(156 days)
Not Found
Not Found
No
The summary describes a standard low-speed dental handpiece and does not mention any AI or ML capabilities.
Yes
The device is used in various dental procedures to treat conditions like caries or for root canal enlargement, which are therapeutic interventions.
No
Explanation: The device is described as a low-speed handpiece used in various dental procedures (e.g., drilling, root canal enlargement, caries removal), which are interventional or treatment-oriented, not diagnostic.
No
The device description is not found, but the intended use clearly describes a "lowspeed handpiece," which is a physical, hardware device used in dental procedures. This indicates it is not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in the mouth for mechanical procedures (drilling, cleaning, etc.). IVDs are used to examine specimens from the body (blood, urine, tissue, etc.) to provide information about a person's health.
- Device Description: While the description is "Not Found," the intended use clearly points to a physical tool used directly on the patient.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on laboratory tests.
- Using reagents or assays.
This device is a dental handpiece, which is a surgical/procedural tool, not a diagnostic device.
N/A
Intended Use / Indications for Use
The Indications for Use of this device is to provide a dental professional a lowspeed handpiece which may be used, in conjunction with various dental burs as identified by the dental professional, in the performance of various dental procedures including, but not limited to, Prophy, Post and Pin Drilling, Pin Setting, Root Canal Enlargement and Sealing, and Caries Removal.
Product codes
EGS
Device Description
Dental Handpiece; Speed Reduction Angle
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 professional
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR lagga
Mr. Robert E. Booth ·Director, Regulatory Affairs/Quality Midwest Dental Products 901 West Oakton Street Des Plaines, Illinois 60018
Re : K973800 23:1 Reduction Angle Trade Name: Regulatory Class: I EGS Product Code: Dated: December 22, 1997 Received: December 29, 1997
Dear Mr. Booth:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with " the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Booth
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on ........ the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K973800/A'
Image /page/2/Picture/1 description: The image shows the logo for Dentsply Midwest. The word "DENTSPLY" is in a bold, sans-serif font, with the letters slightly overlapping. Below it, the word "MIDWEST" is in a smaller, italicized, sans-serif font. The logo is in black and white.
Midwest Dental Products Division of DENTSPLY International 901 West Oakton Street Des Plaines, IL 60018-1884 Phone (847) 640-4800 Fax (847) 640-6165
Statement of Indications for Use
Dental Handpiece; Speed Reduction Angle 510(k) Number: K973800
The Indications for Use of this device is to provide a dental professional a lowspeed handpiece which may be used, in conjunction with various dental burs as identified by the dental professional, in the performance of various dental procedures including, but not limited to, Prophy, Post and Pin Drilling, Pin Setting, Root Canal Enlargement and Sealing, and Caries Removal. The intended patient population is the general population requiring such procedures.
Respectfully Submitted DENTSPLY Midwe
Robert E. Booth Director, Regulatory Affairs/Quality
| 1 | 80 M | ರ್ವಾತ್ರಗಳಲ್ಲೇ ದೇಶದಲ್ಲಿ ಪ್ರಸಿದ್ಧ |
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| । ਹ | America | ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ |
| ਈ ਹੈ। | 2 | ting the first |
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| 试法公司 >> 中 | ||
| ుండి 10 కి.మీ. దూరం | ||
| F | រីក | ية 1545 منذ 145 أسماء |
| ਹੈ ਕਿ ਉਹ | د. | ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ |
Susan Runser
(Division Sign-Off) (Division of Dental. Infection Control, and General Hospital Devices 3800 510(k) Number
Prescription Use (Per 21 CFR 801.109)
SK=69