(126 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of the impression material, with no mention of AI or ML.
No
The device is an impression material used to reproduce the structure of teeth and gums for diagnostic and restorative purposes, not to treat a disease or condition.
No
This device is an impression material used to reproduce the structure of teeth and gums for various dental procedures (e.g., fabricating restorations, dentures) rather than to diagnose a medical condition.
No
The device is described as impression materials (physical substances) and delivery systems (hardware cartridges), not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The HySil Impression materials are used to create physical impressions of a patient's teeth and gums. This is a mechanical process for reproducing anatomical structures, not a test performed on a biological sample to gain diagnostic information.
- Intended Use: The intended uses listed are all related to creating impressions for dental procedures (fabricating restorations, dentures, bite registration), not for diagnosing or monitoring a medical condition.
- Device Description: The description focuses on the physical properties and delivery systems of the impression materials, not on any analytical or diagnostic capabilities.
- Performance Studies: The performance studies described are bench tests evaluating the physical and mechanical properties of the material (consistency, dimensional change, elastic recovery, etc.) and biocompatibility, not studies evaluating diagnostic accuracy (sensitivity, specificity, etc.).
In summary, the HySil Impression materials are dental impression materials used for creating physical models of oral structures, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications 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
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's teeth and gums
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing data are submitted, referenced, or relied upon to demonstrate substantial equivalence.
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. 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.
No clinical studies are submitted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
2
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)
3
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, Busan |
| 612-070, 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.
4
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 |
| Indications | |||
| 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 | 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 | Same |
5
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
| Description
of Material | Vinylpolysiloxane | Vinylpolysiloxane | Composed
with same
affiliated
materials, but
ratios of each
component in
use are
slightly
different |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Standard
Conformed | 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 and
have same shelf life of 2 years. They are all conformed to the ISO 4823 standard;
also, both products are composed with same affiliated material called
Vinylpolysiloxane. Therefore, the results of the performance testing and their
composition are substantially equivalent.
Differences:
Compared to the predicated devices, the proposed devices don't have L-menthol in
their composition. The ratios of each component or kinds of pigments of the
materials in use are slightly different. However, based on the results of the
performance and the biocompatibility testing, the subject and the predicate device
passed 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 |
| Indications | |||
| for Use | HySil Bite is used for | ||
| impression as below. |
- Taking occlusal surfaces
- Confirming occlusal
surfaces - Recording after putting
the articulator | HySil Bite is used for
impression as below. - Taking occlusal surfaces
- Confirming occlusal
surfaces - Recording after putting
the articulator | Same |
| Working
Time | 30 seconds or more | 15 seconds or more | Different |
| Description
of Material | Vinylpolysiloxane | Vinylpolysiloxane | Same |
| Standard
Conformed | DIN 13903 | DIN 13903 | Same |
| Shelf Life | 3 years | 3 years | Same |
6
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 and
have same shelf life of 3 years. They are all conformed to the DIN 13903 standard;
also, both products are composed with same affiliated material called
Vinylpolysiloxane.
Differences:
The working time (processing time) of device is guided by the manufacturer. The
working time of the proposed device is 30 seconds or more while the predicated
device is 15 seconds or more. Physical test for changing guidance of working time
was conducted and it passed the criteria of DIN 13903 standard.
: . Therefore, we state that propose device is substantially equivalent to the
predicated 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.
7
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