(28 days)
Not Found
No
The device description focuses on mechanical aspects (gear ratios, coupling, irrigation system) and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is a dental handpiece used for various dental procedures, which are not considered therapeutic interventions in the context of treating or preventing a disease or condition. Its function is primarily to prepare and restore teeth.
No
The device description focuses on its mechanical function (gear-driven handpieces for various dental procedures like drilling, cleaning, and preparing cavities) and does not mention any capability to diagnose conditions or process diagnostic information.
No
The device description clearly describes physical, gear-driven handpieces with integral irrigation systems, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the STRONG Implant Handpieces are used for dental procedures performed directly on the patient's teeth and bone (e.g., root canal preparations, implant surgery, removing carious material). These are in vivo procedures, not in vitro tests on samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or diagnostic results.
Therefore, the STRONG Implant Handpieces are medical devices used for surgical and restorative dental procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The STRONG Implant Handpieces, ACL-411. ACL(B)-411. ACL-421, ACL(B)-421, ACL-431, ACL-(B)-431, ACL-451 and ACL(B)-451, are devices intended for a wide range of dental procedures including:
- · Endodontic surgeries, such as root canal preparations
- · Implunt surgery such as perforating the bone, tapping and threading procedures
- · General dentistry such as removing carious material, cavity and crown preparation, finishing tooth preparations, restorations and polishing teeth
Product codes (comma separated list FDA assigned to the subject device)
EFA
Device Description
The STRONG Implant Handpieces; ACL-411. ACL(B)-41I. ACL-421. ACL(B)-421. ACL-431. ACL-(B)-431. ACL-451 and ACL(B)-451. are gear driven hand-held dental handpieces with transmission ratio of 20:1, 16:1, 32:1 and 64:1. They can be driven by torque adjustable electrical motors for surgery treatment. They are attached to drive via ISO 3964 counling. A Saline inigation system for surgery treatment is integral to the STRONG Implant Handpieces. The head clamp accepts instrument complying with ISO 1797-1. They have contra-angle attachment for difficult to reach areas intended to prepare dental cavities 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
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
SEP = 3 2009
() | Q
Image /page/0/Picture/3 description: The image shows a logo with a stylized letter 'G' on the left and the word "SAESHIN" on the right. The letter 'G' is designed with a curved shape and a triangular cutout, giving it a modern and abstract appearance. The word "SAESHIN" is written in capital letters with a font that has a slightly textured or distressed look.
Saeshin Precision Co., Ltd. #93-15, Palro-Dong, Datseo-Gu, Daegu, 704-220, Republic of Korea
Tel 82 53-587-2345 Fax $2 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: __ January 9, 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 Implant Handpieces Common Name - Denial Handpiece Classification Name - Handpiece, Gear-Driven, Dental
- Device:
3. Predicate Device:
ANTHOGYR Contra Angles and Handpieces, K040674
-
- Classifications Names & Citations:
EFA, 872,4200
- Classifications Names & Citations:
5. Description:
The STRONG Implant Handpieces; ACL-411. ACL(B)-41I. ACL-421. ACL(B)-421. ACL-431. ACL-(B)-431. ACL-451 and ACL(B)-451. are gear driven hand-held dental handpieces with transmission ratio of 20:1, 16:1, 32:1 and 64:1. They can be driven by torque adjustable electrical motors for surgery treatment. They are attached to drive via ISO 3964 counling. A Saline inigation system for surgery treatment is integral to the STRONG Implant Handpieces. The head clamp accepts instrument complying with ISO 1797-1. They have contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.
1
Image /page/1/Picture/0 description: The image shows the logo for GAESHIN. The logo consists of a stylized letter "G" on the left and the word "GAESHIN" on the right. The letter "G" is formed by a crescent shape with a horizontal line cutting through it. The word "GAESHIN" is written in a bold, sans-serif font.
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
The STRONG Implant Handpieces are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. They are substantially equivalent in design, function and intended use to the predicate devices.
-
్లో Indication for use:
The STRONG Implani Handpieces, ACL-411. ACL(B)-411. ACL-421, ACL(B)-421, ACL-431, ACL-(B)-431, ACL-451 and ACL(B)-451, are devices intended for a wide range of dental procedures including: -
· Endodontic surgeries, such as root canal preparations
-
· Implunt surgery such as perforating the bone, tapping and threading procedures
-
· General dentistry such as removing carious material, cavity and crown preparation, finishing tooth preparations, restorations and polishing teeth
-
- Review:
The STRONG Implant Handpieces have the same device characteristics as the predicate device, the ANTHOGYR Contra Angles and Handpieces; 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 rechnical features, the STRONG Implant Handpieces are substantially equivalent to the predicate devices.
8. 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 Sacshin Precision Co., Ltd. concludes that the STRONG Implant Handpieces are safe and effective and substantially equivalent to predicate devices as described herein.
-
- Saeshin Precision Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA.
END
020
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health and Human Services (DHHS). The seal features the DHHS logo, which consists of a stylized caduceus with three snakes intertwined around a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the logo. The image is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60 Silver Spring, MD 20993-0002
Saeshin Precision Company, Limited C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Incorporated 1285 Walt Whitman Road Melville, New York 11747
.
Re: K092412 Trade/Device Name: STRONG Implant Handpieces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFA Dated: August 23, 2009 Received: September 2, 2009
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.
SEP - 3 2009
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.
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
for
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K.092412
510(k) Submission - STRONG Implant Handpieces
510(k) Number K
Device Name: STRONG Implant Handpieces
Indication for use:
The STRONG Implant Handpieces, ACL-411, ACL(B)-411, ACL-421, ACL(B)-421, ACL-431, ACL-(B)-431, ACL-451 and ACL(B)-451, are devices intended for a wide range of dental procedures including:
-
· Endodontic surgeries, such as root canal preparations
ાર -
· Implant surgery such as perforating the bone, tapping and threading procedures
-
· General dentistry such as removing carious material, cavity and crown preparation, finishing tooth preparations, restorations and polishing teeth
Prescription Use (Per 21CFR801 Subpart D) Over-The-Counter Use (Per 21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rinn
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K094112
SAESHIN PRECISION CO., LTD.
01 €