(89 days)
No
The device description and performance studies focus on the physical and mechanical properties of the impression material, with no mention of AI or ML.
No.
The device is an impression material used for taking dental impressions, which is a diagnostic and restorative step, not a therapeutic intervention to treat a disease or condition.
No
Explanation: This device is an impression material used for creating physical models of patient's teeth and gums for dental restorations, not for diagnosing medical conditions.
No
The device description clearly states that the device is an "addition-curing, elastomeric material" and describes its physical properties and delivery systems (cartridges and jars), indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the materials being used to create impressions of teeth and gums for dental procedures (crowns, bridges, dentures, etc.). This is a physical process of capturing anatomical shape, not a diagnostic test performed on a biological sample in vitro (outside the body).
- Device Description: The description details the physical properties and types of impression materials. It mentions classifications based on viscosity and dental standards (ISO 4823, DIN 13903), which are relevant to dental materials, not IVDs.
- No mention of biological samples or diagnostic testing: The entire document focuses on the material's properties for creating impressions and its use in dental procedures. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies described are bench tests evaluating the physical and mechanical properties of the impression material, not clinical studies evaluating diagnostic accuracy.
In summary, the HySil Impression Materials are dental devices used for creating physical impressions, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications 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
HySil Bite is used for impression as below. - Taking occlusal surfaces
- Confirming occlusal surfaces
- · Recording after putting the articulator
Product codes
ELW
Device 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's teeth and gums, occlusal surfaces
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)
Summary of Non-Clinical Performance Testing: Bench testing was performed to evaluate the mechanical properties of HySil in comparison to marketed products.
For HySil Putty, Heavy, Mono, Light, and Extra Light: Biocompatibility tests (cytotoxicity (ISO 10993-5), sensitization, and mucosa irritation (ISO 10993-10)) were performed according to ISO 10993 family. Mechanical property testing was performed according to ISO 4823, evaluating Visual, Weight (Volume), Package, Component Colour, Consistency, Detail Reproduction, Compatibility with Gypsum, Linear Dimensional change, Elastic Recovery, and Strain-in-Compression.
For HySil Bite: Bench testing (mechanical properties) was performed according to DIN 13903, evaluating Visual (Colours), Working Time, Minimum Period Spent in the Mouth, Recovery after Deformation, Load Endurance during Bending, Hardness Degree (HD), and Linear Dimensional Change. Biocompatibility tests were also performed according to ISO 10993 family.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
HySil Extra Light and HySil Putty (according to ISO 4823):
- Component Colour: Pass
- Weight(Volume) test: Pass
- Package: Pass
- Consistency: Extra Light 44.61mm, Putty 31.27mm
- Working Time: Extra Light 3.6min, Putty -
- Mixing Time: Extra Light -, Putty 38 sec
- Detail Reproduction: Pass
- Compatibility with Gypsum: Pass
- Linear Dimensional change: Extra Light 0.027%, Putty 0.031%
- Elastic Recovery: Extra Light 99.5%, Putty 99.8%
- Strain-in-Compression: Extra Light 2.6%, Putty 1.6%
- Report of test for cytotoxicity: Pass
- Report of test for oral irritation: Pass
- Report of test for maximization and sensitization: Pass
HySil Bite (according to DIN 13903):
- Colours: Pass
- Working Time (Processing Time): Pass
- Minimum Period Spent in the Mouth: 1 min. 30 sec
- Recovery after Deformation: more than 0.1mm
- Load Endurance during Bending (Flexural strength): Pass
- Hardness Degree (HD): 50 HD
- Linear Dimensional Change: -0.16 %
- Report of test for cytotoxicity: Pass
- Report of test for oral irritation: Pass
- Report of test for maximization and sensitization: Pass
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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-gu |
| Busan, 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 | |
|---|---|---|---|
| Descriptive | |||
| Information | HySil Impression material | ||
| Putty, Extra-Light | Suflex Impression material | ||
| Putty, Light | |||
| Company | Osstem Implant Co., Ltd. | Osstem Germany GmbH | |
| 510(k) No. | Proposed | K133527 | |
| 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: | *Suflex Putty is to be used as | ||
| panasil putty material for; | |||
| -Two step putty impression | |||
| technique | |||
| -One step putty impression | |||
| technique | |||
| -Two step putty impression | |||
| technique using a foil(plastic | |||
| putty spacer) | |||
| -One step putty impression | |||
| technique for forming functional | |||
| peripheries. | |||
| *Suflex Heavy is to be used a s | |||
| panasil tray material for; | |||
| -One step impression technique | |||
| using single or dual viscosities. | |||
| -Two step impression technique | |||
| using dual viscosities | |||
| -Functional impressions. | |||
| *Suflex Mono is to be used as | The subject | ||
| device and | |||
| primary | |||
| predicate have | |||
| slightly | |||
| different | |||
| Indications for | |||
| Use language. | |||
| However, the | |||
| difference in | |||
| language does | |||
| not change the | |||
| intended use | |||
| or substantial | |||
| equivalence. | |||
| 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 the | |||
| articulator | |||
| Description | |||
| of Material | Vinylpolysiloxane | Vinylpolysiloxane | Composed |
| with same | |||
| affiliated | |||
| material, but | |||
| ratios of each | |||
| component in | |||
| use are slightly | |||
| different. | |||
| Standard | |||
| Conformed | ISO4823 | ISO4823 | Identical |
| 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. | - 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. | Identical |
| SE | Similarities:
The subject devices and the predicate devices have same indications for use and
intended use. 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: | | |
| | 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 devices pass the requirements. | | |
| | .: Therefore, we state that HySil Impression Material is substantially equivalent to the
predicate devices, Suflex Impression Material (K133527). | | |
| - Bite | | | |
| | Subject device | Predicate device | |
| Descriptive
Information | HySil Impression material
<Bite> | CharmFlex
CharmFlex® Bite Fast | |
| Company | Osstem Implant Co., Ltd. | Dentkist, Inc | |
| 510(k) No. | Proposed | K152766 | |
| Description
(Indication
for use) | HySil Bite is used for
impression as below.
- Taking occlusal surfaces
- Confirming occlusal surfaces
- Recording after putting the
articulator | CharmFlex®Bite series are bite
registration impression material
to measure of the occlusal
surface,
impression of the teeth for a
three-dimension position of the
mandible in relation to the
maxilla. It has a short
polymerization time and a high
final hardness. Making it
suitable for bite registration. | The subject
device and
predicate have
slightly
different
Indications for
Use
description)
language.
However, the
difference in
language does
not change the
intended use
or substantial
equivalence. |
| Description
of Material | Vinylpolysiloxane | Vinylpolysiloxane | Composed
with same
affiliated
material, but
ratios of each
component in
use are slightly
different. |
| Standard
Conformed | DIN 13903 | CharmFlex® Bite Fast is tested
according 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 composed
with same affiliated material called Vinylpolysiloxane. Therefore, the results of the
performance 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 subject
and 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
HySil Extra Light and HySil Putty
| Subject device | Predicate device | |||
|---|---|---|---|---|
| Hysil Impression Meterials | Suflex Impression Meterials | |||
| 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 with | ||||
| Gypsum | Pass | Pass | Pass | Pass |
| Linear Dimensional | ||||
| change | 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 for | ||||
| cytotoxicity | Pass | Pass | Pass | Pass |
| Report of test for oral | ||||
| irritation | Pass | Pass | Pass | Pass |
| Report of test for | ||||
| maximization and | ||||
| sensitization | Pass | Pass | Pass | Pass |
HySil Bite
| Subject device | Predicate device | |
|---|---|---|
| Hysil Impression Meterials | ||
| HySil Bite | CharmFlex® Bite | |
| 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 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 | ||
| (Flexural strength) | Pass | Pass |
| Hardness Degree(HD) | ||
| More than 20 HD | 50 HD | 74 HD, 72 HD, 70 HD, 64 |
| HD and 70 HD | ||
| Linear Dimensional | ||
| Change | ||
| 1.5 %. | - 0.16 % | 0.00%, 0.00%, 0.10%, 0.10%, |
| 0.02% | ||
| Report of test for | ||
| cytotoxicity | Pass | Pass |
| Report of test for oral | ||
| irritation | Pass | Pass |
| Report of test for | ||
| maximization and | ||
| sensitization | 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.