Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a traditional impression material and its physical properties, with no mention of AI or ML.

Therapeutic

No
The device is an impression material used for diagnostic or restorative purposes in dentistry, not for treating a disease or condition.

Diagnostic

No
The device is described as "impression material" used for "precise duplication of models" and "capturing multiple unit impressions." Its intended use is to create a physical impression, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly states that i-Sil is an "impression material," which is a physical substance used in dentistry, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is for creating dental impressions and duplicating models. This is a physical process used to create a mold of anatomical structures, not to perform tests on biological samples in vitro (outside the body).
Device Description: The device is an impression material, which is a substance used to capture the shape of teeth and oral tissues.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing biological materials.

IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Impression material in a dual phase impression technique
Precise duplication of models
Capturing multiple unit impressions

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

ELW

Device Description

i-Sil is impression material. It has 5 types: Heavy, Medium, Light, Putty and Bite.

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

Dentist, Dental specialist

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)

Bench test:
Test items included Appearance test, Weight test, Component test, Working time test, Minimum strength test, Hardness test, Linear dimensional change test, Consistency, Working time, Detail reproduction, Compatibility with gypsum, Elastic recovery, Strain-in-compression. All tests were conducted against ISO 4823 Dentistry-Elastomeric impression materials standards.

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.

K152766

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

Regulation Number and Section

§ 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).

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 30, 2016

Spident Co., Ltd. % Mark Choi President Spident Usa Inc. 2115 Linwood Ave, 5f, Fort Lee, New Jersey 07024

Re: K161774

Trade/Device Name: I-Sil Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: June 8, 2016 Received: June 28, 2016

Dear Mark Choi:

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 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

1

the quality systems (OS) 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,

Susan Runno, DDS, MA

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name i-Sil

Indications for Use (Describe)

Impression material in a dual phase impression technique
Precise duplication of models
Capturing multiple unit impressions

Type of Use (Select one or both, as applicable)

الص Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

3

510(k) Summarv

[as required by 807.92(c)]

1. Applicant

1. Company : SPIDENT Co.,Ltd.
1. Address : 203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu, Incheon, Korea
1. Tel : 82-32-819-4570
1. Fax : 82-32-819-4572
1. Prepared date : Jun. 8, 2016
1. Contact person : Mark Choi, Tel 201-944-0511
1. Contact person address : 2115 Linwood Ave, 5F, Fort Lee, NJ 07024, U.S.A
1. Submission date : Jul. 5, 2016

2. Device Information

1. Trade name : i-Sil
1. Common name : Dental Impression Materials
1. Classification name : Material, Impression
1. Product code : ELW
1. Regulation number : 872.3660
1. Class of device : Class II
1. Panel : Dental
1. Model codes : 13 model codes including i-Sil Heavy body fast
- i-Sil Heavy body fast -
- i-Sil Heavy body reqular
- i-Sil Heavy body jumbo -
- i-Sil Heavy body monophase
- i-Sil Medium body fast -
- i-Sil Medium body regular -
- i-Sil Medium body jumbo
- i-Sil Medium body denture -
- i-Sil Light body fast -
- i-Sil Light body regular -
- i-Sil Putty fast -
- i-Sil Putty regular -
- i-Sil Bite -

3. The legally marketed device to which we are claiming equivalence

K152766, Dentkist, Inc

4. Device description

i-Sil is impression material. It has 5 types: Heavy, Medium, Light, Putty and Bite.

5. Intended Use :

Impression material in a dual phase impression technique
Precise duplication of models
Capturing multiple unit impressions

4

6. Performance data:

Bench test

Test items	Standards
Appearance test	ISO 4823 Dentistry-Elastomeric impression
materials
Weight test
Component test
Working time test
Minimum strength test
Hardness test
Linear dimensional change test
Consistency
Working time
Detail reproduction
Compatibility with gypsum
Elastic recovery
Strain-in-compression

7. Predicate device comparison table

Heavy body, Medium body and Light body

	Subject Device	Predicate Device
Company	SPIDENT Co.,Ltd.	Dentkist, Inc.
Device Name	i-Sil Heavy body fast/i-Sil Heavy body
regular/i-Sil Heavy body jumbo/i-Sil
Heavy body monophase/i-Sil Medium
body fast/i-Sil Medium body regular/i-Sil
Medium body jumbo/i-Sil Medium body
denture/i-Sil Light body fast/i-Sil Light
body regular	CharmFlex Heavy / CharmFlex Regular /
CharmFlex Denture / CharmFlex Light LV /
CharmFlex Light XLV / CharmFlex Light Premium
510(k) #	N/A	K152766
Classification	Material, Impression	Material, Impression
Product Code	ELW	ELW
Regulation	21 CER 872.3660	21 CER 872.3660
Intended Use	- Impression material in a dual phase
impression technique

Precise duplication of models
Capturing multiple unit impressions | - Impression material in a dual phase impression
technique
Precise duplication of models
Capturing multiple unit impressions |
| Method of
manipulation | 1. Heavy body
Cartridge type :
1)Apply Heavy-body on the tray.

Inject Light-body on tray and directly onto
the teeth. ( Intra oral tip is used to inject
around the teeth.)
Set the tray in the mouth, keep the
material until it is perfectly set in mouth.
After impression material is perfectly set.
store it in room for 30 minutes.

Medium body, Light body

Apply the materials onto the tray of putty
(2-step) / Heavy Body (1-step)
depending on techniques being used.
Set the tray in the mouth, keep the
material until it is perfectly set in mouth.
After impression material is perfectly set,
store it in room for 30 minutes. | 1. CharmFlex Heavy
Tube type: Squeeze equal volume of Base and
Catalyst (1:1) and mix quickly with a tool for within
1'30" and load Heavy-body on the tray.
Cartridge type : Apply Heavy-body on the tray.
Inject Light-body on tray and directly onto the teeth.
( Intra oral tip is used to inject around the teeth.)
Set the tray in the mouth, keep the material until it is
perfectly set in mouth.
After impression material is perfectly set, store it in
room for 30 minutes.

CharmFlex Regular / CharmFlex Denture / CharmFlex
Light LV / CharmFlex Light XLV / CharmFlex Light
Premium

Apply the materials onto the tray of putty (2-step) /
Heavy Body (1-step) depending on techniques
being used.
Set the tray in the mouth, keep the material until it is
perfectly set in mouth.
After impression material is perfectly set, store it in
room for 30 minutes. |
| Chemical composition | - Siloxane vinyl terminated

Siloxane hydride terminated
Surfactant
Silica
Pigments | - Vinyl Siloxane
Hydrogen Siloxane
Silicon dioxide
Calcium silicate
Mineral Oil
Pigments |
| Flow properties | Low viscosity | Low viscosity, Heavy(high viscosity) |

5

| Working time | 1. i-Sil Heavy body series : 1'36"
2. i-Sil Medium body seris : 1'59"
3. i-Sil Light body series : 1'21" | 1.CharmFlex Heavy cartridge type: 1'30"
2.CharmFlex Heavy tube type: 2'
3.CharmFlex Regular/CharmFlex
Denture/CharmFlex Light LV/CharmFlex Light
XLV/CharmFlex Light Premium: 2'2'30" |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mixing time test | 1. i-Sil Heavy body series : 22.6"
2. i-Sil Medium body series : 38"
3. i-Sil Light body series : 26.8 " | 2'4' |
| Consistency test report | 1. i-Sil Heavy body series : 33.83 mm
2. i-Sil Medium body series : 34.83 mm
3. i-Sil Light body series : 45.33 mm | 34.25mm |
| Detail reproduction | 1. i-Sil Heavy body series : pass
2. i-Sil Medium body series : pass
3. i-Sil Light body series : pass | 20 $ μ $ m |
| Linear dimensional
change | 1. i-Sil Heavy body series : 0.18 %
2. i-Sil Medium body series : 0.20 %
3. i-Sil Light body series : 0.15 % | -0.063 % |
| Compatibility with
gypsum | 1. i-Sil Heavy body series : pass
2. i-Sil Medium body series : pass
3. i-Sil Light body series : pass | 20 $ μ $ m |
| Elastic recovery | 1. i-Sil Heavy body series : 99.64 %
2. i-Sil Medium body series : 99.6 %
3. i-Sil Light body series : 99.58 % | 99.67 % |
| Strain-in-
compression | 1. i-Sil Heavy body series : 2.34 %
2. i-Sil Medium body series : 3.29 %
3. i-Sil Light body series : 4.94 % | 4.12 % |
| Keeping qualities | cool and dry place (1824 $ ° $ C/6475 °F) | cool and dry place (18~~24 ℃/64~~75 °F) |
| Curve of the shrinkage | No data | No data |
| Use | Dentist, Dental specialist | Dentist, Dental specialist |

2) Putty

	Subject Device	Predicate Device
Company	SPIDENT Co.,Ltd.	Dentkist, Inc.
Device Name	i-Sil Putty fast
i-Sil Putty regular	CharmFlex Putty / CharmFlex Putty Green /
CharmFlex Putty Soft
510(k)	N/A	K152766
Classification	Material, Impression	Material, Impression
Product Code	ELW	ELW
Regulation	21 CER 872.3660	21 CER 872.3660
Intended Use	- Impression material in a dual phase
impression technique

Precise duplication of models
Capturing multiple unit impressions | - Impression material in a dual phase impression
technique
Precise duplication of models
Capturing multiple unit impressions |
| Method of
manipulation | 1. Take out the same amount of Base and
Catalyst. (1:1 vol.)

Knead them properly with hands until a
mixed color is attained. Wear disposable vinyl
gloves to prevent your hands from incurring an
allergic reaction.
Apply the mixed material to the tray and set
into the mouth.
After the material is perfectly set, remove
from the mouth.
Set the tray with Light-body on the
completed Putty-body into the mouth.
After the material is perfectly set, store it in
room for 30 minutes. | 1. Take out the same amount of Base and Catalyst. (1:1
vol.)
Knead them properly with hands until a
mixed color is attained. Wear disposable vinyl
gloves to prevent your hands from incurring an
allergic reaction.
Apply the mixed material to the tray and set into the
mouth.
After the material is perfectly set, remove from the
mouth.
Set the tray with Light-body on the completed Putty-
body into the mouth.
After the material is perfectly set, store it in room for
30 minutes. |
| Chemical composition | - Siloxane vinyl terminated

Siloxane hydride terminated
Surfactant
Silica
Pigments | -Polyvinyl siloxane
-Silica |
| Flow properties | High viscosity | High viscosity |
| Mixing time test | i-Sil Putty fast, i-Sil Putty regular: 41" | 30"~40" |
| Consistency test | i-Sil Putty fast, i-Sil Putty regular: 31.75
mm | 25.83 mm |
| report | mm | |

6

Detail reproduction	i-Sil Putty fast, i-Sil Putty regular: pass	pass
Linear dimensional
change	i-Sil Putty fast, i-Sil Putty regular: 0.35 %	-0.213 %
Compatibility with
gypsum	i-Sil Putty fast, i-Sil Putty regular: pass	pass
Elastic recovery	i-Sil Putty fast, i-Sil Putty regular:
99.01 %	99.75 %
Strain-in-compression	i-Sil Putty fast, i-Sil Putty regular: 3.26 %	3.28 %
Keeping qualities	cool and dry place (18~~24 °C/64~~75 °F)	cool and dry place (18~~24 °C/64~~75 °F)
Curve of the
shrinkage	No data	No data
Use	Dentist, Dental specialist	Dentist, Dental specialist

3) Bite

	Subject Device	Predicate Device
Company	SPIDENT Co.,Ltd.	Dentkist, Inc.
Device Name		CharmFlex Bite / CharmFlex Bite Clear /
	I-Sil Bite	CharmFlex Bite Fast
510(k)	N/A	K152766
Classification	Material, Impression	Material, Impression
Product Code	ELW	ELW
Regulation	21 CER 872.3660	21 CER 872.3660
Intended Use	- Impression material in a dual phase
impression technique

Precise duplication of models
Capturing multiple unit impressions | - Impression material in a dual phase impression
technique
Precise duplication of models
Capturing multiple unit impressions |
| Method of
manipulation | 1. Check the expiration date and avoid
package contamination.

Follow the instructions for use before using.
Place a disposable mixing tip on cartridge,
and place the cartridge on exclusive mixing
gun.
Check to be made to mix well during
extrusion through the tips.
Apply bite registration material directly onto
the occlusal surfaces.
Set this material to intraoral until the impression
material completely polymerized.
Remove the set bite registration from
intraoral.
Make a master cast with a instrument such
as a dental knife. | 1. Check the expiration date and avoid package
contamination.
Follow the instructions for use before using.
Place a disposable mixing tip on cartridge, and place
the cartridge on exclusive mixing gun.
Check to be made to mix well during extrusion
through the tips.
Apply bite registration material directly onto the
occlusal surfaces.
Set this material to intraoral until the impression material
completely polymerized.
Remove the set bite registration from intraoral.
Make a master cast with a instrument such as a
dental knife. |
| Chemical composition | - Siloxane vinyl terminated

Siloxane hydride terminated
Surfactant
Silica
Pigments | - Polyvinyl siloxane
Silica |
| Working time | 30" ↑ | 15" ↑ |
| Flexural strength | pass | pass |
| Hardness | 87.4 HD | pass |
| Linear dimensional
change | 0.064 % | pass |
| Safety | safe | safe |
| Keeping qualities | cool and dry place (18~~24 °C/64~~75 °F) | cool and dry place (18~~24 °C/64~~75 °F) |
| Curve of the
shrinkage | brittle feature | brittle feature |
| Use | Dentist, Dental specialist | Dentist, Dental specialist |

9. Conclusion:

The Device is investigated for substantially equivalent in intended use and technological characteristics to predicate device.

Comparison results demonstrate that the specifications and performance of the device are same as functional and effective as the legally marketed predicate device.

Therefore, it is concluded that I-Sil is substantially equivalent to the legally marketed predicate device.

Intended Use / Indications for Use

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

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

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

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

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

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

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

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

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).

§ 872.3660 Impression material.

Indications for Use

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

510(k) Summarv

1. Applicant

2. Device Information

3. The legally marketed device to which we are claiming equivalence

4. Device description

5. Intended Use :

6. Performance data:

7. Predicate device comparison table

2) Putty

3) Bite

9. Conclusion:

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW