(89 days)
HySil Putty is to be used as preliminary materials for:
- Two-step Putty-wash impression technique .
- · One-step Putty-wash impression technique
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 Light 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 Extra Light 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 Bite is used for impression as below.
- Taking occlusal surfaces
- Confirming occlusal surfaces
- · Recording after putting the articulator
HySil Impression Materials are addition-curing, elastomeric materials with hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation. The HySil impression materials family consists of six different viscosities (putty, heavy, mono, light. Extra-light and Bite) available in an assortment of delivery systems: standard 1:1 50 ml automix cartridges, and traditional 1:1 putty jars.
Putty, Heavy, Mono, Light and Extra-light of this proposed devices are classified into Type 0, Type 1, Type 2, and Type 3 according to ISO 4823, and Bite is classified as Dentistry - Jaw relation recording material according to DIN 13903 HySil Bite is an addition-curing silicone bite registration materials in a 50ml 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.
This is a 510(k) premarket notification for a dental impression material, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (e.g., sample sizes for test/training sets, expert adjudication, MRMC studies, standalone algorithm performance) are not applicable.
The submission focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance testing and biocompatibility.
Here's the information that can be extracted from the provided text, aligning with the categories where applicable for a non-AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance
For HySil Extra Light and HySil Putty (ISO 4823 and ISO 10993 family):
| Performance Characteristic | Acceptance Criterion (Predicate) | Reported Device Performance (HySil Extra Light) | Reported Device Performance (HySil Putty) |
|---|---|---|---|
| Component Colour | Pass | Pass | Pass |
| Weight (Volume) test | Pass | Pass | Pass |
| Package | Pass | Pass | Pass |
| Consistency | 45.03mm (Light), 26.86mm (Putty) | 44.61mm | 31.27mm |
| Working Time | 2.25 min (Light) | 3.6 min | - |
| Mixing Time | 25 sec (Putty) | - | 38 sec |
| Detail Reproduction | Pass | Pass | Pass |
| Compatibility with Gypsum | Pass | Pass | Pass |
| Linear Dimensional change | 0.04% | 0.027% | 0.031% |
| Elastic Recovery | 98.33% (Light), 97.78% (Putty) | 99.5% | 99.8% |
| Strain-in-Compression | 3.87% (Light), 4.70% (Putty) | 2.6% | 1.6% |
| Cytotoxicity | Pass | Pass | Pass |
| Oral Irritation | Pass | Pass | Pass |
| Maximization and Sensitization | Pass | Pass | Pass |
For HySil Bite (DIN 13903 and ISO 10993 family):
| Performance Characteristic | Acceptance Criterion (Predicate) | Reported Device Performance (HySil Bite) |
|---|---|---|
| Colours | Pass | Pass |
| Working Time (Processing Time) | Pass | Pass |
| Minimum Period Spent in the Mouth | 1 min. 30 sec | 1 min. 30 sec |
| Recovery after Deformation | more than 0.1mm | more than 0.1mm |
| Load Endurance during Bending | Pass | Pass |
| Hardness Degree (HD) | More than 20 HD (Predicate values: 74 HD, 72 HD, 70 HD, 64 HD, 70 HD) | 50 HD |
| Linear Dimensional Change | shall be within ± 1.5 % (Predicate values: 0.00%, 0.00%, 0.10%, 0.10%, 0.02%) | - 0.16 % |
| Cytotoxicity | Pass | Pass |
| Oral Irritation | Pass | Pass |
| Maximization and Sensitization | Pass | Pass |
2. Sample size used for the test set and the data provenance:
- The document implies that testing was performed on the HySil Impression Materials as the "subject device" against predicate devices.
- The exact sample sizes for each specific test (e.g., how many specimens were tested for linear dimensional change) are not explicitly stated in the provided text.
- Data Provenance: The manufacturer is Osstem Implant Co., Ltd., located in Busan, Republic of Korea. The testing was conducted as part of their 510(k) submission, suggesting it was internal testing by the manufacturer or a contracted lab. The data would be considered prospective as it was generated to support this specific regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This question is not applicable as the submission is for a material, not an AI/ML device that generates diagnoses or interpretations requiring expert ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable as this is not an AI/ML device involving human interpretation requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This question is not applicable as this is not an AI/ML device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- This question is not applicable as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the physical and mechanical properties, the "ground truth" or acceptance criteria are based on recognized international standards:
- ISO 4823 for general impression materials.
- DIN 13903 for jaw relation recording materials (HySil Bite).
- For biocompatibility, the "ground truth" is based on ISO 10993 family standards (e.g., ISO 10993-5 for cytotoxicity, ISO 10993-10 for sensitization and irritation).
- The device performance is compared directly to the specified requirements within these standards and the reported performance of legally marketed predicate devices.
8. The sample size for the training set:
- This question is not applicable as this is not an AI/ML device. No training set was used.
9. How the ground truth for the training set was established:
- This question is not applicable as this is not an AI/ML device. No training set was used.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Osstem Implant Co., Ltd.. % David Kim Manager HiOSSEN Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030
Re: K170736
Trade/Device Name: HySil Impression Materials Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: March 1, 2016 Received: March 28, 2017
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. 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
Image /page/0/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other, with a curved element below them.
June 7, 2017
{1}------------------------------------------------
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 the quality systems (QS) 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,
Mary S. Runner -A
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}------------------------------------------------
Section 006
)SSTEM Implant Co., Ltd 16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
510(k) Number K _ K170736
Device Name : HySil Impression Materials
Indication for use :
HySil Putty is to be used as preliminary materials for:
- Two-step Putty-wash impression technique .
- · One-step Putty-wash impression technique
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 Light 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 Extra Light 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
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for OSSTEM Implant. The logo features the word "OSSTEM" in a bold, sans-serif font, with the word "IMPLANT" in a smaller font below it. To the left of the text is a stylized graphic. The image also includes the address "66-16, Bansong-ro 513beon-gil" and the telephone number "02-51-050-2500".
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
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)
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with the word "IMPLANT" written in gray below it. The logo is simple and modern, and it is likely used to promote the company's dental implant products.
6, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
510(k) Summary
Date: March 27, 2017
- Company and Correspondent making the submission:
| - Submitter's Name: | Osstem Implant Co., Ltd. |
|---|---|
| - Address | # 66-16, Bansong-ro 513beon-gil, Haeundae-guBusan, Republic of Korea |
| - Contact: | Mr. Heekwon Son |
| - Phone: | +82 51 850-2575 |
| - Correspondent's Name: | HIOSSEN Inc. |
| - Address: | 85 Ben Fairless Dr. Fairless Hills, PA 19030 |
| - Contact: | DAVID KIM |
| - Phone: | 267 759 7031 |
-
- Device:
| Trade or (Proprietary) Name : | HySil Impression Materials |
|---|---|
| Common or usual name : | Impression material |
| Classification Name : | Material, Impression(21 CFR 872.3660) |
| Regulation Number : | 21CFR872.3660 |
| Device Classification: | Class II |
| Subsequent Product Code: | ELW |
-
- Predicate Device:
Primary Predicate
K133527, Suflex Impression Meterials to include: (Suflex putty, Suflex Heavy, Suflex Mono, Suflex Light), Osstem Germany GmbH.
Reference predicate
K151262, Hyflex Impression Materials including to include: (Hyflex Heavy, Hyflex Mono, Hyflex Light), Osstem Implant Co., Ltd. K152766, CharmFlex®, Dentkist, Inc
4. Description
HySil Impression Materials are addition-curing, elastomeric materials with hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation. The HySil impression materials family consists of six different viscosities (putty, heavy, mono, light. Extra-light and Bite) available in an assortment of delivery systems: standard 1:1 50 ml automix cartridges, and traditional 1:1 putty jars.
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a small circle above the "M". Below the word "OSSTEM", the word "IMPLANT" is written in gray. The logo is simple and modern, and it is likely used to represent a company that specializes in dental implants.
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
Putty, Heavy, Mono, Light and Extra-light of this proposed devices are classified into Type 0, Type 1, Type 2, and Type 3 according to ISO 4823, and Bite is classified as Dentistry - Jaw relation recording material according to DIN 13903 HySil Bite is an addition-curing silicone bite registration materials in a 50ml 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.
Substantial Equivalence Chart
- Heavy, Mono, and Light
The predicate devices, Hyflex Heavy, Mono, and Light (K151262) are re-submitted to change their name as Hysil Heavy, Mono, and Light. There are no changes in composition, indications for use, technological characteristics, biocompatibilities, etc. They have difference in name only.
| Subject device | Predicate device | Remark | |
|---|---|---|---|
| DescriptiveInformation | HySil Impression materialPutty, Extra-Light | Suflex Impression materialPutty, Light | |
| Company | Osstem Implant Co., Ltd. | Osstem Germany GmbH | |
| 510(k) No. | Proposed | K133527 | |
| Indicationfor Use | 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 or dual viscosities• Two-step impressiontechnique using dual viscosities• Functional impressionsHySil Mono is to be used as amedium-bodied tray orsyringeable impression materialfor: | *Suflex Putty is to be used aspanasil putty material for;-Two step putty impressiontechnique-One step putty impressiontechnique-Two step putty impressiontechnique using a foil(plasticputty spacer)-One step putty impressiontechnique for forming functionalperipheries.*Suflex Heavy is to be used a spanasil tray material for;-One step impression techniqueusing single or dual viscosities.-Two step impression techniqueusing dual viscosities-Functional impressions.*Suflex Mono is to be used as | The subjectdevice andprimarypredicate haveslightlydifferentIndications forUse language.However, thedifference inlanguage doesnot change theintended useor substantialequivalence. |
| 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 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 Extra Light 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 Bite is used for impression as below. Taking occlusal surfaces | panasil monophase material for; Taking impression over fixed/removable restorations and implants(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 Transferring root posts when fabricating posts and cores indirectly. *Suflex Light is to be used as panasil contact material for; Two step putty impression technique. One step putty impression technique. One step impression technique using a foil(plastic putty spacer) One step impression technique (simultaneous technique) using dual viscosities. Reline impressions. Fabricating full or partial dentures. | ||
| Confirming occlusal surfaces Recording after putting thearticulator | |||
| Descriptionof Material | Vinylpolysiloxane | Vinylpolysiloxane | Composedwith sameaffiliatedmaterial, butratios of eachcomponent inuse are slightlydifferent. |
| StandardConformed | ISO4823 | ISO4823 | Identical |
| Intended Use | - be placed on an impressiontray(or injected directly into themouth, depending on thetechnique and device)and usedto reproduce the structure of apatient's teeth and gums.- provide models for study andfor production of restorativeprosthetic devices. | - be placed on an impressiontray(or injected directly into themouth, depending on thetechnique and device)and usedto reproduce the structure of apatient's teeth and gums.- provide models for study andfor production of restorativeprosthetic devices. | Identical |
| SE | Similarities:The subject devices and the predicate devices have same indications for use andintended use. They are all conformed to the ISO 4823 standard; also, both products arecomposed with same affiliated material called Vinylpolysiloxane. Therefore, the resultsof the performance testing and their composition are substantially equivalent.Differences: | ||
| The ratios of each component or kinds of pigments of the materials in use are slightlydifferent. However, based on the results of the performance and the biocompatibilitytesting, the subject and the predicate devices pass the requirements. | |||
| .: Therefore, we state that HySil Impression Material is substantially equivalent to thepredicate devices, Suflex Impression Material (K133527). | |||
| - Bite | |||
| Subject device | Predicate device | ||
| DescriptiveInformation | HySil Impression material<Bite> | CharmFlexCharmFlex® Bite Fast | |
| Company | Osstem Implant Co., Ltd. | Dentkist, Inc | |
| 510(k) No. | Proposed | K152766 | |
| Description(Indicationfor use) | HySil Bite is used forimpression as below.- Taking occlusal surfaces- Confirming occlusal surfaces- Recording after putting thearticulator | CharmFlex®Bite series are biteregistration impression materialto measure of the occlusalsurface,impression of the teeth for athree-dimension position of themandible in relation to themaxilla. It has a shortpolymerization time and a highfinal hardness. Making itsuitable for bite registration. | The subjectdevice andpredicate haveslightlydifferentIndications forUsedescription)language.However, thedifference inlanguage doesnot change theintended useor substantialequivalence. |
| Descriptionof Material | Vinylpolysiloxane | Vinylpolysiloxane | Composedwith sameaffiliatedmaterial, butratios of eachcomponent inuse are slightlydifferent. |
| StandardConformed | DIN 13903 | CharmFlex® Bite Fast is testedaccording to DIN 13903 | Identical |
| SE | Similarities:According to comparison test between the subject device and the predicate device,both of them are conformed to DIN 13903 standard; also, both products are composedwith same affiliated material called Vinylpolysiloxane. Therefore, the results of theperformance testing and their composition are substantially equivalent.Differences:The ratios of each component of the materials in use are slightly different. However,based on the results of the performance and the biocompatibility testing, the subjectand the predicate devices pass the requirements. |
- Putty, Extra-Light
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for OSSTEM IMPLANT. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. The logo is simple and modern.
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
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image contains the logo for "OSSTEM IMPLANT". The word "OSSTEM" is in a bold, orange font. Below it, the word "IMPLANT" is in a smaller, gray font.
Section 007
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}------------------------------------------------
Image /page/8/Picture/1 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a small degree symbol next to the "M". Below the word "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and modern.
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
{9}------------------------------------------------
Section 007
Image /page/9/Picture/1 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is in large, bold, orange letters. Below that, the word "IMPLANT" is in smaller, gray letters.
SSTEM Implant Co., Ltd
16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea 'el: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
: Therefore, we state that HySil Impression material, Bite is substantially equivalent to the predicate devices, CharmFlex® Bite Fast (K152766).
-
- Intended use
-
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.
-
- Indication for use
HySil Putty is to be used as preliminary materials for:
- Indication for use
-
. Two-step Putty-wash impression technique
-
. One-step Putty-wash impression technique
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 Light 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 .
{10}------------------------------------------------
Image /page/10/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. The logo is simple and modern.
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
HySil Extra Light 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 Bite is used for impression as below.
- . Taking occlusal surfaces
- Confirming occlusal surfaces
- · Recording after putting the articulator
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)
Additionally bench testing was performed to allow an evaluation of the mechanical properties of HySil in comparison to already marketed products according to ISO 4823.
- Visual. Weight(Volume) test. Package. Component Colour. Consistency. Detail Reproduction, Compatibility with Gypsum, Linear Dimensional change, Elastic Recovery, Strain-in-Compression
HySil Bite is classified as Dentistry - Jaw relation recording material according to DIN 13903
Therefore bench testing (mechanical properties) of HySil Bite was performed according to DIN 13903
- Visual(Colours), Working Time, Minimum Period Spent in the Mouth, Recovery after -Deformation, Load Endurance during Bending, Hardness Degree(HD) and Linear Dimensional Change
{11}------------------------------------------------
Image /page/11/Picture/1 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is in orange, with a small degree symbol next to it. Below that, the word "IMPLANT" is in a smaller, gray font. 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
< Comparison of physical properties and biological result >
HySil Extra Light and HySil Putty <according to ISO 4823 and ISO 10993 family>
| Subject device | Predicate device | |||
|---|---|---|---|---|
| Hysil Impression Meterials | Suflex Impression Meterials<K133527> | |||
| Extra Light | Putty | Light | Putty | |
| Type | Type 3 | Type 0 | Type 3 | Type 0 |
| Component Colour | Pass | Pass | Pass | Pass |
| Weight(Volume) test | Pass | Pass | Pass | Pass |
| Package | Pass | Pass | Pass | Pass |
| Consistency | 44.61mm | 31.27mm | 45.03mm | 26.86 mm |
| Working Time | 3.6min | - | 2.25min | - |
| Mixing Time | - | 38 sec | - | 25 sec. |
| Detail Reproduction | Pass | Pass | Pass | Pass |
| Compatibility withGypsum | Pass | Pass | Pass | Pass |
| Linear Dimensionalchange | 0.027% | 0.031% | 0.04% | 0.04% |
| Elastic Recovery | 99.5% | 99.8% | 98.33% | 97.78% |
| Strain-in-Compression | 2.6% | 1.6% | 3.87% | 4.70% |
| Report of test forcytotoxicity | Pass | Pass | Pass | Pass |
| Report of test for oralirritation | Pass | Pass | Pass | Pass |
| Report of test formaximization andsensitization | Pass | Pass | Pass | Pass |
HySil Bite <according to DIN 13903 and ISO 10993 family>
| Subject device | Predicate device | |
|---|---|---|
| Hysil Impression MeterialsHySil Bite | CharmFlex® Bite< K152766> | |
| Colours | Pass | Pass |
| Working Time | Pass | Pass |
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Image /page/12/Picture/0 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is written in large, bold, orange letters. Below it, the word "IMPLANT" is written in smaller, gray letters. The logo is simple and modern, and it is likely used to represent a company that specializes in dental implants.
Section 007
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
| (Processing Time) | ||
|---|---|---|
| Minimum Period Spentin the Mouth | 1 min. 30 sec | 1 min. 30 sec |
| Recovery afterDeformation | more than 0.1mm | more than 0.1mm |
| Load Endurance duringBending(Flexural strength) | Pass | Pass |
| Hardness Degree(HD)More than 20 HD | 50 HD | 74 HD, 72 HD, 70 HD, 64HD and 70 HD |
| Linear DimensionalChange<shall be="" within="" ±<br="">1.5 %. | - 0.16 % | 0.00%, 0.00%, 0.10%, 0.10%,0.02% |
| Report of test forcytotoxicity | Pass | Pass |
| Report of test for oralirritation | Pass | Pass |
| Report of test formaximization andsensitization | Pass | Pass |
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- Summary of clinical testing No clinical studies are submitted
9. Conclusions
Comparison results demonstrate that the specifications and performance of the device are same as the legally marketed predicate device.
Therefore, Osstem Implant Co., Ltd. believes that the HySil Impression material is substantially equivalent to the currently legally marketed products.
§ 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).