(276 days)
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Not Found
No
The provided 510(k) summary describes a dental handpiece and its intended uses, none of which mention or imply the use of AI or ML technology. The summary lacks sections typically found in submissions for AI/ML devices, such as descriptions of training/test sets, performance studies, or key metrics related to algorithmic performance.
No
The device is used for dental procedures such as implant placement, periodontal surgeries, bone grafting, and tooth removal. These are interventional procedures rather than therapeutic.
No
Explanation: The device description outlines procedures for implant placement, periodontal surgeries, bone grafting, and tooth removal. These are all therapeutic or surgical interventions, not diagnostic ones. There is no mention of the device being used to identify or analyze a disease or condition.
No
The device description is not found, but the intended use clearly describes a "Strong Dental Handpiece," which is a physical, hardware-based medical device used in dental procedures. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures on the human body (implant placement, periodontal surgeries, bone grafting, tooth removal).
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health.
This device is a surgical tool, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The Strong Dental Handpiece, ACL(B)-46EP is intended for wide range of dental procedures, including:
A. Implant placement, including
-
- Preparation of the osteotomy site
-
- Bone contouring, osteoplasty
- B. Periodontal surgeries
-
- Bone contouring & alveoplasty around living teeth
-
- Removal of exostosis
- C. Bone grafting
- 1.Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
-
- Harvesting autogen living bone
-
- Sinus elevation & grafting of alveolar sockets
D. Removal and sectioning of teeth and teeth bone for e.g. impacted third molars and complicated extractions.
Product codes
EGS
Device Description
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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
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)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Saeshin Precision Co., Ltd. Choi Jong Woo Quality Manager 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun Daegu, 42921 KOREA
January 31, 2019
Re: K181129
Trade/Device Name: STRONG Dental Handpieces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EGS Dated: December 24, 2018 Received: January 1, 2019
Dear Choi Jong Woo:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Mary S. Runner Digitally signed by Mary S. -S3 - - - - Date: 2019.01.31 15:33:13
-53 - - - - - Date: 2019.01.31 15:33:13
-05:00 -- --------------------------------------------------------------------------------------
forTina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, 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) K181129
Device Name STRONG Dental Handpieces
Indications for Use (Describe) The Strong Dental Handpiece, ACL(B)-46EP is intended for wide range of dental procedures, including:
A. Implant placement, including
-
- Preparation of the osteotomy site
-
- Bone contouring, osteoplasty
- B. Periodontal surgeries
-
- Bone contouring & alveoplasty around living teeth
-
- Removal of exostosis
- C. Bone grafting
- 1.Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
-
- Harvesting autogen living bone
-
- Sinus elevation & grafting of alveolar sockets
D. Removal and sectioning of teeth and teeth bone for e.g. impacted third molars and complicated extractions.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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