K Number
K210041
Device Name
HySil Plus Impression Materials
Date Cleared
2021-03-18

(70 days)

Product Code
Regulation Number
872.3660
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HySil Heavy Plus 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 Plus 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 impressi on 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 Plus 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 Heavy Plus Auto 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 -
Device Description
HySil Heavy Plus, HySil Mono Plus, HySil Light Plus, HySil Heavy Plus Auto (hereinafter referred to as the"HySil Plus Impression Materials") meet ISO 4823 standard and consist of three different viscosities (heavy-bodied, medium-bodied, and light-bodied) in delivery system as standard 1:1 50ml cartridges automix cartridges, 5:1 380ml cartridges for use in most Auto-mix dispensing and mixing systems.
More Information

Not Found

No
The document describes impression materials and their physical properties and intended uses. There is no mention of any software, algorithms, or data processing that would indicate the use of AI/ML.

No
The device description indicates that the HySil Plus Impression Materials are used for taking impressions of teeth and gums, fabricating dental prosthetics, and transferring root posts, which are diagnostic and restorative functions, not therapeutic.

No
The device is described as an impression material used for taking impressions of teeth and gums, fabricating dental restorations, and reline impressions. These are materials for creating molds, not for diagnosing medical conditions or diseases.

No

The device description clearly states it consists of "three different viscosities (heavy-bodied, medium-bodied, and light-bodied) in delivery system as standard 1:1 50ml cartridges automix cartridges, 5:1 380ml cartridges". These are physical materials and delivery systems, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Intended Use: The intended use of the HySil Plus Impression Materials is to create impressions of a patient's teeth and gums for the fabrication of dental restorations and prosthetics. This is a physical process performed directly on the patient's anatomy, not a test on a biological sample.
  • Device Description: The device description confirms it's an impression material delivered in cartridges, consistent with dental impression materials, not diagnostic reagents or kits.
  • Lack of IVD Characteristics: The document does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes. The performance studies focus on physical and mechanical properties relevant to impression materials (detail reproduction, dimensional change, etc.) and biocompatibility, not diagnostic accuracy metrics like sensitivity or specificity.

Therefore, the HySil Plus Impression Materials are medical devices used for dental procedures, but they do not fit the definition of an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

HySil Heavy Plus 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 Plus 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 impressi on 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 Plus 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 Heavy Plus Auto 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 -

Product codes (comma separated list FDA assigned to the subject device)

ELW

Device Description

HySil Heavy Plus, HySil Mono Plus, HySil Light Plus, HySil Heavy Plus Auto (hereinafter referred to as the"HySil Plus Impression Materials") meet ISO 4823 standard and consist of three different viscosities (heavy-bodied, medium-bodied, and light-bodied) in delivery system as standard 1:1 50ml cartridges automix cartridges, 5:1 380ml cartridges for use in most Auto-mix dispensing and mixing systems.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical testing data are submitted to demonstrate substantial equivalence.
Biocompatibility testing was considered followed the FDA Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process," and the ISO 10993-5, 10 and 11 including cytotoxicity, skin sensitization, oral mucosa irritation, and acute systemic toxicity test.
The Shelf-life testing was considered followed the FDA Guidance Document Shelf Life of Medical Device, ISO 4823; and determined shelf-life of proposed devices are 2 years.
Mechanical testing was evaluated following ISO 4823 including visual, weight, package, component color, consistency, detail reproduction, compatibility with gypsum, linear dimensional change, elastic recovery, strain-in-compression, and working time, and it was found that the proposed devices are substantially equivalent to the predicate devices from the result of bench test.
No clinical studies are submitted.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K192941, K181236

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 872.3660 Impression material.

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

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 18, 2021

Osstem Implant Co., Ltd. % Peter Lee QA/RA Manager Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030

Re: K210041

Trade/Device Name: HySil Plus Impression Materials Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: January 19, 2021 Received: January 21, 2021

Dear Peter Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

1

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

510(k) Number: K210041

Device Name: HySil Plus Impression Materials

Indications for Use:

HySil Heavy Plus 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 Plus 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 impressi on 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 Plus 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 Heavy Plus Auto 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 -

X Prescription Use (21 CFR 801 Subpart D)

Over-The Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

3

Osstem Implant Co., Ltd. 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea

Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com

510(k) Summary

Date: December 30, 2020

1. Company and Correspondent making the submission

-Submitter's Name: Osstem Implant Co., Ltd.
-Address: 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan,
48002, Republic of Korea
-Contact: Mr. Jinwoo Bae
-Phone: +82-51-850-2500
-Correspondent's Name: Hiossen Inc.
-Address: 85 Ben Fairless Dr. Fairless Hills, PA 19030
-Contact: Mr. Peter Lee
-Phone: +1-267-759-7031

2. Proposed Device

- Trade or (Proprietary) Name: HySil Plus Impression Materials
- Classification Name: Impression Material
- Regulation Number: 21CFR872.3660
- Devce Classification: Class II
- Classification Product Code: ELW

3. Predicated Device

  • Primary Predicate -HySil Super Fast Impression Materials, Osstem Implant Co., Ltd. (K192941) HySil Heavy Plus Impression Materials, Osstem Implant Co., Ltd. (K181236)

4. Description

HySil Heavy Plus, HySil Mono Plus, HySil Light Plus, HySil Heavy Plus Auto (hereinafter referred to as the"HySil Plus Impression Materials") meet ISO 4823 standard and consist of three different viscosities (heavy-bodied, medium-bodied, and light-bodied) in delivery system as standard 1:1 50ml cartridges automix cartridges, 5:1 380ml cartridges for use in most Auto-mix dispensing and mixing systems.

4

Image /page/4/Picture/2 description: The image shows the logo and contact information for Osstem Implant Co., Ltd. The address is 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea. The telephone number is +82 51 850 2500, the fax number is +82 51 861 4693, and the website address is www.osstem.com.

Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com

5. Substantial Equivalence Matrix

1) HySil Heavy, Mono, Light Plus

| | Proposed Devices | Predicated Devices | Remark | Description
of
Material | Vinylpolysiloxane | Vinylpolysiloxane | Compose with
same affiliated
material, but
ratios of each
component in
use are
different |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-----------------------------------------|------------------------------------------------------------------------------------------------------------|
| Device Name | HySil Plus
Impression Materials
Heavy, Mono, Light,
Heavy Auto | HySil Super Fast
Impression Materials
Heavy, Mono, Light | Different | Standard
Conformed | ISO 4823 | ISO 4823 | Same |
| 510(k) No. | K210041 | K192941 | Different | Working Time | Over 2 min. | Over 1 min. 15 sec. | Proposed
devices have
longer
working time |
| Manufacturer | Osstem Implant Co.,
Ltd. | Osstem Implant Co.,
Ltd. | Same | Shelf-life | 2 years | 2 years | Same |
| Indications for
Use | HySil Heavy Plus 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 Plus 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 | HySil Heavy Super
    Fast 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 Super
    Fast 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 | Same | Compatible
    Accessories | Mixing Tip
    Oral Tip
    Dispenser Gun | Mixing Tip
    Oral Tip
    Dispenser Gun | Same |
    | | | | S.E. | Similarities
    The proposed devices and the predicated devices are made with
    same affiliated material called Vinylpolysiloxane conformed to ISO
    4823 standard. HySil Heavy Plus/Mono Plus/Light Plus are
    delivered in 50 ml catridge with base and catalyst ratio of 1 to 1;
    have same indications for use; have same principle of operation; and
    have same shelf-life.
    Differences
    Compared to the predicated devices, the proposed devices have
    different composition ratio and working time proposed from
    manufacturer. However, the proposed and the predicated devices
    both meet the requirements in regard with performance and
    biocompatibility test according to the ISO4823.
    Thus, the differences in composition rations and delivered type do
    not affect the substantial equivalence of proposed devices since the
    proposed products meet ISO
    Therefore, we stated that proposed devices (HySil Heavy Plus,
    Mono Plus, Light Plus) are substantially equivalent to the
    predicated devices (HySil Heavy, Mono, Light Super Fast
    Impression Materials) cleared in K192941 | | | |
    | | - 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 Plus 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 | - 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 Super Fast
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 | | | | | |
    | Principle of
    Operation | - 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 | Same | | | | |

5

Image /page/5/Picture/2 description: The image contains the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a stylized font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern.

Osstem Implant Co., , Ltd..
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com

6

Image /page/6/Picture/2 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. There is a small circle above and to the right of the word "OSSTEM".

Osstem Implant Co., , Ltd..
66-16, Bansong-ro 513beon-gil, Haeunda-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com

7

Image /page/7/Picture/2 description: The image contains the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font, with a superscript circle containing the letter "O". Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font.

Osstem Implant Co., , Ltd..
66-16, Bansong-ro 513beon-gil, Haeunda-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com

2) HySil Heavy Plus Auto

| | Proposed
Devices | Predicated Devices | | Remark | |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--|
| Device Name | HySil Plus
Impression
Materials
Heavy Plus Auto | HySil
Fast
Impression
Materials
Heavy | HySil
Impression
Materials
Heavy | Different | |
| 510(k) No. | K210041 | K192941 | K181236 | Different | |
| Manufacture
r | Osstem Implant
Co., Ltd. | Osstem Implant
Co., Ltd. | Osstem Implant
Co., Ltd. | Same | |
| Indications
for Use | HySil Heavy
Plus Auto 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 Heavy
    Super Fast 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 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 | Same | |
    | Principle of
    Operation | 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 | 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 | 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 | Same | |
    | | and gums
  • Provide models
    for study and
    for production
    of restorative
    prosthetic
    devices | and gums
  • Provide models
    for study and
    for production
    of restorative
    prosthetic
    devices | and gums
  • Provide models
    for study and
    for production
    of restorative
    prosthetic
    devices | | |
    | Description of
    Material | Vinylpolysiloxane | Vinylpolysiloxane | Vinylpolysiloxane | Compose
    with same
    affiliated
    material,
    but ratios
    of each
    component
    in use are
    different | |
    | Standard
    Conformed | ISO 4823 | ISO 4823 | ISO 4823 | Same | |
    | Working
    Time | Over 2 min. | Over 1 min.
    15 sec. | Over 2 min. | Same/
    Different | |
    | Shelf-life | 2 years | 2 years | 2 years | Same | |
    | Compatible
    Accessories | Mixing Tip
    Auto Mixer | Mixing Tip
    Oral Tip
    Dispenser Gun | Mixing Tip
    Auto Mixer | Same/
    Different | |
    | S.E. | Similarities
    The proposed devices and the predicated devices are made with same
    affiliated material called Vinylpolysiloxane conformed to ISO 4823
    standard. In addition, the proposed product has same indication for use,
    principle of operation and shelf-life.
    Differences
    Compared to the predicated devices, the proposed devices(HySil Heavy
    Plus auto) have different composition ratios, working time proposed
    from manufacturer and delivered type that is bulk type(automix
    cartridge version). In case of automix cartridge version, it has been
    developed for user's convenience. Although, there are some differences
    such as composition ratios, working time and delivered type, the
    proposed and the predicated devices both meet the requirements in
    regard with performance and biocompatibility test according to the
    ISO4823.
    Thus, the differences in composition rations and delivered type do not | | | | |

8

Image /page/8/Picture/2 description: The image shows the logo for Osstem Implant. The logo is in orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern.

OSStem Implant Co., ILtd.
66-16, Bansong-ro 513beon-gil, Haeunda-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com

9

)sstem Implant Co., Ltd

6, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com

affect the substantial equivalence of proposed device. A Therefore, we stated that proposed device (Heavy Plus Auto) is substantially equivalent to the predicated devices (HySil Heavy Super Fast Impression Materials) cleared in K192941.

6. Indications for Use

HySil Heavy Plus 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 Plus 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 Plus 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

7. Summary of Non-clinical Performance Testing

Non-clinical testing data are submitted to demonstrate substantial equivalence.

Biocompatibility Evaluation

Biocompatibility testing was considered followed the FDA Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process," and the ISO 10993-5, 10 and 11 including cytotoxicity, skin sensitization, oral mucosa irritation, and acute systemic toxicity test.

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Osstem Implant Co., Ltd.

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com

Sterilization Validation and Shelf-life

Proposed devices are delivered in non-sterile. Therefore, sterilization was not considered. The Shelf-life testing was considered followed the FDA Guidance Document Shelf Life of Medical Device, ISO 4823; and determined shelf-life of proposed devices are 2 years.

Mechanical Properties

Mechanical testing was evaluated following ISO 4823 including visual, weight, package, component color, consistency, detail reproduction, compatibility with gypsum, linear dimensional change, elastic recovery, strain-in-compression, and working time, and it was found that the proposed devices are substantially equivalent to the predicate devices from the result of bench test.

8. Summary of Clnical Testing

No clinical studies are submitted.

9. Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, Osstem Implant Co., Ltd. concludes that the HySil Plus Impression Materials are substantially equivalent to the predicated devices as herein.