(5 days)
Not Found
No
The device description and intended use clearly define a mechanical lubricator and a lubricant, with no mention of AI or ML capabilities.
No.
The document states that the device is used for maintenance of dental handpieces prior to sterilization, not for treating any medical condition or disease.
No
Explanation: The device is described as a handpiece lubricator used for maintenance prior to sterilization, not for diagnosing any medical condition or disease.
No
The device description explicitly mentions a "Lubricator" and "Lubricant," indicating physical components are involved, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the maintenance of dental handpieces prior to sterilization. This is a mechanical/maintenance function, not a diagnostic test performed on biological samples.
- Device Description: The device is a lubricator and lubricant for dental equipment. This aligns with maintenance, not diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information about a patient's health status.
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. This device does not fit that description.
N/A
Intended Use / Indications for Use
The ClearView™ Handpiece Lubricator is used for the delivery of ClearView™M Handpiece Lubricant to air driven dental handpieces, turbines and air motors for the purpose of maintenance prior to sterilization.
Product codes (comma separated list FDA assigned to the subject device)
EFB
Device Description
Lubricator: This information is detailed on the manufacturing drawings and photographs included in the body of this submission.
Lubricant: ClearView™ Dental Handpiece Lubricant is a liquid lubricant specifically intended for use with the ClearView™ Dental Handpiece Lubricator for the purpose outlined above. Detailed information is contained in the body of this submission.
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
0
Section 5 - 510(k) Summary (continued)
Characteristics of the device in comparison to those of the predicate device(s) 6.
Lubricant Comparison:
Both the ClearView™ Dental Handpiece Lubricant and the Phase Change Dental Lubricant are liquids demonstrated to be suitable for lubrication of dental handpieces. They are both considered completely safe under normal usage and have no expected hazards.
Lubricator Comparison:
Both the ClearView™ and the Assistina have a reservoir for lubricant, a cover to contain exhaust, a method of connecting handpieces, push button operation, a hose and connection to a pressurized air supply. Both devices use pressurized air for power and do not have electrical components. Both devices lubricate dental handpieces; however, the ClearView™ does not spray cleaner through the chip air and water line as does the Assistina. The fact that the ClearView™ does not spray cleaner through the chip air and water line does not affect the safety and efficacy of the ClearView™ Dental Handpiece Lubricator for its intended use of lubricating handpieces.
Safety and Performance: 7.
The difference between the ClearView™ Dental Handpiece Lubricator and Lubricant and the above mentioned predicate devices do not raise any questions regarding the safety and effectiveness of the lubricator or lubricant. The ClearView™ Dental Handpiece Lubricator employs the same technological characteristics to support the intended use of lubricating air-driven dental handpieces with rotating turbines and purge old lubricant for the purpose of maintenance prior to sterilization as the W & H Assistina. In addition, the ClearView™ Dental Handpiece Lubricant and the predicate device, the Phase Change Dental Lubricant, are commonly used in equipment with incidental food contact. The devices, as designed, are as safe and effective as their predicate devices.
Conclusion 8.
Based on the design, material, function and intended use discussed herein, Dental Air Solutions of NC, Inc., believes the ClearView™ Dental Handpiece Lubricator and Lubricant is substantially equivalent to predicate devices currently marketed under the Federal Food, Drug and Cosmetic Act.
1
Section 5 - 510(k) Summary
Applicant Contact: 1.
....
Thomas K. Fee, President Dental Air Solutions of NC, Inc. 224 Branchside Lane Holly Springs, NC 27540 Phone: 919-771-7545 Fax: 919-762-9070 Email: tomf(@dentalairsolutions.com
Date Prepared: November 17, 2006
Name of Device: ClearView™ Dental Handpiece Lubricator and Lubricant 2. Common Name: Dental Handpiece Accessory (maintenance, lubrication) Accessory to Dental Handpiece, Class I medical device Classification Name: Regulation 21 CFR 872.4200, Product Code EFB
Identification of device(s) to which the submitted claims equivalence: 3.
The Clear View™ Dental Handpiece Lubricator and Lubricant is substantially equivalent to the following predicate devices:
- a. Predicate for Lubricator:
- W & H Assistina, 510(k) K010127 트
- b. Predicate for Lubricant:
- Phase Change Dental Lubricant, 510(k) K954991 u
4. Device Description:
Lubricator: This information is detailed on the manufacturing drawings and photographs included in the body of this submission.
Lubricant: ClearView™ Dental Handpiece Lubricant is a liquid lubricant specifically intended for use with the ClearView™ Dental Handpiece Lubricator for the purpose outlined above. Detailed information is contained in the body of this submission.
Intended Use of the Device: ડ.
The ClearView7M Handpiece Lubricator is used for the delivery of ClearView™ Handpiece Lubricant to air driven dental handpieces, turbines and air motors for the purpose of maintenance prior to sterilization.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dental Air Solutions of North Carolina, Incorporated C/O Mr. Jeff D. Rongero Responsible Third Party Official Underwriters Laboratories, Incorporated FEB 5 2007 12 Laboratory Drive Research Triangle Park, North Carolina 27709-3995
Re: K070297
Trade/Device Name: ClearView™ Dental Handpiece Lubricator and Lubricant Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: January 24, 2007 Received: January 31, 2007
Dear Mr. Rongero:
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.
3
Page 2 - Mr. Rongero
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 vours.
Qur
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
4
Section 4 - Indications for Use Statement
510k number if known:
1070297
ClearView™ Dental Handpiece Lubricator and Lubricant Device Name:
Indications for Use:
The ClearView™ Handpiece Lubricator is used for the delivery of ClearView™M Handpiece Lubricant to air driven dental handpieces, turbines and air motors for the purpose of maintenance prior to sterilization.
Prescription Use ﮯ (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 (ODE)
Susan Runner
ClearView™ Dental Handpiece Lubricator and Lubricant