use is to supply power and serve as a base for dental devices and accessories, including a dental chair, not to directly treat a medical condition.
No
The device is described as a power supply and base for dental devices, including a dental chair. Its function is to support other dental equipment, not to diagnose medical conditions.
No
The intended use and description clearly indicate a physical device (power supply, base for dental devices, dental chair) and not a software-only product.
Based on the provided information, the CHALLENGE-EVER is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "supply power to and serve as a base for dental devices and accessories" and includes a "dental chair." This describes a piece of equipment used in a dental procedure, not a device used to perform tests on samples taken from the body (which is the definition of an IVD).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Reagents or test kits
The CHALLENGE-EVER is a piece of dental equipment used to support dental procedures, not to diagnose conditions based on in vitro testing.
N/A
Intended Use / Indications for Use
The CHALLENGE-EVER is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The unit is intended for use in the dental clinic environment and used by trained dentists and/or dental technicians and assistants.
Product codes
EIA
Device Description
The CHALLENGE-EVER is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
trained dentists and/or dental technicians and assistants / dental clinic environment
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is oriented to follow the curve of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Hallim Dentech Company, Limited C/O Ms. Priscilla Chung Regulatory Affairs Consultant L.K. Consulting Group 2341 West Crescent Avenue, Suite 3 Anaheim, California 92801
FEB 2 5 201
Re: K102223
Trade/Device Name: CHALLENGE-EVER / HL-2060, HL-2060A Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: February 10, 2011 Received: February 11, 2011
Dear Ms. Chung:
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.
1
Page 2- Ms. Chung
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 Fedurement 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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRH/CDRHOffices /usm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Tanner
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, 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): _ K lv 2 2 2 3
CHALLENGE-EVER / HL-2060, HL-2060A Device Name:
Indications For Use:
The CHALLENGE-EVER is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The unit is intended for use in the dental clinic environment and used by trained dentists and/or dental technicians and assistants.
Prescription Use 1 (Per 21 CFR 801 Subpart D)
AND
Over-The Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEE DED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K102223
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K102223 |
|---|---|
| ---------------- | --------- |