(127 days)
Not Found
No
The summary describes a mechanical, air-powered dental handpiece and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
A therapeutic device is one that treats a disease or condition. This device is described as preparing dental cavities for restorations, which is a preparatory step rather than a direct treatment or therapy for a disease.
No
The device is described as preparing dental cavities for restorations through physical actions like drilling and grinding, not by diagnosing conditions.
No
The device description explicitly states it is an "air-powered hand-held device," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prepare dental cavities for restorations through mechanical actions like drilling and grinding. This is a physical intervention on the tooth structure.
- Device Description: The description confirms it's an air-powered hand-held device for mechanical preparation of teeth.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests in vitro (outside the body) on biological samples. This device operates in vivo (within the body) and performs a physical procedure.
N/A
Intended Use / Indications for Use
This device is an air-powered hand-held device, intended to prepare dental cavities for restorations, such as tooth body treatment, tooth drilling and tooth grinding of stomatology.
Product codes
EFB
Device Description
This device is an air-powered hand-held device, intended to prepare dental cavities for restorations, such as tooth body treatment, tooth drilling and tooth grinding of stomatology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
007 1 2 2007
Premarket Notification 510(k) Submission - 510(k) Summary Report No .:
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 9807.92.
1041561 The Assigned 510(k) Number is:
1. Applicant Device Information:
Device Trade/Proprietary Name: Multiple Brand Names Device Common Name: Handpiece, Air Powered, Dental Device Classification Name: Handpiece, Air Powered, Dental Review Panel: Dental Product Code: EFB Regulation Number: 872.4200 Device Class: I Intended Use:
This device is an air-powered hand-held device, intended to prepare dental cavities for restorations, such as tooth body treatment, tooth drilling and tooth grinding of stomatology.
2. Submitter Information:
Establishment Registration Name and Address:
Beijin North Pole Dental Handpiece Co., Ltd Standard Workshop, Area A Beijing Airport Industrial Zone Shunyi, Beijing, P.R.China
Contact Person of the Submission:
Diana Hong Shanghai Mid-link Consulting Co., Ltd. 1441, 6th Avenue San Francisco, California 94122 U.S.A Email: Diana.hong@mid-link.net Fax: 760 466 5084
1
Premarket Notification 510(k) Submission - 510(k) Summary Report No .:
3. Predict Device
PENG LIM High Speed Air Turbine Handpiece
K Number: K062947
Product Code: EFB
Intended Use:
The PENG LIM High Speed Air Turbine Handpieces are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
Manufactured by
PENG LIM ENTERPRISE CO., LTD. 67 Hwa Rong Rd., 2nd F1., Ku Shan Dist. Kaohsiung, CHINA (TAIWAN) Tel: 07-552-2995
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and a circle of text around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Public Health Service
OCT 1 2 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Beijing North Pole Dental Handpiece Company, Limited C/O Ms. Diana Hong General Manger Shanghai Mid-Link Business Consulting Company, Limited Suite 8D, No. 19 Lane 999, Zhongshan No. 2 Road (s) Shanghai 200030 CHINA
Re: K071561
Trade/Device Name: Hi-Speed Turbine Handipieces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: September 17, 2007 Received: September 24, 2007
Dear Ms. Hong:
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 - Ms. Hong
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 (OS) 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,
Swer Runnes
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
Premarket Notification 510(k) Submission-Indications for Use Report No .: A20071028
Indications for Use
1071561 510(k) Number:
Pending
Device Name: Hi-Speed Turbine Handpieces
Indications for Use:
This device is an air-powered hand-held device, intended to prepare dental cavities for restorations, such as tooth body treatment, tooth drilling and tooth grinding of stomatology.
Prescription Use (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)
Susi Russo
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page
510(k) Number: