DentiAnn Smart Sil

• K Number: K143382
• Device Name: DentiAnn Smart Sil
• Manufacturer: SeilGlobal Co., Ltd.
• Date Cleared: 2015-02-23 ( 90 days)
• Product Code: ELW
• Regulation Number: 872.3660

Intended Use

DentiAnn Light-body is to be used as a light body material for: - Two step putty/wash technique - · Single step putty/wash technique - Functional peripheries - Reline impressions - = Crown/bridge work - Inlays, Onlays DentiAnn Heavy-body is to be used as a heavy body material for: - · Two step putty/wash technique - · Single step putty/wash technique - · Functional peripheries - Crown/bridge work - Inlays, Onlays SmartSil-Putty is to be used as a preliminary material for: - · Two step putty/wash technique - · Single step putty/wash technique - · Functional peripheries - Crown/bridge work - · Inlays, Onlays SmartSil-Bite is to be used as a light body material for: - = Making accurate occlusal registrations - Standards bite registrations in the end bite position. - · Key material for needle point registration. - · Production of small model segments

Device Description

DentiAnn Smart Sil is a two component (base paste and catalyst, mixing ratio 1:1) vinyl polysiloxane impression material to be used for impressions, where typically alginates are used. The DentiAnn Smart Sil offers four different viscosities (light, heavy, putty and bite) in delivery systems of cartridges, tubes and/or jars. The device includes accessories such as a mixing tip and a spoon.

Predicate Devices

K102836

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use are for a dental impression material, which is a physical substance and does not involve software or data processing. There is no mention of AI or ML in the document.

Therapeutic

No
This device is an impression material (vinyl polysiloxane) used for creating dental impressions, not for treating any specific disease or condition. It is a diagnostic aid, not a therapeutic device.

Diagnostic

No.

This device is an impression material used for creating molds of teeth and oral structures, which is a step in the fabrication of dental prosthetics. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a two-component vinyl polysiloxane impression material and includes accessories like mixing tips and spoons, indicating it is a physical material and 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 clearly states that the material is used for making impressions of teeth and oral structures for various dental procedures (crown/bridge work, inlays, onlays, etc.). This is a physical process of capturing the shape of anatomical structures.
• Device Description: The description details a vinyl polysiloxane impression material used for creating physical impressions.
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. The device itself is not performing a diagnostic test on a biological sample.

The device is a dental impression material, which is a medical device used in the process of creating dental prosthetics or restorations, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

DentiAnn Light-body is to be used as a light body material for:

• Two step putty/wash technique
• · Single step putty/wash technique
• Functional peripheries
• Reline impressions
• = Crown/bridge work
• Inlays, Onlays

DentiAnn Heavy-body is to be used as a heavy body material for:

• · Two step putty/wash technique
• · Single step putty/wash technique
• · Functional peripheries
• Crown/bridge work
• Inlays, Onlays

SmartSil-Putty is to be used as a preliminary material for:

• · Two step putty/wash technique
• · Single step putty/wash technique
• · Functional peripheries
• Crown/bridge work
• · Inlays, Onlays

SmartSil-Bite is to be used as a light body material for:

• = Making accurate occlusal registrations
• Standards bite registrations in the end bite position.
• · Key material for needle point registration.
• · Production of small model segments

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

ELW

Device Description

DentiAnn Smart Sil is a two component (base paste and catalyst, mixing ratio 1:1) vinyl polysiloxane impression material to be used for impressions, where typically alginates are used. The DentiAnn Smart Sil offers four different viscosities (light, heavy, putty and bite) in delivery systems of cartridges, tubes and/or jars. The device includes accessories such as a mixing tip and a spoon.

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)

The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.

• ISO 4823 - Component Color Test, Consistency Test, Mixing Time Test, Working Time Test, Detail Reproduction Test, Test for Compatibility with Gypsum, Linear Dimensional Change Test, Elastic Recovery Test, and Strain-in-Compression Test
• ISO 10993-5 - Cytotoxicity Test
• ISO 10993-10 Skin Sensitization Test, Oral Mucous Irritation Test.
• ISO 10993-11 - Acute Systemic Toxicity Test
• Other bench testing Shelf life, Visual, Capacity, and Package test.

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

-1) DentiAnn Light-body

• Working time : about180sec
• Elastic recovery rate : more than 96.5%
• Linear Dimensional change : less than 1.5%
• Classification according to the standards (ISO 4823) : Type 3

-2) DentiAnn Heavy-body

• Working time : about 147sec
• Elastic recovery rate : more than 96.5%
• Linear Dimensional change : less than 1.5%
• Classification according to the standards (ISO 4823) : Type 1

-3) SmartSil-Putty

• Elastic recovery rate : more than 96.5%
• Linear Dimensional change : less than 1.5%
• Classification according to the standards (ISO 4823) : Type 0

-4) SmartSil-Bite

• Working time : about 15sec
• Linear Dimensional change : less than 1.5%
• Classification according to the standards (ISO 4823) : Type 1
• Hardness : more than 20HD

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.

K102836

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

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

February 23, 2015

SeilGlobal Co., Ltd. c/o Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group, USA, Inc. 2651 E Chapman Ave., Suite 110 Fullerton, CA 92831

Re: K143382

Trade/Device Name: DentiAnn Smart Sil Regulation Number: 21 CFR 872.3660 Regulation Name: Dental Impression Material Regulatory Class: II Product Code: ELW Dated: November 17, 2014 Received: November 25, 2014

Dear Ms. Chung:

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.

1

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 device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K143382

Device Name DentiAnn Smart Sil

Indications for Use (Describe)

DentiAnn Light-body is to be used as a light body material for:

• Two step putty/wash technique
• · Single step putty/wash technique
• Functional peripheries
• Reline impressions
• = Crown/bridge work
• Inlays, Onlays

DentiAnn Heavy-body is to be used as a heavy body material for:

• · Two step putty/wash technique
• · Single step putty/wash technique
• · Functional peripheries
• Crown/bridge work
• Inlays, Onlays

SmartSil-Putty is to be used as a preliminary material for:

• · Two step putty/wash technique
• · Single step putty/wash technique
• · Functional peripheries
• Crown/bridge work
• · Inlays, Onlays

SmartSil-Bite is to be used as a light body material for:

• = Making accurate occlusal registrations
• Standards bite registrations in the end bite position.
• · Key material for needle point registration.
• · Production of small model segments

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

X 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)

3

510(k) Summary

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: Nov 17, 2014_

Applicant / Submitter: 1.

SeilGlobal Co., Ltd. 191, Gaejwa-ro, Geumjeong-gu, Busan 609-845, Republic of Korea

Tel: [phone] Fax: [phone]

Submission Correspondent: 2.

Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton, CA 92831 Phone: [phone] Fax: [phone] Email: [e-mail]

3. Device:

Proprietary Name:	DentiAnn Smart Sil
Common Name:	Dental Impression Material
Classification Name:	Material, Impression
Classification:	Class II, 21 CFR 872.3660
Classification Product Code:	ELW

Predicate Device: 4.

BONASIL A+ by DMP, Limited (K102836)

4

5. Device Description:

DentiAnn Smart Sil is a two component (base paste and catalyst, mixing ratio 1:1) vinyl polysiloxane impression material to be used for impressions, where typically alginates are used. The DentiAnn Smart Sil offers four different viscosities (light, heavy, putty and bite) in delivery systems of cartridges, tubes and/or jars. The device includes accessories such as a mixing tip and a spoon.

6. Intended Use:

DentiAnn Light-body is to be used as a light body material for:

• . Two step putty/wash technique
• Single step putty/wash technique "
• . Functional peripheries
• י Reline impressions
• י Crown/bridge work
• . Inlays, Onlays

DentiAnn Heavy-body is to be used as a heavy body material for:

• Two step putty/wash technique "
• Single step putty/wash technique .
• . Functional peripheries
• . Crown/bridge work
• Inlays, Onlays .

SmartSil-Putty is to be used as a preliminary material for:

• Two step putty/wash technique .
• Single step putty/wash technique
• Functional peripheries .
• . Crown/bridge work
• Inlays, Onlays "

SmartSil-Bite is to be used as a light body material for:

• Making accurate occlusal registrations .
• Standards bite registrations in the end bite position. .
• Key material for needle point registration. ■
• . Production of small model segments

7. Performance Data(Non-Clinical):

The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.

• " ISO 4823 - Component Color Test, Consistency Test, Mixing Time Test, Working Time Test, Detail Reproduction Test, Test for Compatibility with Gypsum, Linear Dimensional Change Test, Elastic Recovery Test, and Strain-in-Compression Test
• . ISO 10993-5 - Cytotoxicity Test

5

• ISO 10993-10 Skin Sensitization Test, Oral Mucous Irritation Test .
• . ISO 10993-11 - Acute Systemic Toxicity Test
• Other bench testing Shelf life, Visual, Capacity, and Package test .

8. Substantial Equivalence

The DentiAnn SmartSil is substantially equivalent to the predicate device described herein with respect to intended use, device design, accessory components, and delivery method. Also the curing mechanism of the subject device and the predicate devices is substantially equivalent in principle. Therefore, the subject device and the predicate devices are the same in function, and similar in composition and intended use. This supports that the compatibility and safety of the subject device are substantially equivalent to the predicate devices.

The difference might be the compositions of some materials; however, the biocompatibility and the results of performance testing performed according to ISO 4823 show that this difference does not raise issues in safety and effectiveness.

	Subject Device	Predicate Device
510(K) Number	N / A	K102836
Trade Name	DentiAnn SmartSil	BONASIL A+
Manufacturer	SeilGlobal Co., Ltd	DMP, Limited
Product Code	ELW	ELW
Intended Use	DentiAnn Light-body is to be used as a light body material for:
Two step putty/wash technique Single step putty/wash technique Functional peripheries Reline impressions Crown/bridge work Inlays, Onlays DentiAnn Heavy-body is to be used as a heavy body material for:
Two step putty/wash technique Single step putty/wash technique Functional peripheries Crown/bridge work Inlays, Onlays SmartSil-Putty is to be used as a preliminary material for:
Two step putty/wash technique Single step putty/wash technique Functional peripheries Crown/bridge work	Bonasil A+ Light (light normal set, light fast set) is to be used as a light body material for :
Two step putty/wash technique Single step putty/wash technique Functional peripheries Reline impressions Crown/bridge work Inlays, Onlays Bonasil A+ Heavy (heavy normal set, heavy fast set) is to be used as a heavy body material for :
Two step putty/wash technique Single step putty/wash technique Functional peripheries Crown/bridge work Inlays, Onlays Bonasil A+ Putty (putty normal set, putty fast set, putty soft, putty extra hard, lab putty) is to be used as a preliminary material for :
Two step putty/wash technique Single step putty/wash technique Functional peripheries Crown/bridge work
	SmartSil-Bite is to be used as a light body
material for:

• Making accurate occlusal registrations
• Standards bite registrations in the end bite
  position.
• Key material for needle point registration.
• Production of small model segments | Inlays, Onlays
  Bonasil A+ Bonabite (bonabite fast set) is to be used
  as a light body material for:
• Making accurate occlusal registrations
• Standards bite registrations in the end bite
  position.
• Key material for needle point registration.
• Production of small model segments |
  | Raw Material | Vinyl polysiloxane | Vinyl polysiloxane |
  | Human Factor | Ready to use dispensing system | Ready to use dispensing system |
  | Biocompatibility | Biocompatible conforming to ISO 10993-1 | Biocompatible conforming to ISO 10993-1 |
  | Physical Properties | Meets ISO 4823 specifications

1. DentiAnn Light-body

• Working time : about180sec
• Elastic recovery rate : more than 96.5%
• Linear Dimensional change : less than 1.5%
• Classification according to the standards (ISO

4823. : Type 3

4824. DentiAnn Heavy-body

• Working time : about 147sec
• Elastic recovery rate : more than 96.5%
• Linear Dimensional change : less than 1.5%
• Classification according to the standards (ISO

4823. : Type 1

4824. SmartSil-Putty

• Elastic recovery rate : more than 96.5%
• Linear Dimensional change : less than 1.5%
• Classification according to the standards (ISO

4823. : Type 0

4824. SmartSil-Bite

• Working time : about 15sec
• Linear Dimensional change : less than 1.5%
• Classification according to the standards (ISO

4823. : Type 1

• Hardness : more than 20HD | Meets ISO 4823 specifications

1. Bonasil A+ Light

• Working time : about120sec
• Elastic recovery rate : more than 96.5%
• Linear Dimensional change : less than 1.5%
• Classification according to the standards (ISO

4823. : Type 3

4824. Bonasil A+ Heavy

• Working time : about 120sec
• Elastic recovery rate : more than 96.5%
• Linear Dimensional change : less than 1.5%
• Classification according to the standards (ISO

4823. : Type 1

4824. Bonasil A+ Putty

• Elastic recovery rate : more than 96.5%
• Linear Dimensional change : less than 1.5%
• Classification according to the standards (ISO

4823. : Type 0

4824. Bonasil A+Bonabite

• Working time : about 30sec
• Linear Dimensional change : less than 1.5%
• Classification according to the standards (ISO

4823. : Type 2

• Hardness : more than 20HD |
  | Mixing ratio | 1:1 | 1:1 |
  | Sterility | Non-sterile | Non-sterile |

6

7

Conclusion: 9.

Based on the testing results, SeilGlobal Co., Ltd. concludes that the DentiAnn Smart Sil is substantially equivalent to the predicate devices.