(245 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
Yes
The device is described as being used for various dental procedures such as implant placement, periodontal surgeries, bone grafting, and removal/sectioning of teeth, all of which are considered therapeutic interventions.
No
Explanation: The device description and intended use clearly indicate that the STRONG Dental Handpieces are used for various dental procedures such as implant placement, bone contouring, and removal of teeth, which are all treatment-oriented actions, not diagnostic ones. There is no mention of the device being used to identify or analyze medical conditions.
No
The device description clearly states it is a "gear driven handheld dental handpiece" and describes physical components and performance characteristics related to hardware (extraction force, eccentricity, temperature rise, resistance to sterilization). There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use of the STRONG Dental Handpieces clearly indicate they are used for surgical procedures directly on the patient's body (implant placement, periodontal surgeries, bone grafting, tooth removal). They are mechanical tools for manipulating tissue.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens.
Therefore, based on the provided information, the STRONG Dental Handpieces are not IVD devices. They are surgical instruments.
N/A
Intended Use / Indications for Use
The STRONG Dental Handpieces. ACL(B)-03C and ACL(B)-03F. 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 and teeth bone for e.g. impacted third molars and complicated extractions
Product codes (comma separated list FDA assigned to the subject device)
EGS
Device Description
The STRONG Dental Handpieces; ACL(B)-03C and ACL(B)-03F are gear driven handheld dental handpieces with Gear Ratio of 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 for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.
The STRONG Dental Handpieces are similar to other commercially available products based on intended use, material, design and use concept. And they also comply with ISO 3964 coupling and ISO 1797-1 shank.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dental cavities, osteotomy site, bone, symphysis, ascending rames, alveolar sockets, teeth, teeth bone.
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)
Bench Testing:
Performed to ensure the performance of the STRONG Dental Handpieces, ACL(B)-03C and ACL(B)-03F, verify conformity to ISO 14457 and demonstrate substantial equivalence to the predicates.
ACL(B)-03C and ACL(B)-03F samples were compliant with ISO 14457: 2012 Dentistry - Handpieces And Motors and demonstrated substantial equivalence to the predicates.
-
Visual inspection of general design:
- Test performed with normal visual and profile projector.
- Result: All the articles comply with the acceptance criteria of Section 7.2 of the handpiece standard.
-
Extraction force:
- ACL(B)-03C: Mean (N) = 51.2 N (acceptance criteria: at least 45N)
- ACL(B)-03F: Mean (N) = 32.2 N (acceptance criteria: at least 22N)
-
Eccentricity:
- ACL(B)-03C: Mean (mm) = 0.014
- ACL(B)-03F: Mean (mm) = 0.012
- Result: The eccentricity of the test mandrel in rotation and without applied load did not exceed the total indicated run-out of 0.08 mm.
-
Resistance to sterilizing procedure:
- Test: After 250 cycles of 132 °C for 4 minutes in the autoclave.
- Result: No sign of deterioration détecté. ACL(B)-03C: Extraction 51.2 N, Max. speed 35,120 rpm, Noise 55 dB. ACL(B)-03F: Extraction 32.2 N, Max. speed 35,090 rpm, Noise 54 dB.
-
Temperature rise:
- ACL(B)-03C: Mean (°C) = 10
- ACL(B)-03F: Mean (°C) = 6
- Result: Rise of maximum temperature at the touchable surface of the housing under rated running conditions did not exceed 20℃ compared to the temperature of the environment.
-
Resistance to corrosion:
- Test: Autoclave procedure 10 times at 132 ℃ for 4 minutes at 22kPa.
- Result: Handpieces are corrosion resistant. No signs of corrosion.
Clinical and non-clinical tests:
A non-clinical evaluation, based on literature research, has been done. The evaluation of the applicable market data showed that STRONG Dental handpieces, ACL(B)-03C and ACL(B)-03F, do not pose known or new clinical risks than similar medical devices currently on the market. Based on those results clinical test have not been executed.
Biocompatibility:
The materials contacting patients of chuck and the head were totally same and have been previously cleared by FDA through K100192 of predicate device, STRONG Dental Handpiece. The test report has been issued by Korea Testing & Research Institute. The categorization of contact was established under ISO 10993-1:2009-10-15. According to the recommendations in this standard and FDA Blue Book Memo #G95-1, the following tests are applicable and were performed:
- Cytotoxicity according to ISO 10993-5
- Sensitization according to ISO 10993-10
- Irritation or intracutaneous reactivity according to ISO 10993-10
Sterilization:
The STRONG Dental handpieces, ACL(B)-03C and ACL(B)-03F, are provided nonsterile and labeled for sterilization by the end user. The Instructions for use include the following parameters:
- Sterilization Type: Steam Sterilization (Pre-vacuum Type)
- Temperature: 132 °C
- Time: 4 min.
- Load Characteristics: Sterilization Bag
- Dry Time: 30 min.
The sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products – Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus-like symbol with three human profiles merging into a single form, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The seal is simple, using black lines on a white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 31, 2015
Saeshin Precision Co., Ltd. Choi Sae Kwan Quality Assurance Manager 52 Secheon-ro 1-gil, Dasa-eup Dalseong- gun, Daegu 711-814 KOREA
Re: K143418
Trade/Device Name: STRONG Dental Handpieces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental handpiece and accessories Regulatory Class: I Product Code: EGS Dated: June 18, 2015 Received: June 22, 2015
Dear Choi Sae Kwan:
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.
1
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 (QS) 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Tina
Kiang -S
for Erin I. Keith, M.S. 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) K143418
Device Name STRONG Dental Handpieces
Indications for Use (Describe)
The STRONG Dental Handpieces. ACL(B)-03C and ACL(B)-03F. 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 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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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."
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Image /page/4/Picture/0 description: The image contains the logo for Saeshin. The logo consists of a blue geometric shape above the company name, "SAESHIN," which is written in a stylized, sans-serif font, also in blue. The geometric shape is composed of several smaller triangles arranged to form a larger, abstract design.
52, Secheon-ro 1-gil, Dasa-eup, Dalseong-Tel: +82 53 587 2341 / Fax: +82 53 580 0
510(k) Summary
[As required by 21 CFR 807.92] This 510(k) summary is prepared in accordance with 21 CFR807.92
1. Date Prepared [21 CFR 807.92(a)(1)]
10/28/2014
2. Submitter's Information [21 CFR807.92(a)(1)]
- . Name of Sponsor: Saeshin Precision Co., Ltd.
- -Address: # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 711-814, Republic of Korea
- Contact Name: Sae Kwan, Choi (Mr.) / Quality Manager ●
- -Telephone No. : +82 53 587 2341
- -Fax No. : +82 53 580 0999
- -Email Address : ksqc@saeshin.com
- Registration Number: ● 3007958831
- Name of Manufacturer: Same as Sponsor
- Same as Sponsor -Address:
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
- . Trade Name: STRONG Dental Handpieces
- . Common Name: Dental Handpiece and Accessories
- Classification Name: Dental Handpiece and Accessories
- . Classification Panel: Dental
- Classification Regulation: ● 21 CFR 872.4200
- . Product Code: EGS
5
- . Device Class:
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
l
The identified predicate devices within this submission are shown as follows:
- 510(k) Number: K100192
- Applicant: . Saeshin Precision Co., Ltd.
- Common Name: Dental Handpieces and Accessories ●
- Device Name: STRONG Dental Handpieces .
There are no significant differences between the proposed models of STRONG Dental Handpieces and the predicate device that would adversely affect the use of the product. 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)-03C and ACL(B)-03F are gear driven handheld dental handpieces with Gear Ratio of 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 for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.
The STRONG Dental Handpieces are similar to other commercially available products based on intended use, material, design and use concept. And they also comply with 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
6. Intended Use [21 CFR 807.92(a)(5)]
The STRONG Dental Handpieces, ACL(B)-03C and ACL(B)-03F, 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
-
6
- 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)-03C | ACL(B)-03F | |
|---|---|---|
| Revolution | 0~35,000RPM | 0~35,000RPM |
| Gear Ratio | 1:1 | 1:1 |
| Weight | approx. 45g | approx. 46g |
| Size | Ø19.6x 83.7mm | Ø19.6x 83.7mm |
| Articles | Low speed angle | Low speed angle |
| Standard | ||
| Coupling | ISO 3964 | ISO 3964 |
3 / 10
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Image /page/7/Picture/0 description: The image shows the logo and address of a company called SAESHIN. The address is # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 711-814, Korea. The phone number is +82 53 587 2341 and the fax number is +82 53 580 0999.
8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]
When compared to the predicate device (K100192), 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)-03C and ACL(B)-03F) | STRONG Dental Handpieces (Model Nos.: | |
| AT- II, ACL-01C, ACL-02C and ACL(B)-01C) | ||
| 510(k) Number | Unknown | K100192 |
| Manufacturer | Saeshin Precision Co., Ltd | Saeshin Precision Co., Ltd. |
| The Indications for Use | ||
| are the same in the | ||
| predicate and proposed | ||
| devices, except that the | ||
| terms used in the | ||
| predicate were clarified | ||
| with plain English in the | ||
| proposed device | 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
- Sinus elevation & grafting of alveolar
sockets | The Strong Dental Handpieces are 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, preprosthesis
surgical modellation, sequestrotomia,
fenestration on the alveolar
appendix, apical ventilation, bone
modellation, bone smoothing.
• ACL-01C, ACL-02C and ACL(B)-01C
for the osteotomia on the upper and
lower jaw, germectomia,
sequestrotomia. |
| Parameter | Proposed | Predicate |
| | STRONG Dental Handpieces (Model Nos.: | STRONG Dental Handpieces (Model Nos.: |
| | ACL(B)-03C and ACL(B)-03F) | AT- II, ACL-01C, ACL-02C and ACL(B)-01C) |
| | 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 | 1:1 | 1:1 |
| Length | 83.7 mm | 84.0, 84.0, 83.6 mm |
| Diameter | Ø 19.6 | Ø 19.6 |
| Dia. of tool | 2.35, 1.60 mm | 2.35 mm |
| Max. Overall Length of | 30 mm | 45, 30, 30 mm |
| Rotary Instrument | | |
| Head Height | 13.7 mm | 13.7 mm |
| Head Diameter | Ø 8 mm | Ø 8, 10 mm |
| Shank | By ISO1797-1 | By ISO1797-1 |
| Length of Shank | 9 – 12 mm | 9 – 12 mm |
| Type of Chuck | Push-Button Locking | Latch or 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 | C3604BD-F/Hard Chrome Coated | C3604BD-F/Hard Chrome Coated |
| Chuck | SUS420F/Vacuum Heat Treatment | SUS420F/Vacuum Heat Treatment |
| Handle | AL6061/Anodizing | AL6061/Anodizing |
| Pipe | N/A | C3604BD-F |
| Patient-Contacting | Chuck, Head | Chuck, Head |
| Operator-Contacting | Handle, Head | Handle, Head |
| Technical Specification | | |
| Parameter | Proposed | Predicate |
| | STRONG Dental Handpieces (Model Nos.: | STRONG Dental Handpieces (Model Nos.: |
| | ACL(B)-03C and ACL(B)-03F) | AT- II, ACL-01C, ACL-02C and ACL(B)-01C) |
| Chuck Design | Type1 and Type 3 Push-Button Locking by
ISO 1797-1 | Type 2 by ISO 1797-1
Type1 Latch or Push-Button Locking by ISO
1797-1 |
| Bur Extraction Force(N)
Max. Torques
Max. Water Pressure
Max. Speed in rpm
Shank Conformance
Coupling Dimension | 45 N, 22N
50 Ncm
N/A
35,000 rpm
By ISO 1797-1
By ISO 3964 | 55 - 56 N
50 Ncm
N/A
30,000 - 35,000 rpm
By ISO 1797-1
By ISO 3964 |
| Lubricant
Chemical Composition
510k#
Biocompatible
Delivery system | N/A | DO-ALL Dental Handpiece Lubricant
K073353
N/A. Not intended for patient-contact
Spray Nozzel |
| Sterilization | Steam Heat 132 °C/4minutes | Steam Heat 134 °C/4minutes |
| Operating principle | The STRONG Dental Handpieces, ACL(B)- | The STRONG Dental Handpieces, AT- II, |
| | 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
with ISO 1797-1. They have contra angle
attachment for difficult to reach
areas | ACL-01C, ACL-02C and ACL(B)-01C, 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 with ISO 1797-1. They
have contra angle attachment for difficult to |
| Parameter | Proposed
STRONG Dental Handpieces (Model Nos.:
ACL(B)-03C and ACL(B)-03F) | Predicate
STRONG Dental Handpieces (Model Nos.:
AT- II, ACL-01C, ACL-02C and ACL(B)-01C) |
| | intended to prepare dental cavities for
restorations, such as fillings, and for cleaning
teeth. | reach areas intended to prepare dental
cavities for restorations, such as fillings, and
for cleaning teeth. |
8
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Image /page/11/Picture/0 description: The image shows the address and contact information for Saeshin. The address is #52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 711-814, Korea. The telephone number is +82 53 587 2341, and the fax number is +82 53 580 0999. The Saeshin logo is at the top of the image.
9. Summary of Non-Clinical Performance Data
● Biocompatibility
The materials contacting patients of chuck and the head were totally same and have been previously cleared by FDA through K100192 of predicate device, STRONG Dental Handpiece. The test report has been issued by Korea Testing & Research Institute, 7-6, Gomak-Ri, Wolgot-Myeon, Gimpo-Si, Gyunggi-Do, 415-871, Korea.
The categorization of contact was established under ISO 10993-1:2009-10-15.
According to the recommendations in this standard and FDA Blue Book Memo #G95-
- 1, the following tests are applicable and were performed:
- Cytotoxicity according to ISO 10993-5 -
- -Sensitization according to ISO 10993-10
- -Irritation or intracutaneous reactivity according to ISO 10993-10
● Bench Testing
Bench testing was performed to ensure the performance of the STRONG Dental Handpieces. ACL(B)-03C and ACL(B)-03F, verify conformity to ISO 14457 and demonstrate substantial equivalence to the predicates.
ACL(B)-03C and ACL(B)-03F samples were compliant with ISO 14457: 2012 Dentistry - Handbieces And Motors and demonstrated substantial equivalence to the predicates.
-Visual inspection of general design
This test was performed with normal visual and profile projector. All the articles comply with the acceptance criteria of Section 7.2 of the handpiece standard.
Extraction force -
The STRONG Dental Handpieces, ACL(B)-03C, for extraction test mandrel type 3 from the locking chuck system shall be at least 45N. In addition, STRONG Dental Handpieces, ACL(B)-03F, for extraction test mandrel type 5 from the locking chuck system shall be at least 22N. The results are reported in the table below:
| Article No. | Mean (N) |
|---|---|
| ACL(B)-03C | 51.2 N |
| ACL(B)-03F | 32.2 N |
Eccentricity -
The eccentricity of the test mandrel in rotation and without applied load shall not be exceeded the total indicated run-out of 0.08 mm. The results are reported in the table below
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Image /page/12/Picture/0 description: The image shows the logo for Saeshin. The logo consists of a geometric shape made up of several triangles in shades of blue, positioned above the company name, "SAESHIN," written in a bold, sans-serif font, also in blue. The geometric shape resembles a stylized cube or diamond, giving the logo a modern and technological feel.
| Article No. | Mean (mm) |
|---|---|
| ACL(B)-03C | 0.014 |
| ACL(B)-03F | 0.012 |
Resistance to sterilizing procedure -
After 250 cycles of 132 ° for 4 minutes in the autoclave, there was no sign of deterioration.
| Article No. | Deterioration
detected | Extraction
45 N, > 22
N | Max. speed
±10% rpm | Noise