(104 days)
HySil Heavy Super Fast 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 Super Fast 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 Light Super Fast is to be used as syringeable impression materials for:
- Two-step putty-wash impression technique
- One-step putty-wash impression technique
- Two-step impression technique using dual viscosities
- Reline impressions
- Fabricating full or partial dentures
HySil Super Fast Impression Materials are addition-curing, elastomeric materials with hydrophilic property. They 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 Super Fast Impression Materials meet ISO 4823 standard and consist of three different viscosities (heavy-bodied, medium-bodied, and light-bodied) in delivery system as standard 1:1 50 ml cartridges.
This document is a 510(k) Pre-Market Notification from Osstem Implant Co., Ltd. for their HySil Super Fast Impression Materials. The purpose of the submission is to demonstrate substantial equivalence to a legally marketed predicate device (HySil Impression Materials, K170736).
Based on the provided text, the device is HySil Super Fast Impression Materials (Heavy, Mono, Light viscoisties).
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the proposed devices meet the ISO 4823 standard. This standard dictates various mechanical and physical properties for elastomeric impression materials. The "Acceptance Criteria" are implied by adherence to this standard and the predicate device's performance.
| Acceptance Criteria (Implied by ISO 4823 and Substantial Equivalence Goal) | Reported Device Performance (HySil Super Fast Impression Materials) |
|---|---|
| Compliance with ISO 4823 Standard for Impression Materials | The proposed devices meet ISO 4823 standard |
| Biocompatibility (following ISO 10993-1) | Passed biocompatibility requirements |
| Shelf-life of 2 years | Determined shelf-life is 2 years |
| Mechanical Properties equivalent to predicate device | Found to be substantially equivalent to predicate devices from bench test results |
| Working Time over 1 min 15 sec. | Over 1 min. 15 sec. |
| Composition: Vinylpolysiloxane | Vinylpolysiloxane |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the test set used in the non-clinical performance evaluations (biocompatibility, shelf-life, mechanical properties).
The data provenance is not explicitly stated as "country of origin." However, the submitter, Osstem Implant Co., Ltd., is based in Busan, Republic of Korea. The studies are non-clinical, meaning they are laboratory or bench tests, not clinical trials on human subjects. Therefore, the data is retrospective in the sense that it's generated from lab tests, not from ongoing patient recruitment.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the studies described are non-clinical (bench tests) focusing on material properties rather than diagnostic performance or human interpretation. Therefore, there's no "ground truth" to be established by experts in the context of interpretation, nor are there experts evaluating the test results in a human-in-the-loop scenario. The ISO standards themselves define the "ground truth" for material properties.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (like 2+1, 3+1) is typically associated with clinical studies where multiple human readers interpret data, and their disagreements need to be resolved to establish ground truth.
Since the studies described are non-clinical bench tests (biocompatibility, shelf-life, mechanical properties against ISO standards), an adjudication method is not applicable. The outcome of these tests is usually objective measurement against predefined criteria in the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies are submitted."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is an impression material, not an algorithm or AI software. Therefore, the concept of a "standalone" or "algorithm only" performance study is not applicable.
7. The Type of Ground Truth Used
The ground truth for the non-clinical performance tests is based on established international standards:
- ISO 4823: For various mechanical and physical properties of elastomeric impression materials.
- ISO 10993-1: For biocompatibility evaluation.
- ISO 3417: Likely related to some aspect of impression material testing, though not explicitly detailed.
- "FDA Guidance Document Use of International Standard ISO 10993-1" and "FDA Guidance Document Shelf Life of Medical Device."
These standards define the objective criteria and methodologies for assessing the material's properties.
8. The Sample Size for the Training Set
This document describes a non-clinical evaluation for substantial equivalence of an impression material. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of device, this point is not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
January 30, 2020
Osstem Implant Co., Ltd. % Peter Lee QA/RA Manager Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030
Re: K192941
Trade/Device Name: HySil Super Fast Impression Materials Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: November 4, 2019 Received: November 5, 2019
Dear Peter Lee:
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
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas "Nandu" Nandkumar Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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510(k) Number: K192941
Device Name: HySil Super Fast Impression Materials
Indications for Use:
HySil Heavy Super Fast 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 Super Fast 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 impressi on 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 Light Super Fast is to be used as syringeable impression materials for:
- Two-step putty-wash impression technique -
- One-step putty-wash impression technique -
- Two-step impression technique using dual viscosities -
- Reline impressions -
- Fabricating full or partial dentures -
X
Prescription Use (21 CFR 801 Subpart D)
Over-The Counter Use (21 CFR 801 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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Osstem Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
510(k) Summary
Date: January 29, 2020
1. Company and Correspondent making the submission
| - | Submitter's Name | : Osstem Implant Co., Ltd. |
|---|---|---|
| - | Address | : 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan48002, Republic of Korea |
| - | Contact | : Ms. Jungmin Yoo |
| - | Phone | : +82-51-850-2500 |
| - | Correspondent's Name | : Hiossen Inc. |
| - | Address | : 85 Ben Fairless Dr. Fairless Hills, PA 19030 |
| - | Contact | : Mr. Peter Lee |
| - | Phone | : +1-267-759-7031 |
2. Proposed Device
| Trade or (Proprietary) Name | : | HySil Super Fast Impression Materials |
|---|---|---|
| Classification Name | : | Impression Material |
| Regulation Number | : | 21CFR872.3660 |
| Devce Classification | : | Class II |
| Classification Product Code | : | ELW |
3. Predicated Device
- -Primary Predicate HySil Impression Materials, Osstem Implant Co., Ltd. (K170736)
4. Description
HySil Super Fast Impression Materials are addition-curing, elastomeric materials with hydrophilic property. They 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 Super Fast Impression Materials meet ISO 4823 standard and consist of three different viscosities (heavy-bodied, medium-bodied, and light-bodied) in delivery system as standard 1:1 50 ml cartridges.
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Image /page/4/Picture/2 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. There is a small superscript "6" next to the word "OSSTEM".
osstem® Osstem Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
5. Substantial Equivalence Matrix
| Proposed Devices | Predicated Devices | Remark | |
|---|---|---|---|
| Device Name | HySil Super FastImpression MaterialsHeavy, Mono, Light | HySil Impression MaterialsPutty, Heavy, Mono, Light,Extra Light, Bite | Different |
| 510(k) No. | K192941 | K170736 | Different |
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Same |
| Indications forUse | HySil Heavy Super Fast isto be used as heavy-bodiedmaterials for:- One-step impressiontechnique (simultaneoustechnique) using single ordual viscosities- Two-step impressiontechnique using dualviscosities- Functional impressionsHySil Mono Super Fast isto be used as a medium-bodied tray or syringeableimpression material 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 andcores indirectlyHySil Light Super Fast is tobe used as syringeableimpression materials for:- Two-step putty-washimpression technique | HySil Putty is to be used aspreliminary materials for:- Two-step Putty-washimpression technique- One-step Putty-washimpression techniqueHySil 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 asa medium-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 and tripletray techniques- Transferring root postswhen fabricating posts andcores indirectly | Different sincethe predicateddevices have 6types of devices,Putty, Heavy,Mono, Light,Extra Light, andBite while theproposed deviceshave 3 types ofdevices includingHeavy, Mono,and Light.Although thereare differences innumber of types,the Indicationsfor UseStatements ofHeavy, Mono andLight type forboth proposedand predicateddevices are same. |
| - One-step putty-washimpression technique- Two-step impressiontechnique using dualviscosities- Reline impressions- Fabricating full or partialdentures | HySil Light is to be used assyringeable impressionmaterials for:- Two-step putty-washimpression technique- One-step putty-washimpression technique- Two-step impressiontechnique using dualviscosities- Reline impressions- Fabricating full or partialdenturesHySil Extra Light is to beused as syringeableimpression materials for:- Two-step putty-washimpression technique- One-step putty-washimpression technique- Two-step impressiontechnique using dualviscosities- Reline impressions- Fabricating full or partialdenturesHySil Bite is used forimpression as below.- Taking occlusal surfaces- Confirming occlusalsurfaces- Recording after putting thearticulator | ||
| Principle ofOperation | - Be placed on animpression tray (orinjected directly into themouth, depending on thetechnique and device) andused to reproduce thestructure of a patient'steeth and gums- Provide models for studyand for production ofrestorative prostheticdevices | - Be placed on animpression tray (orinjected directly into themouth, depending on thetechnique and device) andused to reproduce thestructure of a patient'steeth and gums- Provide models for studyand for production ofrestorative prostheticdevices | Same |
| Description ofMaterial | Vinylpolysiloxane | Vinylpolysiloxane | Compose withsame affiliatedmaterial, butratios of each |
| component in useare different | |||
| StandardConformed | ISO 4823 | ISO 4823 | Same |
| Working Time | Over 1 min. 15 sec. | Over 2 ~ 2 min. 30 sec. | Proposed deviceshave shorterworking time |
| Shelf-life | 2 years | 2 years | Same |
| S.E. | SimilaritiesThe proposed devices and the predicated devices are made with same affiliatedmaterial called Vinylpolysiloxane conformed to ISO 4823 standard. Both aredelivered in 50 ml catridge with base and catalyst ratio of 1 to 1; have sameindications for use; have same principle of operation; and have same shelf-life.DifferencesCompared to the predicated devices, the proposed devices have differentcomposition ratios which results in shorter working time. However, based on theresults of the performance and the biocompatibility testing, the proposed and thepredicated devices both passed the requirements. Also, there are differences inIndications for Use Statement since the predicated devices have 6 types ofdevices, Putty, Heavy, Mono, Light, Extra Light, and Bite while the proposeddevices have 3 types of devices including Heavy, Mono, and Light. Althoughthere are differences in number of types, the Indications for Use Statements ofHeavy, Mono and Light type for both proposed and predicated devices are same.Thus, the differences in Indications for Use Statement do not affect the substantialequivalence of proposed devices.Therefore, we stated that proposed devices (HySil Heavy, Mono, Light SuperFast Impression Materials) are substantially equivalent to the predicated devices(HySil Heavy, Mono, Light Impression Materials) cleared in K170736. |
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IMPLANT
osstem® Osstem Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
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Osstem Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
6. Indications for Use
HySil Heavy Super Fast 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 Super Fast 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
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Image /page/7/Figure/2 description: This image shows the logo and contact information for Osstem Implant Co., Ltd. The logo includes the company name in bold, black font, with the word "OSSTEM" in orange font on the left side. The address is listed as 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 51 861 4693, and the website is www.osstem.com.
- 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 Light Super Fast is to be used as syringeable impression materials for:
- Two-step putty-wash impression technique
- One-step putty-wash impression technique
- Two-step impression technique using dual viscosities
- Reline impressions
- Fabricating full or partial dentures
7. Summary of Non-clinical Performance Testing
Non-clinical testing data are submitted to demonstrate substantial equivalence.
Biocompatibility Evaluation
Biocompatibility testing was considered followed the FDA Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, " and the ISO 10993 suite of standards.
Sterilization Validation and Shelf-life
Proposed devices are delivered in non-sterile. Therefore, sterilization vas not considered. The Shelf-life testing was considered followed the FDA Guidance Document Shelf Life of Medical Device, ISO 4823 and ISO 3417; and determined shelf-life of proposed devices are 2 years.
Mechanical Properties
Mechanical testing was evaluated following ISO 4823, and it was found that the proposed devices are substantially equivalent to the predicate devices from the result of bench test.
8. Summary of Clnical Testing
No clinical studies are submitted.
9. 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 Super Fast Impression Materials are substantially equivalent to the predicated devices as herein.
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Image /page/8/Picture/2 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".
osstem® Osstem Implant Co., Ltd.
Complant 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
§ 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).