Who is the manufacturer of HySil Plus Impression Materials?

Osstem Implant Co., Ltd. filed the 510(k) submission for HySil Plus Impression Materials (K210041).

What is the FDA product code for HySil Plus Impression Materials?

ELW. It is classified under 21 CFR 872.3660 as a Class 2 device in the Dental panel.

What is the regulatory pathway for HySil Plus Impression Materials?

510(k) clearance (submission type: Traditional).

What are the predicate devices for HySil Plus Impression Materials?

HySil Super Fast Impression Materials (K192941); HySil Heavy Plus Impression Materials (K181236).

Who can help prepare an FDA 510(k) submission like HySil Plus Impression Materials?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HySil Plus Impression Materials

K210041 · Osstem Implant Co., Ltd. · ELW · Mar 18, 2021 · Dental

Device Facts

Record ID	K210041
Device Name	HySil Plus Impression Materials
Applicant	Osstem Implant Co., Ltd.
Product Code	ELW · Dental
Decision Date	Mar 18, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3660
Device Class	Class 2

Intended Use

HySil Heavy Plus 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 Plus 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 Plus 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 Heavy Plus Auto 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 -

Device Story

HySil Plus Impression Materials are vinylpolysiloxane-based dental impression materials; supplied in 1:1 50ml cartridges or 5:1 380ml automix cartridges. Used by dentists/dental technicians in clinical settings to capture precise anatomical structures of teeth and gums. Material is placed on impression trays or injected directly into the mouth; sets to form a negative replica. Output serves as a physical model for study or fabrication of restorative prosthetics (crowns, bridges, dentures, implants). Benefits include accurate reproduction of dental structures for high-quality prosthetic fit. No electronic or software components involved.

Clinical Evidence

No clinical data submitted. Substantial equivalence established through bench testing, including biocompatibility (ISO 10993-5, 10, 11) and mechanical property testing per ISO 4823 (detail reproduction, linear dimensional change, elastic recovery, strain-in-compression, and working time).

Technological Characteristics

Material: Vinylpolysiloxane. Standards: ISO 4823. Delivery: 1:1 50ml cartridges or 5:1 380ml automix cartridges. Shelf-life: 2 years. Non-sterile. No electronic components or software.

Indications for Use

Indicated for dental patients requiring impressions for fixed/removable restorations, implants, crown/bridgework, inlays, full/partial dentures, relines, and post/core fabrication. Used by dental professionals in one-step, two-step, putty-wash, and triple tray techniques.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (Special Controls).

Predicate Devices

HySil Super Fast Impression Materials (K192941)
HySil Heavy Plus Impression Materials (K181236)

Related Devices

K181236 — HySil Impression Materials · Osstem Implant Co., Ltd. · Sep 13, 2018
K191034 — VPS Impression Material · Hygedent, Inc. · Sep 4, 2019
K021416 — AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL · Dentsply Intl. · May 13, 2002
K963766 — 3M PROPLUS SYSTEM · 3M Company · Oct 31, 1996
K092867 — IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT · Kettenbach GmbH & Co. KG · Oct 1, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 18, 2021 Osstem Implant Co., Ltd. % Peter Lee QA/RA Manager Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030 Re: K210041 Trade/Device Name: HySil Plus Impression Materials Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: January 19, 2021 Received: January 21, 2021 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 {1}------------------------------------------------ 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 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 (QS) 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, Michael E. Adjodha, M.ChE. Assistant 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 {2}------------------------------------------------ ### 510(k) Number: K210041 ### Device Name: HySil Plus Impression Materials ### Indications for Use: HySil Heavy Plus 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 Plus 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 Plus 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 Heavy Plus Auto 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 - 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) {3}------------------------------------------------ # 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: December 30, 2020 # 1. Company and Correspondent making the submission | - | Submitter's Name | : Osstem Implant Co., Ltd. | |---|----------------------|----------------------------------------------------------------------------------| | - | Address | : 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, 48002, Republic of Korea | | - | Contact | : Mr. Jinwoo Bae | | - | 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 Plus Impression Materials | |-------------------------------|-----------------------------------| | - Classification Name | : Impression Material | | - Regulation Number | : 21CFR872.3660 | | - Devce Classification | : Class II | | - Classification Product Code | : ELW | # 3. Predicated Device - Primary Predicate -HySil Super Fast Impression Materials, Osstem Implant Co., Ltd. (K192941) HySil Heavy Plus Impression Materials, Osstem Implant Co., Ltd. (K181236) # 4. Description HySil Heavy Plus, HySil Mono Plus, HySil Light Plus, HySil Heavy Plus Auto (hereinafter referred to as the"HySil Plus 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 50ml cartridges automix cartridges, 5:1 380ml cartridges for use in most Auto-mix dispensing and mixing systems. {4}------------------------------------------------ Image /page/4/Picture/2 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 51 861 4693, and the website address is www.osstem.com. Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com # 5. Substantial Equivalence Matrix # 1) HySil Heavy, Mono, Light Plus | | Proposed Devices | Predicated Devices | Remark | Description of Material | Vinylpolysiloxane | Vinylpolysiloxane | Compose with same affiliated material, but ratios of each component in use are different | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-----------------------------------------|------------------------------------------------------------------------------------------------------------| | Device Name | HySil Plus Impression Materials Heavy, Mono, Light, Heavy Auto | HySil Super Fast Impression Materials Heavy, Mono, Light | Different | Standard Conformed | ISO 4823 | ISO 4823 | Same | | 510(k) No. | K210041 | K192941 | Different | Working Time | Over 2 min. | Over 1 min. 15 sec. | Proposed devices have longer working time | | Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Same | Shelf-life | 2 years | 2 years | Same | | Indications for Use | HySil Heavy Plus 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 Plus 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 | 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 | Same | Compatible Accessories | Mixing Tip Oral Tip Dispenser Gun | Mixing Tip Oral Tip Dispenser Gun | Same | | | | | S.E. | Similarities The proposed devices and the predicated devices are made with same affiliated material called Vinylpolysiloxane conformed to ISO 4823 standard. HySil Heavy Plus/Mono Plus/Light Plus are delivered in 50 ml catridge with base and catalyst ratio of 1 to 1; have same indications for use; have same principle of operation; and have same shelf-life. Differences Compared to the predicated devices, the proposed devices have different composition ratio and working time proposed from manufacturer. However, the proposed and the predicated devices both meet the requirements in regard with performance and biocompatibility test according to the ISO4823. Thus, the differences in composition rations and delivered type do not affect the substantial equivalence of proposed devices since the proposed products meet ISO Therefore, we stated that proposed devices (HySil Heavy Plus, Mono Plus, Light Plus) are substantially equivalent to the predicated devices (HySil Heavy, Mono, Light Super Fast Impression Materials) cleared in K192941 | | | | | | - 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 Plus 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 | - 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 | | | | | | | Principle of Operation | - 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 - Provide models for study and for production of restorative prosthetic devices | - 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 - Provide models for study and for production of restorative prosthetic devices | Same | | | | | {5}------------------------------------------------ Image /page/5/Picture/2 description: The image contains the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a stylized font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern. 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}------------------------------------------------ Image /page/6/Picture/2 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. There is a small circle above and to the right of the word "OSSTEM". Osstem Implant Co., , Ltd.. 66-16, Bansong-ro 513beon-gil, Haeunda-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com {7}------------------------------------------------ Image /page/7/Picture/2 description: The image contains the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font, with a superscript circle containing the letter "O". Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. Osstem Implant Co., , Ltd.. 66-16, Bansong-ro 513beon-gil, Haeunda-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com # 2) HySil Heavy Plus Auto | | Proposed Devices | Predicated Devices | | Remark | | |----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--| | Device Name | HySil Plus Impression Materials Heavy Plus Auto | HySil Fast Impression Materials Heavy | HySil Impression Materials Heavy | Different | | | 510(k) No. | K210041 | K192941 | K181236 | Different | | | Manufacture r | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Same | | | Indications for Use | HySil Heavy Plus Auto 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 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 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 | Same | | | Principle of Operation | 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 | 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 | 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 | Same | | | | and gums - Provide models for study and for production of restorative prosthetic devices | and gums - Provide models for study and for production of restorative prosthetic devices | and gums - Provide models for study and for production of restorative prosthetic devices | | | | Description of Material | Vinylpolysiloxane | Vinylpolysiloxane | Vinylpolysiloxane | Compose with same affiliated material, but ratios of each component in use are different | | | Standard Conformed | ISO 4823 | ISO 4823 | ISO 4823 | Same | | | Working Time | Over 2 min. | Over 1 min. 15 sec. | Over 2 min. | Same/ Different | | | Shelf-life | 2 years | 2 years | 2 years | Same | | | Compatible Accessories | Mixing Tip Auto Mixer | Mixing Tip Oral Tip Dispenser Gun | Mixing Tip Auto Mixer | Same/ Different | | | S.E. | Similarities The proposed devices and the predicated devices are made with same affiliated material called Vinylpolysiloxane conformed to ISO 4823 standard. In addition, the proposed product has same indication for use, principle of operation and shelf-life. Differences Compared to the predicated devices, the proposed devices(HySil Heavy Plus auto) have different composition ratios, working time proposed from manufacturer and delivered type that is bulk type(automix cartridge version). In case of automix cartridge version, it has been developed for user's convenience. Although, there are some differences such as composition ratios, working time and delivered type, the proposed and the predicated devices both meet the requirements in regard with performance and biocompatibility test according to the ISO4823. Thus, the differences in composition rations and delivered type do not | | | | | {8}------------------------------------------------ Image /page/8/Picture/2 description: The image shows the logo for Osstem Implant. The logo is in orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern. OSStem Implant Co., ILtd. 66-16, Bansong-ro 513beon-gil, Haeunda-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com {9}------------------------------------------------ # )sstem Implant Co., Ltd 6, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com affect the substantial equivalence of proposed device. A Therefore, we stated that proposed device (Heavy Plus Auto) is substantially equivalent to the predicated devices (HySil Heavy Super Fast Impression Materials) cleared in K192941. ### 6. Indications for Use HySil Heavy Plus 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 Plus 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 Plus 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 10993-5, 10 and 11 including cytotoxicity, skin sensitization, oral mucosa irritation, and acute systemic toxicity test. {10}------------------------------------------------ # 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 # Sterilization Validation and Shelf-life Proposed devices are delivered in non-sterile. Therefore, sterilization was not considered. The Shelf-life testing was considered followed the FDA Guidance Document Shelf Life of Medical Device, ISO 4823; and determined shelf-life of proposed devices are 2 years. # Mechanical Properties Mechanical testing was evaluated following ISO 4823 including visual, weight, package, component color, consistency, detail reproduction, compatibility with gypsum, linear dimensional change, elastic recovery, strain-in-compression, and working time, 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 Plus Impression Materials are substantially equivalent to the predicated devices as herein.