(126 days)
HySil Heavy is to be used as heavy-bodied materials for:
- One-step impression technique (simultaneous technique) using single or dual viscosities
- Two-step impression technique using dual viscosities
- Functional impressions
HySil Mono is to be used as a medium-bodied tray or syringeable impression material for:
- Taking impressions over fixed/removable restorations and implants (i.e., transferring impression posts and bridge components)
- Functional impressions
- Fabricating crown and bridgework or inlays
- Fabricating full or partial dentures
- Reline impressions
- Use in the simultaneous mixing technique as well as the putty-wash and triple tray techniques
- Transferring root posts when fabricating posts and cores indirectly
HySil Bite is used for impression as below.
- Taking occlusal surfaces
- Confirming occlusal surfaces
- Recording after putting the articulator
HySil Impression materials are intended to be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums.
HySil Heavy and HySil Mono are addition-curing, elastomeric materials with hydrophilic property, high tear strength, dimensional accuracy, and a high resistance to permanent deformation. HySil Heavy and HySil Mono are available in an assortment of delivery systems of traditional 1:1 50 ml automix cartridge (predicated, K170736) and 5:1 380 ml automix cartridge version for use in most automatic dispensing and mixing system. HySil Heavy and HySil Mono are classified into Type 1 and Type 2 according to ISO 4823 each.
HySil Bite is an addition-curing silicone bite registration materials in a 50 ml cartridge type to measure accurate bite. HySil Bite is suitable for bite registration as it has a short setting time, high final hardness after curing for user convenience, and less elastic deformation when eliminated. HySil Bite is classified into jaw relation recording material according to DIN 13903.
The provided documents are a 510(k) Premarket Notification for a dental impression material named HySil Impression Materals (Heavy, Mono, and Bite). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study in the way an AI/ML device would.
Therefore, many of the requested categories related to AI/ML device studies (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, and how training ground truth was established) are not applicable to this submission.
However, I can still extract the acceptance criteria as described in the benchmark standards and the reported performance (which is that it passed these criteria).
Here's the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Standard | Reported Device Performance |
|---|---|---|
| HySil Heavy & Mono | ||
| Visual | ISO 4823 | Passed requirements |
| Weight | ISO 4823 | Passed requirements |
| Package | ISO 4823 | Passed requirements |
| Component Color | ISO 4823 | Passed requirements |
| Consistency | ISO 4823 | Passed requirements |
| Detail Reproduction | ISO 4823 | Passed requirements |
| Compatibility with Gypsum | ISO 4823 | Passed requirements |
| Linear Dimensional Change | ISO 4823 | Passed requirements |
| Elastic Recovery | ISO 4823 | Passed requirements |
| Strain-in-Compression | ISO 4823 | Passed requirements |
| Working Time | ISO 4823 | Passed requirements |
| HySil Bite | ||
| Working Time (Longer than 15s) | DIN 13903 | Passed requirements (≥ 30 seconds) |
| Physical Tests | DIN 13903 | Passed criteria |
| Biocompatibility | ||
| Cytotoxicity | ISO 10993-5 | Assured biological safety |
| Skin Sensitization | ISO 10993-10 | Assured biological safety |
| Oral Mucosa Irritation | ISO 10993-10 | Assured biological safety |
| Acute Systemic Injection | ISO 10993-11 | Assured biological safety |
| Shelf Life | Real-time shelf-life tests | 2 years (HySil Heavy/Mono), 3 years (HySil Bite) |
2. Sample size used for the test set and the data provenance
This is a material science and biocompatibility study, not a clinical trial or AI/ML study. Sample sizes for the bench tests are generally defined by the relevant ISO/DIN standards, but specific numbers are not provided in this summary. Data provenance is implied to be from laboratory testing conducted by the manufacturer (OSSTEM IMPLANT Co., Ltd.) for the purpose of this submission. The tests are retrospective as they were conducted prior to the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for material properties testing is based on objective measurements and adherence to international standards (ISO and DIN), not expert consensus in the diagnostic sense. Biocompatibility results are interpreted by qualified toxicologists/biologists according to ISO standards.
4. Adjudication method for the test set
Not applicable. Test results are based on objective measurement against predefined standard criteria, not human adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The ground truth for the performance claims (mechanical properties, biocompatibility, shelf life) is based on:
* Objective Measurements: Laboratory measurements of physical and chemical properties of the material.
* International Standards: Adherence to the requirements specified in ISO 4823 (for HySil Heavy and Mono) and DIN 13903 (for HySil Bite).
* Biocompatibility Standards: Compliance with ISO 10993-5, 10993-10, and 10993-11.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services, featuring a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" in blue text next to and below it.
Osstem Implant Co., Ltd. % David Kim Manager Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030 September 13, 2018
Re: K181236
Trade/Device Name: HySil Impression Materials (Heavy, Mono, and Bite) Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: June 26, 2018 Received: June 26, 2018
Dear David Kim:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
{1}------------------------------------------------
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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
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510(k) Number K_181236
Device Name: HySil Impression Materials
Indication for Use:
HySil Heavy is to be used as heavy-bodied materials for:
- One-step impression technique (simultaneous technique) using single or dual viscosities -
- Two-step impression technique using dual viscosities -
- -Functional impressions
HySil Mono is to be used as a medium-bodied tray or syringeable impression material for:
- Taking impressions over fixed/removable restorations and implants -(i.e., transferring impression posts and bridge components)
- -Functional impressions
- Fabricating crown and bridgework or inlays -
- Fabricating full or partial dentures -
- Reline impressions -
- -Use in the simultaneous mixing technique as well as the putty-wash and triple tray techniques
- -Transferring root posts when fabricating posts and cores indirectly
HySil Bite is used for impression as below.
- Taking occlusal surfaces -
- Confirming occlusal surfaces -
- -Recording after putting the articulator
Prescription Use X (Per 21CFR801 Subpart D) OR Over-The-Counter Use (Per 21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary
Date: April 27, 2018
1. Company and Correspondent making the submission
| - Submitter's Name | : OSSTEM IMPLANT Co., Ltd. |
|---|---|
| - Address | : 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan612-070, Republic of Korea |
| - Contact | : Ms. Jungmin Yoo |
| - Phone | : +82-51-850-2575 |
| - Correspondent's Name | : HIOSSEN Inc. |
| - Address | : 85 Ben Fairless Dr. Fairless Hills, PA 19030 |
| - Contact | : Mr. David Kim |
| - Phone | : 267-759-7031 |
2. Device
| - Trade or (Proprietary) Name | : HySil Impression Material |
|---|---|
| - Classification Name | : Impression Material |
| - Regulation Number | : 21CFR872.3660 |
| - Devce Classification | : Class II |
| - Classification Product Code | : ELW |
3. Predicate Device
Primary Predicate -HySil Impression Materials, OSSTEM IMPLANT Co., Ltd. (K170736)
4. Description
HySil Impression materials are intended to be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums.
HySil Heavy and HySil Mono are addition-curing, elastomeric materials with hydrophilic property, high tear strength, dimensional accuracy, and a high resistance to permanent deformation. HySil Heavy and HySil Mono are available in an assortment of delivery systems of traditional 1:1 50 ml automix cartridge (predicated, K170736) and 5:1 380 ml automix cartridge version for use in most automatic dispensing and mixing system. HySil Heavy and HySil Mono are classified into Type 1 and Type 2 according to ISO 4823 each.
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Image /page/4/Picture/1 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The address is 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea. The telephone number is +82 51 850-2500, the fax number is +82 51 850-4341, and the website address is www.osstem.com.
HySil Bite is an addition-curing silicone bite registration materials in a 50 ml cartridge type to measure accurate bite. HySil Bite is suitable for bite registration as it has a short setting time, high final hardness after curing for user convenience, and less elastic deformation when eliminated. HySil Bite is classified into jaw relation recording material according to DIN 13903.
-
- Substantial Equivalence Matrixes
- HySil Heavy and HySil Mono (Addition in 5:1 380 ml automix cartridge version) -
| Proposed Devices | Predicated Devices | Remark | |
|---|---|---|---|
| 510(k) No. | Proposed | K170736 | |
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Same |
| Indicationsfor Use | HySil Heavy is to be used asheavy-bodied materials for:- One-step impressiontechnique (simultaneoustechnique) using single ordual viscosities- Two-step impressiontechnique using dualviscosities- Functional impressionsHySil Mono is to be used as amedium-bodied tray orsyringeable impressionmaterial for:- Taking impressions overfixed/removablerestorations and implants(i.e., transferringimpression posts andbridge components)- Functional impressions- Fabricating crown andbridgework or inlays- Fabricating full or partialdentures- Reline impressions- Use in the simultaneousmixing technique as wellas the putty-wash andtriple tray techniques- Transferring root postswhen fabricating posts | HySil Heavy is to be used asheavy-bodied materials for:- One-step impressiontechnique (simultaneoustechnique) using single ordual viscosities- Two-step impressiontechnique using dualviscosities- Functional impressionsHySil Mono is to be used as amedium-bodied tray orsyringeable impressionmaterial for:- Taking impressions overfixed/removablerestorations and implants(i.e., transferringimpression posts andbridge components)- Functional impressions- Fabricating crown andbridgework or inlays- Fabricating full or partialdentures- Reline impressions- Use in the simultaneousmixing technique as wellas the putty-wash andtriple tray techniques- Transferring root postswhen fabricating posts | Same |
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Image /page/5/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in orange, with a small superscript "6" next to the "M". Below "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and modern.
OSSTEM Implant Co., Ltd
Section 8
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
| Descriptionof Material | Vinylpolysiloxane | Vinylpolysiloxane | Composedwith sameaffiliatedmaterials, butratios of eachcomponent inuse areslightlydifferent |
|---|---|---|---|
| StandardConformed | ISO 4823 | ISO 4823 | Same |
| Shelf Life | 2 years | 2 years | Same |
| S.E. | Similarities:The proposed devices and the predicated devices have same indications for use andhave same shelf life of 2 years. They are all conformed to the ISO 4823 standard;also, both products are composed with same affiliated material calledVinylpolysiloxane. Therefore, the results of the performance testing and theircomposition are substantially equivalent.Differences:Compared to the predicated devices, the proposed devices don't have L-menthol intheir composition. The ratios of each component or kinds of pigments of thematerials in use are slightly different. However, based on the results of theperformance and the biocompatibility testing, the subject and the predicate devicepassed the requirements.. Therefore, we state that proposed devices (HySil Heavy and Mono, 5:1 380 ml automix cartridge) are substantially equivalent to the predicated devices (HySil |
- HySil Bite (Change in guidance of working time only) -
| Proposed Devices | Predicated Devices | Remark | |
|---|---|---|---|
| 510(k) No. | Proposed | K170736 | - |
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Same |
| Indicationsfor Use | HySil Bite is used forimpression as below.- Taking occlusal surfaces- Confirming occlusalsurfaces- Recording after puttingthe articulator | HySil Bite is used forimpression as below.- Taking occlusal surfaces- Confirming occlusalsurfaces- Recording after puttingthe articulator | Same |
| WorkingTime | 30 seconds or more | 15 seconds or more | Different |
| Descriptionof Material | Vinylpolysiloxane | Vinylpolysiloxane | Same |
| StandardConformed | DIN 13903 | DIN 13903 | Same |
| Shelf Life | 3 years | 3 years | Same |
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Image /page/6/Picture/1 description: The image shows the logo for Osstem Implant. The logo is orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. There is a small superscript "6" next to the word "OSSTEM".
Bansong-ro 513beon-gil u Busan Republic of Korea 82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
| S.E. | Similarities:The proposed device and the predicated device have same indications for use andhave same shelf life of 3 years. They are all conformed to the DIN 13903 standard;also, both products are composed with same affiliated material calledVinylpolysiloxane.Differences:The working time (processing time) of device is guided by the manufacturer. Theworking time of the proposed device is 30 seconds or more while the predicateddevice is 15 seconds or more. Physical test for changing guidance of working timewas conducted and it passed the criteria of DIN 13903 standard.: . Therefore, we state that propose device is substantially equivalent to thepredicated device cleared in K170736. |
|---|---|
| ------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
-
- Indication for Use
HySil Heavy is to be used as heavy-bodied materials for:
- Indication for Use
-
One-step impression technique (simultaneous technique) using single or dual viscosities
-
-Two-step impression technique using dual viscosities
-
-Functional impressions
HySil Mono is to be used as a medium-bodied tray or syringeable impression material for:
- Taking impressions over fixed/removable restorations and implants -(i.e., transferring impression posts and bridge components)
- Functional impressions -
- Fabricating crown and bridgework or inlays -
- -Fabricating full or partial dentures
- -Reline impressions
- Use in the simultaneous mixing technique as well as the putty-wash and triple tray techniques
- Transferring root posts when fabricating posts and cores indirectly -
HySil Bite is used for impression as below.
- Taking occlusal surfaces -
- -Confirming occlusal surfaces
- -Recording after putting the articulator
-
- Summary of Non-Clinical Performance Testing
Non-clinical testing data are submitted, referenced, or relied upon to demonstrate substantial equivalence.
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Image /page/7/Picture/1 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The address is 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea. The telephone number is +82 51 850-2500, the fax number is +82 51 850-4341, and the website address is www.osstem.com.
Biocompatibility evaluation
Biocompatibility tests including cytotoxicity, skin sensitization, oral mucosa irritation, and acute systemic injection have been performed to assure biological safety in accordance with ISO 10993-5, 10993-10, and 10993-11.
Sterilization Validation and Shelf-life
All subject devices in HySil Impression materials are delivered in non-sterile. Therefore, sterilization vas not considered. For the shelf-life of subject devices, we conducted real-time shelf-life tests and leveraged the data that of our prior submissions.
Mechanical Properties
Bench tests evaluated for HySil Impression Materials included visual, weight, package, component color, consistency, detail reproduction, compatibility with gypsum, linear dimensional change, elastic recovery, strain-in-compression, and working time in accordance with ISO 4823 and DIN 13903. Mechanical properties from bench tests of HySil Impression Materials found substantially equivalent to the predicate devices.
-
- Summary of Clinical Testing
No clinical studies are submitted.
- Summary of Clinical Testing
-
- Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification. OSSTEM IMPLANT Co., Ltd. concludes that the HySil Impression Materials are substantially equivalent to the predicated devices as herein.
- Conclusion
§ 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).