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
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: K102836
• Predicate For: N/A

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.

AI/ML Overview

The DentiAnn Smart Sil is a dental impression material. The acceptance criteria for the device are based on the ISO 4823 standard for dental elastomeric impression materials. The study used to prove the device meets these criteria involved non-clinical performance testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (ISO 4823 Standard)	DentiAnn Smart Sil Reported Performance
DentiAnn Light-body
Working time	~180 sec
Elastic recovery rate	> 96.5%
Linear Dimensional change	< 1.5%
Classification (ISO 4823)	Type 3
DentiAnn Heavy-body
Working time	~147 sec
Elastic recovery rate	> 96.5%
Linear Dimensional change	< 1.5%
Classification (ISO 4823)	Type 1
SmartSil-Putty
Elastic recovery rate	> 96.5%
Linear Dimensional change	< 1.5%
Classification (ISO 4823)	Type 0
SmartSil-Bite
Working time	~15 sec
Linear Dimensional change	< 1.5%
Classification (ISO 4823)	Type 1
Hardness	> 20HD
General Criteria
Component Color Test	Met (implied by overall compliance)
Consistency Test	Met (implied by overall compliance)
Mixing Time Test	Met (implied by overall compliance)
Detail Reproduction Test	Met (implied by overall compliance)
Test for Compatibility with Gypsum	Met (implied by overall compliance)

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for each specific test within ISO 4823. It refers to "the test results" generally. The data provenance is non-clinical, meaning it's from laboratory testing rather than human subjects. The origin of the data is from the manufacturer, SeilGlobal Co., Ltd., which is based in the Republic of Korea. The data is prospective as it was generated to support the 510(k) submission for this specific device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. This is a non-clinical study pertaining to the physical and mechanical properties of a material. Ground truth in this context refers to the defined parameters and methods within the ISO 4823 standard, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set:

Not applicable. Performance was measured against objective standards of ISO 4823 using laboratory equipment, not through expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance:

Not applicable. This device is a dental impression material, not an AI-powered diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a material, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth for the performance testing was based on:

• International Standard ISO 4823: This standard specifies the requirements and test methods for dental elastomeric impression materials.
• International Standard ISO 10993 (Biocompatibility): This set of standards concerns the biological evaluation of medical devices.

8. The Sample Size for the Training Set:

Not applicable. This is a material, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. This device does not use a training set.

Summary

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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.

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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

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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)

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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)

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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

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• 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 bodymaterial for:- Making accurate occlusal registrations- Standards bite registrations in the end biteposition.- Key material for needle point registration.- Production of small model segments	Inlays, OnlaysBonasil A+ Bonabite (bonabite fast set) is to be usedas a light body material for:- Making accurate occlusal registrations- Standards bite registrations in the end biteposition.- 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 specifications1) 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 (ISO4823) : Type 32) 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 (ISO4823) : Type 13) SmartSil-Putty- Elastic recovery rate : more than 96.5%- Linear Dimensional change : less than 1.5%- Classification according to the standards (ISO4823) : Type 04) SmartSil-Bite- Working time : about 15sec- Linear Dimensional change : less than 1.5%- Classification according to the standards (ISO4823) : Type 1- Hardness : more than 20HD	Meets ISO 4823 specifications1) 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 (ISO4823) : Type 32) 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 (ISO4823) : Type 13) Bonasil A+ Putty- Elastic recovery rate : more than 96.5%- Linear Dimensional change : less than 1.5%- Classification according to the standards (ISO4823) : Type 04) Bonasil A+Bonabite- Working time : about 30sec- Linear Dimensional change : less than 1.5%- Classification according to the standards (ISO4823) : Type 2- Hardness : more than 20HD
Mixing ratio	1:1	1:1
Sterility	Non-sterile	Non-sterile

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Conclusion: 9.

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

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).