(13 days)
Not Found
No
The document describes mechanical dental handpieces and their intended uses, with no mention of AI or ML technology.
Yes
The device is used for a "wide range of dental procedures" including "surgical modellation," "osteotomia," and "root tip resection," which are therapeutic interventions.
No
Explanation: The device is described as a "Dental Handpiece" used for surgical treatments such as bone removal, osteotomia, and sequestrotomia. These are therapeutic procedures, not diagnostic ones.
No
The device description clearly describes physical dental handpieces with mechanical components (transmission ratio, coupling, head clamp, contra-angle/straight-angle attachment) that are driven by electrical motors. This indicates a 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 describes the device being used for various dental surgical procedures performed directly on the patient's body (e.g., bone removal, osteotomia, root tip resection).
- Device Description: The device description details a mechanical handpiece used for surgical treatment, driven by electrical motors and accepting instruments for procedures within the mouth.
- 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 samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) on biological samples. This device is clearly intended for in vivo (within the body) use during dental surgery.
N/A
Intended Use / Indications for Use
The STRONG Dental Handpieces is indicated for wide range of dental procedures.
- AT II for the application in the area of the front teeth, root tip resection, bone . removal, osteotomia on the upper and lower jaw, preprosthetic surgical modellation, sequestrotomia, fenestration on the alveolar appendix, apical ventilation, bone modellation, bone smoothing.
- ACL-01, ACL(B)-01C and ACL-02C for the osteotomia on the upper and lower ● jaw, germectomia, sequestrotomia.
Product codes (comma separated list FDA assigned to the subject device)
EGS
Device Description
The STRONG Dental Handpieces; AT-II, ACL-01C, ACL(B)-01C and ACL-02C is The STRONG Dental handpieces with transmission ratio of 1:1. It can be driven by torque adjustable electrical motors for surgery treatment. It is attached to drive via ISO 3964 coupline. The head clamp accepts instrument complying with ISO 1797-1. It has contra-angle(AT-II has straight-angle) attachment for difficult to reach 1797-1. It has contra digities for restorations, such as fillings, and for cleaning teeth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Front teeth, root tip, upper and lower jaw, alveolar appendix.
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
019
.
Image /page/0/Picture/2 description: The image shows the logo for SAESHIN. The logo consists of a stylized letter "S" inside of a circle on the left, followed by the word "SAESHIN" in a bold, sans-serif font. The logo is black and white.
Saeshin Precision Co., Ltd.
#93-15, Paho-Dong, Dalseo-Gu, Daegu, 704-220, Republic of Korea Tel 82 53-587-2345 Fax 82 53-587-2347
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92(c).
Date: November 30, 2009
- Company and Correspondent making the submission:
| Company | |
|---|---|
| Name | Saeshin Precision Co., Ltd. |
| Address | #93-15, Paho-dong, Dalseo-Gu, Daegu, 704- |
| 220, Republic of Korea | |
| Phone | |
| Fax | |
| Contact | +82 53-587-2345 |
| +82 53-587-2347 | |
| Y. S. Lee |
-
- Device:
Proprietary Name - STRONG Dental Handpieces Common Name - Dental Handpieces and Accessories Classification Name - Handpiece, Contra- And Right-Angle Attachment, Dental
- Device:
-
- Predicate Device:
-
- Classifications Names & Citations: EGS, 872.4200
-
- Description:
The STRONG Dental Handpieces; AT-II, ACL-01C, ACL(B)-01C and ACL-02C is The STRONG Dental handpieces with transmission ratio of 1:1. It can be driven by torque adjustable electrical motors for surgery treatment. It is attached to drive via ISO 3964 coupline. The head clamp accepts instrument complying with ISO 1797-1. It has contra-angle(AT-II has straight-angle) attachment for difficult to reach 1797-1. It has contra digities for restorations, such as fillings, and for cleaning teeth.
1
Image /page/1/Picture/0 description: The image shows the logo for Saeshin. The logo consists of a stylized letter "S" inside of a circle on the left, followed by the word "SAESHIN" in bold, sans-serif font. The logo is black and white.
Saeshin Precision Co., Ltd.
#93-15, Paho-Dong, Dalseo-Gu, Daegu, 704-220, Republic of Korea Tel 82 53-587-2345 Fax 82 53-587-2347
-
Indication for use: 6.
The STRONG Dental Handpieces is indicated for wide range of dental procedures. -
AT- II for the application in the area of the front teeth, root tip resection, bone . removal, osteotomia on the upper and lower jaw, preprosthetic surgical modellation, sequestrotomia, fenestration on the alveolar appendix, apical ventilation, bone modellation, bone smoothing.
-
ACL-01, ACL(B)-01C and ACL-02C for the osteotomia on the upper and lower . jaw, germectomia, sequestrotomia.
7. Review:
The STRONG Dental Handpieces has the same device characteristics as the predicate The Surgical Contra-Angle handpieces Types WS-56E, Surgical Straight Handpieces Types S-11; intended use, material, design and use concept are similar. And they also comply to ISO 3964 coupling and ISO 1797-1 shank.
Based on the comparison of intended use and technical features, the STRONG Dental Handpieces are substantially equivalent to the predicate devices.
-
- Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Saeshin Precision Co., Ltd. concludes that the STRONG Dental Handpieces is safe and effective and substantially equivalent to predicate devices as described herein.
- Conclusions:
-
- Saeshin Precision Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA.
END
- Saeshin Precision Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Saeshin Precision Company, Limited C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Incorporated Laboratory and Testing 2600 Northwest Lake Road Camas, Washington 98607-9526
Re: K100192
Trade/Device Name: STRONG Dental Handpieces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Acessories Regulatory Class: I Product Code: EGS Dated: January 4, 2010 Received: January 22, 2010
Dear Mr. Mouser:
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.
FEB - 4 2010
3
Page 2 - Mr. Mouser
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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/CDRHOffices/ucm115809.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 vours.
Nh for
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
4
510(k) Number K K106192
Device Name: STRONG Dental Handpieces
Indication for use:
The STRONG Dental Handpieces is indicated for wide range of dental procedures.
- AT II for the application in the area of the front teeth, root tip resection, bone . removal, osteotomia on the upper and lower jaw, preprosthetic surgical modellation, sequestrotomia, fenestration on the alveolar appendix, apical ventilation, bone modellation, bone smoothing.
- ACL-01, ACL(B)-01C and ACL-02C for the osteotomia on the upper and lower ● jaw, germectomia, sequestrotomia.
Prescription Use (Per 21CFR801 Subpart D)
Over-The-Counter Use -(Per 21CFR801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation
R.Shetz, DNS for Dr. K.P. muley
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Uental Devices
510(k) Number: K/00192
SAESHIN PRECISION Co., Ltd.