HySil Impression Materials

K170736 · Osstem Implant Co., Ltd. · ELW · Jun 7, 2017 · Dental

Device Facts

• Record ID: K170736
• Device Name: HySil Impression Materials
• Applicant: Osstem Implant Co., Ltd.
• Product Code: ELW · Dental
• Decision Date: Jun 7, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

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.

Device Story

HySil Impression Materials are addition-curing, hydrophilic vinylpolysiloxane elastomers. Available in six viscosities (putty, heavy, mono, light, extra-light, bite) and delivery systems (automix cartridges or putty jars). Used by dental professionals to capture dental anatomy for study models and prosthetic fabrication. Materials are placed on trays or injected intraorally; they cure to form accurate, dimensionally stable impressions. Benefits include high tear strength and resistance to deformation, facilitating precise restorative outcomes.

Clinical Evidence

No clinical data. Bench testing only. Performance evaluated per ISO 4823 and DIN 13903, including consistency, detail reproduction, linear dimensional change, elastic recovery, and strain-in-compression. Biocompatibility testing performed per ISO 10993 (cytotoxicity, sensitization, mucosa irritation).

Technological Characteristics

Addition-curing vinylpolysiloxane elastomer. Available in six viscosities (Type 0-3 per ISO 4823). Delivery via 1:1 50ml automix cartridges or putty jars. Non-electronic, mechanical impression material. Biocompatibility per ISO 10993.

Indications for Use

Indicated for dental impression procedures including putty-wash techniques (one-step/two-step), heavy-bodied tray impressions, functional impressions, and syringeable impressions for fixed/removable restorations, implants, crown/bridgework, inlays, full/partial dentures, reline impressions, and root post transfers. HySil Bite is indicated for occlusal surface recording and bite registration.

Regulatory Classification

Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Special Controls

*Classification.* Class II (Special Controls).

Predicate Devices

• Suflex Impression Materials (K133527)
• CharmFlex Bite Fast (K152766)

Reference Devices

• Hyflex Impression Materials (K151262)

Submission Summary (Full Text)

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#### 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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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Section 006

)SSTEM Implant Co., Ltd 16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: [phone] Fax: [phone] 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

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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: [phone] Fax: [phone] 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)

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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 [phone] Fax: [phone] www.osstem.com

## 510(k) Summary

Date: March 27, 2017

1. Company and Correspondent making the submission:

| - Submitter's Name: | Osstem Implant Co., Ltd. |
|-------------------------|--------------------------------------------------------------------------|
| - Address | # 66-16, Bansong-ro 513beon-gil, Haeundae-gu<br>Busan, Republic of Korea |
| - Contact: | Mr. Heekwon Son |
| - Phone: | [phone] |
| - Correspondent's Name: | HIOSSEN Inc. |
| - Address: | 85 Ben Fairless Dr. Fairless Hills, PA 19030 |
| - Contact: | DAVID KIM |
| - Phone: | 267 759 7031 |

- 2. 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 |

- 3. 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.

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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: [phone] Fax: [phone] 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<br>Information | HySil Impression material<br>Putty, Extra-Light | Suflex Impression material<br>Putty, Light | |
| Company | Osstem Implant Co., Ltd. | Osstem Germany GmbH | |
| 510(k) No. | Proposed | K133527 | |
| Indication<br>for Use | HySil Putty is to be used as<br>preliminary materials for:<br>• Two-step Putty-wash<br>impression technique<br>• One-step Putty-wash<br>impression technique<br>HySil Heavy is to be used as<br>heavy-bodied materials for:<br>• One-step impression<br>technique (simultaneous<br>technique)<br>using single or dual viscosities<br>• Two-step impression<br>technique using dual viscosities<br>• Functional impressions<br>HySil Mono is to be used as a<br>medium-bodied tray or<br>syringeable impression material<br>for: | *Suflex Putty is to be used as<br>panasil putty material for;<br>-Two step putty impression<br>technique<br>-One step putty impression<br>technique<br>-Two step putty impression<br>technique using a foil(plastic<br>putty spacer)<br>-One step putty impression<br>technique for forming functional<br>peripheries.<br>*Suflex Heavy is to be used a s<br>panasil tray material for;<br>-One step impression technique<br>using single or dual viscosities.<br>-Two step impression technique<br>using dual viscosities<br>-Functional impressions.<br>*Suflex Mono is to be used as | The subject<br>device and<br>primary<br>predicate have<br>slightly<br>different<br>Indications for<br>Use language.<br>However, the<br>difference in<br>language does<br>not change the<br>intended use<br>or substantial<br>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<br>articulator | | |
| Description<br>of Material | Vinylpolysiloxane | Vinylpolysiloxane | Composed<br>with same<br>affiliated<br>material, but<br>ratios of each<br>component in<br>use are slightly<br>different. |
| Standard<br>Conformed | ISO4823 | ISO4823 | Identical |
| Intended Use | - be placed on an impression<br>tray<br>(or injected directly into the<br>mouth, depending on the<br>technique and device)and used<br>to reproduce the structure of a<br>patient's teeth and gums.<br>- provide models for study and<br>for production of restorative<br>prosthetic devices. | - be placed on an impression<br>tray<br>(or injected directly into the<br>mouth, depending on the<br>technique and device)and used<br>to reproduce the structure of a<br>patient's teeth and gums.<br>- provide models for study and<br>for production of restorative<br>prosthetic devices. | Identical |
| SE | Similarities:<br>The subject devices and the predicate devices have same indications for use and<br>intended use. They are all conformed to the ISO 4823 standard; also, both products are<br>composed with same affiliated material called Vinylpolysiloxane. Therefore, the results<br>of the performance testing and their composition are substantially equivalent.<br><br>Differences: | | |
| | The ratios of each component or kinds of pigments of the materials in use are slightly<br>different. However, based on the results of the performance and the biocompatibility<br>testing, the subject and the predicate devices pass the requirements. | | |
| | .: Therefore, we state that HySil Impression Material is substantially equivalent to the<br>predicate devices, Suflex Impression Material (K133527). | | |
| - Bite | | | |
| | Subject device | Predicate device | |
| Descriptive<br>Information | HySil Impression material<br><i>&lt;Bite&gt;</i> | CharmFlex<br>CharmFlex® Bite Fast | |
| Company | Osstem Implant Co., Ltd. | Dentkist, Inc | |
| 510(k) No. | Proposed | K152766 | |
| Description<br>(Indication<br>for use) | HySil Bite is used for<br>impression as below.<br>- Taking occlusal surfaces<br>- Confirming occlusal surfaces<br>- Recording after putting the<br>articulator | CharmFlex®Bite series are bite<br>registration impression material<br>to measure of the occlusal<br>surface,<br>impression of the teeth for a<br>three-dimension position of the<br>mandible in relation to the<br>maxilla. It has a short<br>polymerization time and a high<br>final hardness. Making it<br>suitable for bite registration. | The subject<br>device and<br>predicate have<br>slightly<br>different<br>Indications for<br>Use<br>description)<br>language.<br>However, the<br>difference in<br>language does<br>not change the<br>intended use<br>or substantial<br>equivalence. |
| Description<br>of Material | Vinylpolysiloxane | Vinylpolysiloxane | Composed<br>with same<br>affiliated<br>material, but<br>ratios of each<br>component in<br>use are slightly<br>different. |
| Standard<br>Conformed | DIN 13903 | CharmFlex® Bite Fast is tested<br>according to DIN 13903 | Identical |
| SE | Similarities:<br>According to comparison test between the subject device and the predicate device,<br>both of them are conformed to DIN 13903 standard; also, both products are composed<br>with same affiliated material called Vinylpolysiloxane. Therefore, the results of the<br>performance testing and their composition are substantially equivalent.<br>Differences:<br>The ratios of each component of the materials in use are slightly different. However,<br>based on the results of the performance and the biocompatibility testing, the subject<br>and the predicate devices pass the requirements. | | |

## - Putty, Extra-Light

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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: [phone] Fax: [phone] www.osstem.com

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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: [phone] Fax: [phone] www.osstem.com

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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: [phone] Fax: [phone] www.osstem.com

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### 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: [phone] Fax: [phone] www.osstem.com

: Therefore, we state that HySil Impression material, Bite is substantially equivalent to the predicate devices, CharmFlex® Bite Fast (K152766).

- 5. 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.

- 6. 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 .

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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: [phone] Fax: [phone] 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

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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: [phone] Fax: [phone] 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<br><K133527> | |
| | Extra Light | Putty | Light | Putty |
| Type | Type 3 | Type 0 | Type 3…