(245 days)
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, osteoplasty
-
- Bone contouring & alveoplasty around living teeth
-
- Removal of exostosis
C. Bone grafting
- Removal of exostosis
-
- 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
- Sinus elevation & grafting of alveolar sockets
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 provided document describes a 510(k) premarket notification for the STRONG Dental Handpieces (models ACL(B)-03C and ACL(B)-03F). The intention is to demonstrate substantial equivalence to a predicate device (K100192).
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
Key Takeaway: This submission is for a medical device (dental handpieces), not for an AI/ML powered device. Therefore, many of the typical questions regarding AI/ML study design, such as information about training sets, test sets, ground truth establishment by experts, adjudication methods, and MRMC studies, are not applicable here. The evaluation focuses on non-clinical bench testing and biocompatibility to prove substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Test Standards based on ISO 14457) | STRONG Dental Handpieces (ACL(B)-03C) Performance | STRONG Dental Handpieces (ACL(B)-03F) Performance |
|---|---|---|
| Visual Inspection of General Design (Section 7.2 of handpiece standard) | Complies | Complies |
| Extraction Force (minimum) | ≥ 45 N | ≥ 22 N |
| Reported Extraction Force (Mean) | 51.2 N | 32.2 N |
| Eccentricity (maximum total indicated run-out) | ≤ 0.08 mm | ≤ 0.08 mm |
| Reported Eccentricity (Mean) | 0.014 mm | 0.012 mm |
| Resistance to Sterilizing Procedure (Deterioration) (after 250 cycles of 132°C for 4 min) | No deterioration detected | No deterioration detected |
| Resistance to Sterilizing Procedure (Extraction Force) (after 250 cycles) | > 45 N (Reported: 51.2 N) | > 22 N (Reported: 32.2 N) |
| Resistance to Sterilizing Procedure (Max. Speed) (±10% rpm from initial) | 35,000 rpm (Reported: 35,120 rpm) | 35,000 rpm (Reported: 35,090 rpm) |
| Resistance to Sterilizing Procedure (Noise) | < 70 dB (Reported: 55 dB) | < 70 dB (Reported: 54 dB) |
| Temperature Rise (max. at touchable surface, compared to environment) | ≤ 20°C (Reported: 10°C) | ≤ 20°C (Reported: 6°C) |
| Resistance to Corrosion (after 10 autoclave cycles at 132°C for 4 min, 22kPa) | No signs of corrosion | No signs of corrosion |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity) | Compliant (previously cleared via K100192) | Compliant (previously cleared via K100192) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact number of units or distinct samples for each bench test (e.g., how many handpieces were tested for extraction force or eccentricity). It refers to "ACL(B)-03C and ACL(B)-03F samples" which were compliant.
- Data Provenance: The tests are non-clinical bench tests performed by the manufacturer, Saeshin Precision Co., Ltd. The biocompatibility test report was issued by the Korea Testing & Research Institute. This data is retrospective in the sense that the tests were conducted prior to the 510(k) submission. The country of origin for the testing institution (Korea Testing & Research Institute) is Korea.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not Applicable. This is a physical medical device. "Ground truth" in the context of expert consensus is not relevant. The "ground truth" for the device's performance is established by adhering to recognized industry standards (e.g., ISO 14457, ISO 10993, ISO 17665-1) and performing objective physical measurements and analyses.
4. Adjudication Method for the Test Set
- Not Applicable. As this involves objective physical testing against predetermined standards, there is no expert adjudication process in the manner of diagnostic interpretation. The results are compared directly to the specified numerical or qualitative criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- Not Applicable. This device is a dental handpiece, not an AI/ML powered diagnostic or therapeutic device. No human-in-the-loop performance or reader studies are mentioned or relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- Not Applicable. This is not an algorithm or AI system.
7. The Type of Ground Truth Used
- For the non-clinical bench tests, the "ground truth" is adherence to international standards and specifications (e.g., ISO 14457 for dental handpieces, ISO 10993 for biocompatibility, ISO 17665-1 for sterilization). The performance of the device is directly measured against these established quantitative and qualitative criteria.
- For biocompatibility, the predicate device (K100192) having previously cleared the same materials is also cited as "ground truth" for material safety.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. Not an AI/ML device.
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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.
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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
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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)
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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
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- . 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
-
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- 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 |
| StandardCoupling | 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 Useare the same in thepredicate and proposeddevices, except that theterms used in thepredicate were clarifiedwith plain English in theproposed device | The Strong Dental Handpieces are indicatedfor wide range of dental procedures.A. Implant placement, including1. Preparation of the osteotomy site2. Bone contouring, osteoplastyB. Periodontal surgeries1. Bone contouring & alveoplastyaround living teeth2. Removal of exostosisC. Bone grafting1. Preparation of the donor site (for e.g.symphysis and ascending rames etc.)2. Harvesting autogen living bone3. Sinus elevation & grafting of alveolarsockets | The Strong Dental Handpieces are indicatedfor wide range of dental procedures.• AT- II for the application in the areaof the front teeth, root tip resection,bone removal, osteotomia on theupper and lower jaw, preprosthesissurgical modellation, sequestrotomia,fenestration on the alveolarappendix, apical ventilation, bonemodellation, bone smoothing.• ACL-01C, ACL-02C and ACL(B)-01Cfor the osteotomia on the upper andlower 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 byISO 1797-1 | Type 2 by ISO 1797-1Type1 Latch or Push-Button Locking by ISO1797-1 |
| Bur Extraction Force(N)Max. TorquesMax. Water PressureMax. Speed in rpmShank ConformanceCoupling Dimension | 45 N, 22N50 NcmN/A35,000 rpmBy ISO 1797-1By ISO 3964 | 55 - 56 N50 NcmN/A30,000 - 35,000 rpmBy ISO 1797-1By ISO 3964 |
| LubricantChemical Composition510k#BiocompatibleDelivery system | N/A | DO-ALL Dental Handpiece LubricantK073353N/A. Not intended for patient-contactSpray 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 adjustableelectrical motors for surgery treatment. It isattached to drive via ISO 3964 coupling. Thehead clamp accepts instrument complyingwith ISO 1797-1. They have contra angleattachment for difficult to reachareas | ACL-01C, ACL-02C and ACL(B)-01C, aregear driven hand-held dental handpieceswith gear ratio of 1:1. It can be driven bytorque adjustable electrical motors forsurgery treatment. It is attached to drive viaISO 3964 coupling. The head clamp acceptsinstrument complying with ISO 1797-1. Theyhave contra angle attachment for difficult to | |
| Parameter | ProposedSTRONG Dental Handpieces (Model Nos.:ACL(B)-03C and ACL(B)-03F) | PredicateSTRONG Dental Handpieces (Model Nos.:AT- II, ACL-01C, ACL-02C and ACL(B)-01C) |
| intended to prepare dental cavities forrestorations, such as fillings, and for cleaningteeth. | reach areas intended to prepare dentalcavities for restorations, such as fillings, andfor cleaning teeth. |
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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. | Deteriorationdetected | Extraction> 45 N, > 22N | Max. speed±10% rpm | Noise <70dB |
|---|---|---|---|---|
| ACL(B)-03C | No | 51.2 N | 35,120 | 55 |
| ACL(B)-03F | No | 32.2 N | 35,090 | 54 |
Temperature rise -
Rise of maximum temperature at the touchable surface of the housing under rated running conditions shall not exceed 20℃ compared to the temperature of the environment. The results are reported in the table below;
| Article No. | Mean (°C) |
|---|---|
| ACL(B)-03C | 10 |
| ACL(B)-03F | 6 |
-Resistance to corrosion
Handpieces are corrosion resistant. There was no signs of corrosion after having autoclave procedure 10 times at 132 ℃ for 4 minutes at 22kPa.
● 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.
. Sterilization
The STRONG Dental handpieces, ACL(B)-03C and ACL(B)-03F, is provided nonsterile and labeled for sterilization by the end user, the Instructions for use include the following parameters:
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Image /page/13/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, 711-814, Korea. The telephone number is +82 53 580 0925 and the fax number is +82 53 580 0939.
| Sterilization Type | Temperature | Time | LoadCharacteristics | Dry Time |
|---|---|---|---|---|
| Steam Sterilization(Pre-vacuumType) | 132 °C | 4 min. | Sterilization Bag | 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.
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.
In all the respects, the STRONG Dental Handpieces is the equivalent to currently marketed device.
§ 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.