(94 days)
- Impression material in a dual phase impression technique
- Precise duplication of models
- Capturing multiple unit impressions
i-Sil is impression material. It has 5 types: Heavy, Medium, Light, Putty and Bite.
The i-Sil dental impression material has been determined to be substantially equivalent to the predicate device K152766 (Dentkist, Inc.'s CharmFlex products) based on performance data gathered through bench testing, outlined in the 510(k) Summary.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents performance data for the i-Sil device and compares it to the predicate device across various types (Heavy body, Medium body, Light body, Putty, Bite). The acceptance criteria are implicitly defined by the properties and values reported for both the subject and predicate devices, largely referencing ISO 4823 standards for elastomeric impression materials where applicable.
Heavy Body, Medium Body, Light Body Types:
| Test Item | Standard/Predicate Performance (Acceptance Criteria) | i-Sil Performance (Reported Device Performance) |
|---|---|---|
| Appearance | ISO 4823 Dentistry-Elastomeric impression materials | (implicitly meets standard) |
| Weight | ISO 4823 Dentistry-Elastomeric impression materials | (implicitly meets standard) |
| Component | ISO 4823 Dentistry-Elastomeric impression materials | (implicitly meets standard) |
| Working time (Predicate) | 1'30" (cartridge), 2' (tube), 2'~2'30" (others) | Heavy: 1'36", Medium: 1'59", Light: 1'21" |
| Minimum strength | ISO 4823 Dentistry-Elastomeric impression materials | (implicitly meets standard) |
| Hardness | ISO 4823 Dentistry-Elastomeric impression materials | (implicitly meets standard) |
| Linear dimensional change (Predicate) | -0.063 % (for Heavy/Medium/Light) | Heavy: 0.18 %, Medium: 0.20 %, Light: 0.15 % |
| Consistency (Predicate) | 34.25 mm | Heavy: 33.83 mm, Medium: 34.83 mm, Light: 45.33 mm |
| Detail reproduction (Predicate) | 20 µm | Heavy: Pass, Medium: Pass, Light: Pass |
| Compatibility with gypsum (Predicate) | 20 µm | Heavy: Pass, Medium: Pass, Light: Pass |
| Elastic recovery (Predicate) | 99.67 % | Heavy: 99.64 %, Medium: 99.6 %, Light: 99.58 % |
| Strain-in-compression (Predicate) | 4.12 % | Heavy: 2.34 %, Medium: 3.29 %, Light: 4.94 % |
| Mixing time (Predicate) | 2'~4' | Heavy: 22.6", Medium: 38", Light: 26.8" |
| Flow properties (Predicate) | Low viscosity | Low viscosity |
| Keeping qualities (Predicate) | Cool and dry place (18 | Cool and dry place (18 |
Putty Type:
| Test Item | Standard/Predicate Performance (Acceptance Criteria) | i-Sil Performance (Reported Device Performance) |
|---|---|---|
| Mixing time (Predicate) | 30"~40" | 41" |
| Consistency (Predicate) | 25.83 mm | 31.75 mm |
| Detail reproduction (Predicate) | Pass | Pass |
| Linear dimensional change (Predicate) | -0.213 % | 0.35 % |
| Compatibility with gypsum (Predicate) | Pass | Pass |
| Elastic recovery (Predicate) | 99.75 % | 99.01 % |
| Strain-in-compression (Predicate) | 3.28 % | 3.26 % |
| Flow properties (Predicate) | High viscosity | High viscosity |
| Keeping qualities (Predicate) | Cool and dry place (18 | Cool and dry place (18 |
Bite Type:
| Test Item | Standard/Predicate Performance (Acceptance Criteria) | i-Sil Performance (Reported Device Performance) |
|---|---|---|
| Working time (Predicate) | 15" ↑ | 30" ↑ |
| Flexural strength (Predicate) | Pass | Pass |
| Hardness (Predicate) | Pass | 87.4 HD |
| Linear dimensional change (Predicate) | Pass | 0.064 % |
| Safety (Predicate) | Safe | Safe |
| Keeping qualities (Predicate) | Cool and dry place (18 | Cool and dry place (18 |
| Curve of the shrinkage (Predicate) | Brittle feature | Brittle feature |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "Bench test" data. It does not explicitly state the sample sizes used for each test. The data provenance is not explicitly mentioned as retrospective or prospective, but bench tests are typically conducted in a controlled laboratory environment. The company, SPIDENT Co.,Ltd., is located in Incheon, Korea, suggesting the bench testing may have been conducted there.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This is a materials science bench test, not a clinical study involving human assessment of images or diagnoses. Therefore, there are no "experts" in the sense of clinicians establishing ground truth. The "ground truth" for these tests is based on the adherence to objective physical and chemical properties as defined by the ISO 4823 standard and comparison to the predicate device's reported characteristics.
4. Adjudication Method for the Test Set:
Not applicable. This is not a study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No. This is a bench test for a dental impression material, not a diagnostic imaging device that would involve MRMC studies or human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
No. This terminology applies to AI/software as a medical device (SaMD), not to a physical impression material.
7. The Type of Ground Truth Used:
The ground truth used for these bench tests is derived from:
- ISO 4823 Dentistry-Elastomeric impression materials standard: This standard defines the methodologies and acceptable ranges for various physical and chemical properties of impression materials.
- Predicate device performance data: The reported performance characteristics of the legally marketed predicate device (K152766, CharmFlex products) serve as a comparative benchmark to demonstrate substantial equivalence.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical impression material, not an artificial intelligence or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 30, 2016
Spident Co., Ltd. % Mark Choi President Spident Usa Inc. 2115 Linwood Ave, 5f, Fort Lee, New Jersey 07024
Re: K161774
Trade/Device Name: I-Sil Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: June 8, 2016 Received: June 28, 2016
Dear Mark Choi:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
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 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/ResourcesforYou/Industry/default.htm. 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.
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,
Susan Runno, DDS, MA
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name i-Sil
Indications for Use (Describe)
- Impression material in a dual phase impression technique
- Precise duplication of models
- Capturing multiple unit impressions
Type of Use (Select one or both, as applicable)
الص 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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510(k) Summarv
[as required by 807.92(c)]
1. Applicant
-
- Company : SPIDENT Co.,Ltd.
-
- Address : 203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu, Incheon, Korea
-
- Tel : 82-32-819-4570
-
- Fax : 82-32-819-4572
-
- Prepared date : Jun. 8, 2016
-
- Contact person : Mark Choi, Tel 201-944-0511
-
- Contact person address : 2115 Linwood Ave, 5F, Fort Lee, NJ 07024, U.S.A
-
- Submission date : Jul. 5, 2016
2. Device Information
-
- Trade name : i-Sil
-
- Common name : Dental Impression Materials
-
- Classification name : Material, Impression
-
- Product code : ELW
-
- Regulation number : 872.3660
-
- Class of device : Class II
-
- Panel : Dental
-
- Model codes : 13 model codes including i-Sil Heavy body fast
- i-Sil Heavy body fast -
- i-Sil Heavy body reqular
- i-Sil Heavy body jumbo -
- i-Sil Heavy body monophase
- i-Sil Medium body fast -
- i-Sil Medium body regular -
- i-Sil Medium body jumbo
- i-Sil Medium body denture -
- i-Sil Light body fast -
- i-Sil Light body regular -
- i-Sil Putty fast -
- i-Sil Putty regular -
- i-Sil Bite -
3. The legally marketed device to which we are claiming equivalence
K152766, Dentkist, Inc
4. Device description
i-Sil is impression material. It has 5 types: Heavy, Medium, Light, Putty and Bite.
5. Intended Use :
- Impression material in a dual phase impression technique
- Precise duplication of models
- Capturing multiple unit impressions
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6. Performance data:
Bench test
| Test items | Standards |
|---|---|
| Appearance test | ISO 4823 Dentistry-Elastomeric impressionmaterials |
| Weight test | |
| Component test | |
| Working time test | |
| Minimum strength test | |
| Hardness test | |
| Linear dimensional change test | |
| Consistency | |
| Working time | |
| Detail reproduction | |
| Compatibility with gypsum | |
| Elastic recovery | |
| Strain-in-compression |
7. Predicate device comparison table
- Heavy body, Medium body and Light body
| Subject Device | Predicate Device | |
|---|---|---|
| Company | SPIDENT Co.,Ltd. | Dentkist, Inc. |
| Device Name | i-Sil Heavy body fast/i-Sil Heavy bodyregular/i-Sil Heavy body jumbo/i-SilHeavy body monophase/i-Sil Mediumbody fast/i-Sil Medium body regular/i-SilMedium body jumbo/i-Sil Medium bodydenture/i-Sil Light body fast/i-Sil Lightbody regular | CharmFlex Heavy / CharmFlex Regular /CharmFlex Denture / CharmFlex Light LV /CharmFlex Light XLV / CharmFlex Light Premium |
| 510(k) # | N/A | K152766 |
| Classification | Material, Impression | Material, Impression |
| Product Code | ELW | ELW |
| Regulation | 21 CER 872.3660 | 21 CER 872.3660 |
| Intended Use | - Impression material in a dual phaseimpression technique- Precise duplication of models- Capturing multiple unit impressions | - Impression material in a dual phase impressiontechnique- Precise duplication of models- Capturing multiple unit impressions |
| Method ofmanipulation | 1. Heavy bodyCartridge type :1)Apply Heavy-body on the tray.2) Inject Light-body on tray and directly ontothe teeth. ( Intra oral tip is used to injectaround the teeth.)3) Set the tray in the mouth, keep thematerial until it is perfectly set in mouth.4) After impression material is perfectly set.store it in room for 30 minutes.2. Medium body, Light body1) Apply the materials onto the tray of putty(2-step) / Heavy Body (1-step)depending on techniques being used.2) Set the tray in the mouth, keep thematerial until it is perfectly set in mouth.3) After impression material is perfectly set,store it in room for 30 minutes. | 1. CharmFlex Heavy1) Tube type: Squeeze equal volume of Base andCatalyst (1:1) and mix quickly with a tool for within1'30" and load Heavy-body on the tray.Cartridge type : Apply Heavy-body on the tray.2) Inject Light-body on tray and directly onto the teeth.( Intra oral tip is used to inject around the teeth.)3) Set the tray in the mouth, keep the material until it isperfectly set in mouth.4) After impression material is perfectly set, store it inroom for 30 minutes.2. CharmFlex Regular / CharmFlex Denture / CharmFlexLight LV / CharmFlex Light XLV / CharmFlex LightPremium1) Apply the materials onto the tray of putty (2-step) /Heavy Body (1-step) depending on techniquesbeing used.2) Set the tray in the mouth, keep the material until it isperfectly set in mouth.3) After impression material is perfectly set, store it inroom for 30 minutes. |
| Chemical composition | - Siloxane vinyl terminated- Siloxane hydride terminated- Surfactant- Silica- Pigments | - Vinyl Siloxane- Hydrogen Siloxane- Silicon dioxide- Calcium silicate- Mineral Oil- Pigments |
| Flow properties | Low viscosity | Low viscosity, Heavy(high viscosity) |
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| Working time | 1. i-Sil Heavy body series : 1'36"2. i-Sil Medium body seris : 1'59"3. i-Sil Light body series : 1'21" | 1.CharmFlex Heavy cartridge type: 1'30"2.CharmFlex Heavy tube type: 2'3.CharmFlex Regular/CharmFlexDenture/CharmFlex Light LV/CharmFlex LightXLV/CharmFlex Light Premium: 2'~2'30" |
|---|---|---|
| Mixing time test | 1. i-Sil Heavy body series : 22.6"2. i-Sil Medium body series : 38"3. i-Sil Light body series : 26.8 " | 2'~4' |
| Consistency test report | 1. i-Sil Heavy body series : 33.83 mm2. i-Sil Medium body series : 34.83 mm3. i-Sil Light body series : 45.33 mm | 34.25mm |
| Detail reproduction | 1. i-Sil Heavy body series : pass2. i-Sil Medium body series : pass3. i-Sil Light body series : pass | 20 $ μ $ m |
| Linear dimensionalchange | 1. i-Sil Heavy body series : 0.18 %2. i-Sil Medium body series : 0.20 %3. i-Sil Light body series : 0.15 % | -0.063 % |
| Compatibility withgypsum | 1. i-Sil Heavy body series : pass2. i-Sil Medium body series : pass3. i-Sil Light body series : pass | 20 $ μ $ m |
| Elastic recovery | 1. i-Sil Heavy body series : 99.64 %2. i-Sil Medium body series : 99.6 %3. i-Sil Light body series : 99.58 % | 99.67 % |
| Strain-in-compression | 1. i-Sil Heavy body series : 2.34 %2. i-Sil Medium body series : 3.29 %3. i-Sil Light body series : 4.94 % | 4.12 % |
| Keeping qualities | cool and dry place (18 | cool and dry place (18 |
| Curve of the shrinkage | No data | No data |
| Use | Dentist, Dental specialist | Dentist, Dental specialist |
2) Putty
| Subject Device | Predicate Device | |
|---|---|---|
| Company | SPIDENT Co.,Ltd. | Dentkist, Inc. |
| Device Name | i-Sil Putty fasti-Sil Putty regular | CharmFlex Putty / CharmFlex Putty Green /CharmFlex Putty Soft |
| 510(k) | N/A | K152766 |
| Classification | Material, Impression | Material, Impression |
| Product Code | ELW | ELW |
| Regulation | 21 CER 872.3660 | 21 CER 872.3660 |
| Intended Use | - Impression material in a dual phaseimpression technique- Precise duplication of models- Capturing multiple unit impressions | - Impression material in a dual phase impressiontechnique- Precise duplication of models- Capturing multiple unit impressions |
| Method ofmanipulation | 1. Take out the same amount of Base andCatalyst. (1:1 vol.)2. Knead them properly with hands until amixed color is attained. Wear disposable vinylgloves to prevent your hands from incurring anallergic reaction.3. Apply the mixed material to the tray and setinto the mouth.4. After the material is perfectly set, removefrom the mouth.5. Set the tray with Light-body on thecompleted Putty-body into the mouth.6. After the material is perfectly set, store it inroom for 30 minutes. | 1. Take out the same amount of Base and Catalyst. (1:1vol.)2. Knead them properly with hands until amixed color is attained. Wear disposable vinylgloves to prevent your hands from incurring anallergic reaction.3. Apply the mixed material to the tray and set into themouth.4. After the material is perfectly set, remove from themouth.5. Set the tray with Light-body on the completed Putty-body into the mouth.6. After the material is perfectly set, store it in room for30 minutes. |
| Chemical composition | - Siloxane vinyl terminated- Siloxane hydride terminated- Surfactant- Silica- Pigments | -Polyvinyl siloxane-Silica |
| Flow properties | High viscosity | High viscosity |
| Mixing time test | i-Sil Putty fast, i-Sil Putty regular: 41" | 30"~40" |
| Consistency test | i-Sil Putty fast, i-Sil Putty regular: 31.75mm | 25.83 mm |
| report | mm |
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| Detail reproduction | i-Sil Putty fast, i-Sil Putty regular: pass | pass |
|---|---|---|
| Linear dimensionalchange | i-Sil Putty fast, i-Sil Putty regular: 0.35 % | -0.213 % |
| Compatibility withgypsum | i-Sil Putty fast, i-Sil Putty regular: pass | pass |
| Elastic recovery | i-Sil Putty fast, i-Sil Putty regular:99.01 % | 99.75 % |
| Strain-in-compression | i-Sil Putty fast, i-Sil Putty regular: 3.26 % | 3.28 % |
| Keeping qualities | cool and dry place (18 | cool and dry place (18 |
| Curve of theshrinkage | No data | No data |
| Use | Dentist, Dental specialist | Dentist, Dental specialist |
3) Bite
| Subject Device | Predicate Device | |
|---|---|---|
| Company | SPIDENT Co.,Ltd. | Dentkist, Inc. |
| Device Name | CharmFlex Bite / CharmFlex Bite Clear / | |
| I-Sil Bite | CharmFlex Bite Fast | |
| 510(k) | N/A | K152766 |
| Classification | Material, Impression | Material, Impression |
| Product Code | ELW | ELW |
| Regulation | 21 CER 872.3660 | 21 CER 872.3660 |
| Intended Use | - Impression material in a dual phaseimpression technique- Precise duplication of models- Capturing multiple unit impressions | - Impression material in a dual phase impressiontechnique- Precise duplication of models- Capturing multiple unit impressions |
| Method ofmanipulation | 1. Check the expiration date and avoidpackage contamination.2. Follow the instructions for use before using.3. Place a disposable mixing tip on cartridge,and place the cartridge on exclusive mixinggun.4. Check to be made to mix well duringextrusion through the tips.5. Apply bite registration material directly ontothe occlusal surfaces.6. Set this material to intraoral until the impressionmaterial completely polymerized.7. Remove the set bite registration fromintraoral.8. Make a master cast with a instrument suchas a dental knife. | 1. Check the expiration date and avoid packagecontamination.2. Follow the instructions for use before using.3. Place a disposable mixing tip on cartridge, and placethe cartridge on exclusive mixing gun.4. Check to be made to mix well during extrusionthrough the tips.5. Apply bite registration material directly onto theocclusal surfaces.6. Set this material to intraoral until the impression materialcompletely polymerized.7. Remove the set bite registration from intraoral.8. Make a master cast with a instrument such as adental knife. |
| Chemical composition | - Siloxane vinyl terminated- Siloxane hydride terminated- Surfactant- Silica- Pigments | - Polyvinyl siloxane- Silica |
| Working time | 30" ↑ | 15" ↑ |
| Flexural strength | pass | pass |
| Hardness | 87.4 HD | pass |
| Linear dimensionalchange | 0.064 % | pass |
| Safety | safe | safe |
| Keeping qualities | cool and dry place (18 | cool and dry place (18 |
| Curve of theshrinkage | brittle feature | brittle feature |
| Use | Dentist, Dental specialist | Dentist, Dental specialist |
9. Conclusion:
The Device is investigated for substantially equivalent in intended use and technological characteristics to predicate device.
Comparison results demonstrate that the specifications and performance of the device are same as functional and effective as the legally marketed predicate device.
Therefore, it is concluded that I-Sil is substantially equivalent to the legally marketed predicate device.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).