Hyflex Heavy, Hyflex Mono, Hyflex Light

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design with three human profiles facing right, representing health and human services. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 21,2015 Osstem Implant Co., Ltd % Patrick Lim Manager Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030 Re: K151262 Trade/Device Name: Hyflex Heavy, Hyflex Mono, Hyflex Light Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: May 8, 2015 Received: May 13, 2015 Dear Patrick Lim: 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 yours, Susan Runno DDS, MA Erin Keith Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number K Device Name : Hyflex impression materials Indication for use : Hyflex Heavy and Mono are 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. Hyflex Mono is to be used as a medium-bodied tray or syringeable impression material for; - Taking impression 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. - Hyflex Light is to be used as syringeable impression materials for: - Two step putty-wash impression technique. - - -One step putty-wash impression technique. - -One step impression technique using a foil(plastic putty spacer). - Reline impressions. - - Fabricating full or partial dentures. - 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) {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a small superscript "6" next to the "M". Below "OSSTEM", the word "IMPLANT" is written in gray. The logo is simple and modern, and it is likely used to represent the company's brand. # 510(k) Summary This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date: May 8, 2015 1. Company and Correspondent making the submission: | - Submitter's Name :<br>- Address | Osstem Implant Co., Ltd.<br># 66-16, Bansong-ro 513beon-gil, Haeundae-gu,<br>Busan, Republic of Korea | |-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------| | - Contact :<br>- Phone: | Mr. Heekwon Son<br>+51 850-2575 | | - Correspondent's Name:<br>- Address:<br>- Contact:<br>- Phone: | HIOSSEN Inc.<br>85 Ben Fairless Dr. Fairless Hills, PA 19030<br>Patrick Lim<br>888 678 0001 | | 2. Device : | | | Trade or (Proprietary) Name : | Hyflex Impression Materials including to include<br>Hyflex Heavy<br>Hyflex Mono<br>Hyflex Light | | Common or usual name : | Impression material | | Classification Name : | Material, Impression(21 CFR 872.3660)<br>21CFR872.3660<br>Class II | ## 3. Predicate Device: Trade Name: Suflex Impression Meterials to include:(Suflex putty, Suflex Heavy, Suflex Mono, Suflex Light) K133527 {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. A small superscript circle with a 6 inside is located to the right of the word "OSSTEM". Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com ## 4. Description Hyflex Impression Materials are addition-curing, elastomeric materials with hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation. The Hyflex Impression Material family consists of three different viscosities( heavy, mono, light) ### 5. Intended use - The Hyflex impression materials are intended to be 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. ## 6. Indication for use Hyflex Heavy and Mono are 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. Hyflex Mono is to be used as a medium-bodied tray or syringeable impression material for; - Taking impression 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. - Hyflex Light is to be used as syringeable impression materials for; - Two step putty-wash impression technique. - - One step putty-wash impression technique. - - -One step impression technique using a foil(plastic putty spacer). - -Reline impressions. - -Fabricating full or partial dentures 7. Summary of Non-Clinical Performance Testing Biocompatibility tests have been performed to assure biological safety in accordance with the ISO 10993 family. Tests in respect to cytotoxicity(ISO 10993-5), sensitization and mucosa irritation(ISO 10993-10) and a chemical analysis showed, that Hyflex materials' biocompatibility data is comparable to other materials on the market. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in orange, with a small superscript "6" next to it. Below "OSSTEM", the word "IMPLANT" is written in a smaller, gray font. The logo is simple and clean, with a focus on the company name. Additionally bench testing was performed to allow an evaluation of the mechanical properties of Hyflex in comparison to already marketed products. The evaluation covers - Component colours (ISO 4823, 6.1) - | Working time (ISO 4823, 6.3) - Compatibility with gypsum (ISO 4823, 6.4) - | Consistency(ISO 4823, 6.4) - | Detail reproduction(ISO 4823, 6.4) - | Linear dimensional change(ISO 4823, 6.4) - Elastic recovery(ISO 4823, 6.4) - Strain-in-compression(ISO 4823, 6.4) #### < Comparison of physical properties and biological result > | | Hyflex Impression Meterials | | | Suflex Impression Meterials<br>K133527 | | | |---------------------------------------------------------|-----------------------------|----------|----------|----------------------------------------|---------|---------| | | Heavy | Mono | Light | Heavy | Mono | Light | | Consistency | 28.47mm | 35.65mm | 45.60mm | 32.96mm | 38.89mm | 45.03mm | | Working Time | 2.022min | 2.612min | 2.850min | 2.02min | 1.53min | 2.25min | | Detail Reproduction | Pass | Pass | Pass | Pass | Pass | Pass | | Compatibility with<br>Gypsum | Pass | Pass | Pass | Pass | Pass | Pass | | Linear Dimensional<br>change | 0.02% | 0.02% | 0.03% | 0.04% | 0.04% | 0.04% | | Elastic Recovery | 98.80% | 98.60% | 98.70% | 98.41% | 98.77% | 98.33% | | Strain-in-Compression | 2.30% | 3.00% | 2.30% | 3.53% | 4.35% | 3.87% | | Report of test for<br>cytotoxicity | Pass | Pass | Pass | Pass | Pass | Pass | | Report of test for oral<br>irritation | Pass | Pass | Pass | Pass | Pass | Pass | | Report of test for<br>maximization and<br>sensitization | Pass | Pass | Pass | Pass | Pass | Pass | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in orange, with a small superscript "6" next to it. Below "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and clean, with a focus on the company name. 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 - 8. Summary of clinical testing No clinical studies are submitted - 9. Conclusions Osstem Implant Co., Ltd. believes that the Hyflex Impression material is substantially equivalent to the currently legally marketed products. It does not introduce new indications for use, has similar technological characteristics and does not introduce new potential hazards or safety risks.