(234 days)
No
The description focuses on the mechanical aspects and intended uses of dental handpieces, with no mention of AI or ML capabilities.
No
The device is a hand-held dental tool used for various dental procedures, it does not directly provide therapy.
No
Explanation: The device description and intended use clearly state that these dental handpieces are used for various dental procedures such as implant placement, bone contouring, tooth removal, and cavity preparation. These are all interventional or treatment procedures, not diagnostic ones. There is no mention of the device being used to identify or analyze a medical condition.
No
The device description clearly states it is a "gear driven hand-held dental handpiece" and mentions physical components like gear ratios, motors, couplings, and head clamps, indicating it is a hardware 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 the device as being used for various dental procedures involving bone and teeth, such as implant placement, periodontal surgeries, bone grafting, and tooth removal. These are all procedures performed on the patient's body.
- Device Description: The description details a mechanical dental handpiece used for preparing cavities and cleaning teeth. This is a physical tool used directly in 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 perform tests outside of the body on biological samples. This device is a surgical tool used within the body.
N/A
Intended Use / Indications for Use
The STRONG Dental Handpieces, ACL(B)-611, ACL(B)-631, ACL(B)-651 and ACL(B)-04C are intended for a 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
-
- 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 bone for e.g. impacted third molars and complicated extractions
Product codes
EGS
Device Description
The STRONG Dental Handpieces; ACL(B)-611, ACL(B)-621, ACL(B)-631, ACL(B)-65| and ACL(B)-04C are gear driven hand-held dental handpieces with Gear Ratio of 20:1, 16:1, 64:1, 32:1 and 1:1. They can be driven by torque adjustable electrical motors for surgery treatment. They are attached to drive via ISO 3964 coupling. The head clamp accepts instrument complying with ISO 1797-1. They have contra-angle attachment 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)
Biocompatibility
The materials contacting patients of chuck, head and nozzle were totally same and have previously cleared by FDA through STRONG Implant Handpieces (K092412) of predicate device, STRONG Dental Handpiece. The biocompatibility test report has been issued by Korea Testing & Research Institute, 7-6, Gomak-Ri, Wolgot-Myeon, Gimpo-Si, Gyunggi-Do, 415-871, Korea for the predicate is applicable to the subject device:
- Cytotoxicity per ISO 10993-5
- Sensitization per ISO 10993-10
- Irritation per ISO 10993-10
The device complies with the ISO10993-1 standard, and the materials contacting patients are biocompatible.
Bench Testing
The bench tests were performed in order to ensure the performance of the STRONG Dental Handpieces, ACL(B)-611, ACL(B)-621, ACL(B)-631, ACL(B)-651 and ACL(B)-04C verify conformity to ISO 14457 and demonstrate substantial equivalence to the predicates.
ACL(B)-611, ACL(B)-62l, ACL(B)-63l, ACL(B)-65l and ACL(B)-04C samples were compliant with ISO 14457: 2012 Dentistry - Handpieces And Motors and demonstrated substantial equivalence to the predicates.
Sterilization
The STRONG Dental handpieces, ACL(B)-611, ACL(B)-621, ACL(B)-631, ACL(B)-65| and ACL(B)-04C are provided nonsterile and labeled for sterilization by the end user.
The sterilization method was validated per :.
- Reprocessing validation per the FDA Guidance Document entitled, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" dated March 17, 2015
- Cleaning Process Validation per ASTM F2314 and ISO 15883-5
- Sterilization Validation per ISO 17665-1 and ISO 17665-2
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "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 Republic of Korea
January 5, 2018
Re: K171436
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 5, 2017 Received: December 5, 2017
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 -S
For Tina 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
STRONG Dental Handpieces
Indications for Use (Describe)
The STRONG Dental Handpieces, ACL(B)-611, ACL(B)-631, ACL(B)-651 and ACL(B)-04C are intended for a 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
-
- 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 bone for e.g. impacted third molars and complicated extractions
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995,
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
Image /page/3/Picture/1 description: The image shows the logo and contact information for Saeshin. The address is # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 42921, Korea. The telephone number is +82 53 587 2345, and the fax number is +82 53 580 0939.
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(1)]
January 2, 2018
2. Submitter's Information [21 CFR807.92(a)(1)]
- Name of Applicant: Saeshin Precision Co., Ltd. .
-
52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Address: -Daegu, 42921, Republic of Korea
-
- . Contact Name: Jong Woo, Choi (Mr.) / Quality Manager
- Telephone No. : +82 53 587 2345 -
- Fax No. : +82 53 580 0939
- Email Address : ksqc@saeshin.com -
- Telephone No. : +82 53 587 2345 -
- Registration Number: 3007958831 .
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
- Trade Name: STRONG Dental Handpieces . Classification Name: Dental Handpieces and Accessories . . Common Name: Handpiece, Contra- And Right-Angle Attachment, Dental Classification Panel: . Dental Classification Requlation: 21 CFR 872.4200 . Product Code: EGS •
General Information
STRONG Dental Handpieces
4
Image /page/4/Picture/0 description: The image shows the company information for Saeshin. The address is # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 42921, Korea. The telephone number is +82 53 587 2345, and the fax number is +82 53 580 0939. The Saeshin logo is at the top of the image.
- . Device Class: ------
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[
The identified predicate devices within this submission are shown as follows:
- 510(k) Number: K143418 •
- Applicant: • Saeshin Precision Co., Ltd.
- Common Name: Dental Handpieces and Accessories
- Device Name: STRONG Dental Handpieces, •
There are no significant differences between the Model STRONG Dental Handpieces and the predicate device. It is substantially equivalent to these devices in device design, composition of materials and technical specifications.
5. Description of the Device [21 CFR 807.92(a)(4)]
The STRONG Dental Handpieces; ACL(B)-611, ACL(B)-621, ACL(B)-631, ACL(B)-65| and ACL(B)-04C are gear driven hand-held dental handpieces with Gear Ratio of 20:1, 16:1, 64:1, 32:1 and 1:1. They can be driven by torque adjustable electrical motors for surgery treatment. They are attached to drive via ISO 3964 coupling. The head clamp accepts instrument complying with ISO 1797-1. They have contra-angle attachment intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.
6. Intended Use [21 CFR 807.92(a)(5)]
The STRONG Dental Handpieces, ACL(B)-611, ACL(B)-62l, ACL(B)-63l, ACL(B)-65l and ACL(B)-04C are intended for a wide range of dental procedures including:
- A. Implant placement, including
-
- Preparation of the osteotomy site
-
- Bone contouring, osteoplasty
-
General Information
STRONG Dental Handpieces
5
Image /page/5/Picture/0 description: The image shows the contact information for Saeshin. The address is # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 42921, Korea. The telephone number is +82 53 587 2345, and the fax number is +82 53 580 0939.
- B. Periodontal surgeries
-
- Bone contouring & alveoplasty around living teeth
-
- Removal of exostosis
-
- C. Bone grafting
-
- 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
7. Technological Characteristics [21 CFR 807.92(a)(6)]
| ACL(B)-61I | ACL(B)-62I | ACL(B)-63I | ACL(B)-65I | ACL(B)-04C | ||
|---|---|---|---|---|---|---|
| Revolution | Max Speed | |||||
| in Rpm | 50,000rpm | 50,000rpm | 50,000rpm | 50,000rpm | 35,000rpm | |
| After the gear | ||||||
| speed reduction | 2,500rpm | 3,125rpm | 781rpm | 1,562rpm | 35,000rpm | |
| Gear Ratio | 20:1 | 16:1 | 64:1 | 32:1 | 1:1 | |
| Weight | approx. | |||||
| 50g | approx. | |||||
| 50g | approx. | |||||
| 55g | approx. | |||||
| 50g | approx. | |||||
| 47g | ||||||
| Size | Ø19.6x | |||||
| 96.9mm | Ø19.6x | |||||
| 96.9mm | Ø19.6x | |||||
| 99.5mm | Ø19.6x | |||||
| 96.9mm | Ø19.6x | |||||
| 83.3mm | ||||||
| Articles | Low speed | |||||
| angle | Low speed | |||||
| angle | Low speed | |||||
| angle | Low speed | |||||
| angle | Low speed | |||||
| angle | ||||||
| Standard Coupling | ISO 3964 | ISO 3964 | ISO 3964 | ISO 3964 | ISO 3964 |
6
Image /page/6/Picture/0 description: The image shows the logo and contact information for Saeshin. The logo is a blue geometric shape above the company name, "SAESHIN," which is written in a stylized blue font. Below the logo is the address: # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 42921, Korea, followed by the telephone number: +82 53 587 2345 and fax number: +82 53 580 0939.
8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]
When compared to the predicate device (K143418) the STRONG Dental Handpieces presented in this submission has the same:
- Intended Use •
- Device Design •
- Composition of materials •
- Technical Specifications •
| Parameter | Proposed | Predicate |
|---|---|---|
| STRONG Dental Handpieces (Model Nos.: | ||
| ACL(B)-61I, ACL(B)-62I, ACL(B)-63I, | ||
| ACL(B)-65I, ACL(B)-04C) | STRONG Dental Handpieces (Model Nos.: | |
| ACL(B)-03C, ACL(B)-03F) | ||
| 510(k) Number | Unknown | K143418 |
| Manufacturer | Saeshin Precision Co., Ltd | Saeshin Precision Co., Ltd. |
| Intended Use | The Strong Dental Handpieces are indicated | |
| for wide range of dental procedures. | ||
| 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 - Preparation of the donor site (for
e.g. symphysis and ascending
rames etc.) - Harvesting autogen living bone | The Strong Dental Handpieces are indicated
for wide range of dental procedures.
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 - Preparation of the donor site (for
e.g. symphysis and ascending
rames etc.) - Harvesting autogen living bone |
| Parameter | Proposed
STRONG Dental Handpieces (Model Nos.: | Predicate
STRONG Dental Handpieces (Model Nos.: |
| | ACL(B)-61I, ACL(B)-62I, ACL(B)-63I,
ACL(B)-65I, ACL(B)-04C) | ACL(B)-03C, ACL(B)-03F) |
| | 3. Sinus elevation & grafting of alveolar
sockets | 3. Sinus elevation & grafting of alveolar
sockets |
| | D. Removal and sectioning of teeth and
teeth bone for e.g. impacted third
molars and complicated extractions | D. Removal and sectioning of teeth and
teeth bone for e.g. impacted third molars
and complicated extractions |
| Device Design | | |
| Operational Mode | Gear | Gear |
| Gear Ratio | 20:1, 16:1, 64:1, 32:1, 1:1 | 1:1 |
| Length | 96.9, 96.9, 99.5, 96.9, 83.3 mm | 83.7 mm |
| Diameter | Ø 19.6 | Ø 19.6 |
| Dia. of tool | 2.35 mm | 2.35, 1.60 mm |
| Max. Overall Length of
Rotary Instrument | 30 mm | 30 mm |
| Head Height | 14.45,14.2 mm | 13.7 mm |
| Head Diameter | Ø 8, Ø 7.7 mm | Ø 8 mm |
| Shank | By ISO1797-1 | By ISO1797-1 |
| Length of Shank | 9 – 12 mm | 9 – 12 mm |
| Type of Chuck | Push-Button Locking | Push-Button Locking |
| Coupling Dimension | By ISO 3964 | By ISO 3964 |
| Type of Connector | Not Applied | Not Applied |
| Accessories | Spanner | Spanner |
| Composition of Materials
/Surface treatment | | |
| Gear | SUS420F/Vacuum Heat Treatment | SUS420F/Vacuum Heat Treatment |
| Shank | SUS304 | SUS304 |
| Head and Nozzle | SUS303F/Hard Chrome coated | C3604BD-F/Hard Chrome Coated |
| Chuck | SUS420F/Vacuum Heat Treatment | SUS420F/Vacuum Heat Treatment |
| Handle | AL6061/Anodizing | AL6061/Anodizing |
| Pipe | SUS303F/Hard Chrome coated | N/A |
| Parameter | Proposed | Predicate |
| | STRONG Dental Handpieces (Model Nos.: | STRONG Dental Handpieces (Model Nos.: |
| | ACL(B)-61I, ACL(B)-62I, ACL(B)-63I,
ACL(B)-65I, ACL(B)-04C) | ACL(B)-03C, ACL(B)-03F) |
| | N/A (ACL(B)-04C) | |
| Patient-Contacting | Chuck, Head | Chuck, Head |
| Operator-Contacting | Handle, Head | Handle, Head |
| Technical Specification | | |
| Chuck Design | Type1 Push-Button Locking by ISO 1797-1 | Type1 and Type 3 Push-Button Locking by
ISO 1797-1 |
| Bur Extraction Force(N) | 45 N | 45 N, 22N |
| Max. Torques | 50 Ncm | 50 Ncm |
| Max. Water Pressure | N/A | N/A |
| Max. Speed in rpm | 50,000 rpm, 35,000 rpm | 35,000 rpm |
| Shank Conformance | By ISO 1797-1 | By ISO 1797-1 |
| Coupling Dimension | By ISO 3964 | By ISO 3964 |
| Lubricant | | |
| Chemical Composition | N/A | N/A |
| | 510k#
Biocompatible
Delivery system | |
| Sterilization | Steam Heat 132 ℃/4minutes | Steam Heat 132 ℃/4minutes |
| Operating principle | Image: dental handpiece | Image: dental handpiece |
| | The STRONG Dental Handpieces, ACL(B)-
611,
ACL(B)-621, ACL(B)-631, ACL(B)-651
and ACL(B)-04C are gear driven hand-held
dental handpieces with gear ratio of 20:1,
16:1, 64:1, 32:1 and 1:1. It can be driven by
torque adjustable electrical motors for | The STRONG Dental Handpieces, ACL(B)–
03C and ACL(B)-03F, are gear driven hand-
held dental handpieces with gear ratio of 1:1.
It can be driven by torque adjustable
electrical motors for surgery treatment. It is
attached to drive via ISO 3964 coupling. The
head clamp accepts instrument complying |
| Parameter | Proposed
STRONG Dental Handpieces (Model Nos.:
ACL(B)-61I, ACL(B)-62I, ACL(B)-63I,
ACL(B)-65I, ACL(B)-04C) | Predicate
STRONG Dental Handpieces (Model Nos.:
ACL(B)-03C, ACL(B)-03F) |
| | surgery treatment. It is attached to drive via
ISO 3964 coupling. 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. | 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. |
7
Image /page/7/Picture/0 description: The image shows the logo and address of a company called SAESHIN. The logo is a blue geometric shape. The address is # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 42921, Korea.
Tel: +82 53 587 2345 / Fax: +82 53 580 0939
8
Image /page/8/Picture/0 description: The image shows the logo and contact information for SAESHIN. The logo is a blue geometric shape. The address is # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 42921, Korea. The telephone number is +82 53 587 2345 and the fax number is +82 53 580 0939.
9
Image /page/9/Picture/0 description: The image shows the logo and contact information for SAESHIN. The logo is a blue geometric shape. The address is # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 42921, Korea. The telephone number is +82 53 587 2345 and the fax number is +82 53 580 0939.
10
Image /page/10/Picture/0 description: The image shows the logo and contact information for Saeshin. The logo is a blue geometric design. The contact information includes the address, which is # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 42921, Korea, as well as the telephone number, which is +82 53 587 2345, and the fax number, which is +82 53 580 0939.
9. Summary of Non-Clinical Performance Data
| Biocompatibility
The materials contacting patients of chuck, head and nozzle were totally same and have previously cleared by by FDA through STRONG been l m plan t Handpieces (K092412) of predicate device, STRONG Dental Handpiece. The biocompatibility test report has been issued by Korea Testing & Research Institute, 7-6, Gomak-Ri, Wolgot-Myeon, Gimpo-Si, Gyunggi-Do, 415-871, Korea for the predicate is applicable to the subject device:
- · Cytotoxicity per ISO 10993-5
- · Sensitization per ISO 10993-10
- · Irritation per ISO 10993-10
The device complies with the ISO10993-1 standard, and the materials contacting patients are biocompatible.
I Bench Testing
The bench tests were performed in order to ensure the performance of the STRONG Dental Handpieces, ACL(B)-611, ACL(B)-621, ACL(B)-631, ACL(B)-651 and ACL(B)-04C verify conformity to ISO 14457 and demonstrate substantial equivalence to the predicates.
ACL(B)-611, ACL(B)-62l, ACL(B)-63l, ACL(B)-65l and ACL(B)-04C samples were compliant with ISO 14457: 2012 Dentistry - Handpieces And Motors and demonstrated substantial equivalence to the predicates.
General Information
STRONG Dental Handpieces
11
Image /page/11/Picture/0 description: The image shows the logo and contact information for SAESHIN. The address is # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 42921, Korea. The telephone number is +82 53 587 2345, and the fax number is +82 53 580 0939. The logo is a blue geometric shape above the company name.
. Sterilization
The STRONG Dental handpieces, ACL(B)-611, ACL(B)-621, ACL(B)-631, ACL(B)-65| and ACL(B)-04C are provided nonsterile and labeled for sterilization by the end user, the Instructions for use include the following parameters:
| Sterilization Type | Temperature | Time | Load
Characteristics | Dry Time |
|------------------------------------------|-------------|--------|-------------------------|----------|
| Steam Sterilization
(Pre-vacuum Type) | 132 ℃ | 4 min. | Sterilization Baq | 30 min. |
The sterilization method was validated per :.
- Reprocessing validation per the FDA Guidance Document entitled, "Reprocessing . Medical Devices in Health Care Settings: Validation Methods and Labeling" dated March 17, 2015
- Cleaning Process Validation per ASTM F2314 and ISO 15883-5 .
- Sterilization Validation per ISO 17665-1 and ISO 17665-2 .
10. Conclusion [21 CFR 807.92(b)(3)]
In accordance with the Federal Food, Drug and Cosmetic, 21 CFR Part 807, and based on the information provided in this premarket notification Saeshin Presicion Co., Ltd. Concludes that the STRONG Dental Handpieces are substantially equivalent to predicate devices as described herein.