ProGlass One: Cementation of all types of metal, porcelain fused to metal, resin crowns, inlays, onlays & bridges; Cementation of orthodontic bands; Cementation of stainless steel crowns or orthodontic appliances retained with stainless steel crowns; Base/liner
ProGlass Two: Class III, V and limited class I cavities; Restoration of primary teeth; Core Build Up
ProGlass Two LC: Class III and V restorations; Restoration of Cervical erosions and root surface caries; Core Build Up; Base/Liner
ProGlass Nine: Class I & II cavities; Decidious teeth: final restorative for Class I, II and V; Long term restorative in non-load bearing areas of Class I, II and V; Intermediate restorative & sandwich material for heavy stress bearing; Core build up material
ProGlass Plus: Metal-based restorations; Ceramic inlays; Reinforced ceramic crowns and bridges; All kinds of acrylic/resin crowns, inlays, onlays and bridges
ProGlass Silver: Class I, limited Class II, temporary fillings; Restoration of primary teeth; Core Build Up; Base/Liner

Device Description

The ProGlass cements are classified as a Dental Cement (21 C.F.R. part 872.3275) because they are devices composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

AI/ML Overview

The provided document is a 510(k) summary for Silmet Ltd.'s ProGlass Cements. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, many of the requested categories cannot be fully addressed as a formal study with a test set, ground truth experts, and statistical comparisons was not conducted. The submission relies on the established safety and effectiveness of the predicate devices and the components used.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided document. The 510(k) submission does not detail specific quantitative acceptance criteria for performance metrics (beyond general physical characteristics) that the device must meet, nor does it present a study explicitly comparing the new device's performance against such criteria.

The document includes a table of "Physical characteristics" (Table 2 on page 1) which lists:

Powder/liquid ratios
Mixing time
Working time
Setting time
Light Cure time (for ProGlass Two LC)

However, these are presented as characteristics of the ProGlass Cements, not as performance targets or acceptance criteria with corresponding results from a study designed to prove them. The stated acceptable ranges are implicitly derived from the properties of the predicate devices.

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

Sample Size: Not applicable. No dedicated "test set" in the context of a clinical performance study is described. The submission primarily relies on the well-established properties of the components and the predicate devices.
Data Provenance: Not applicable.

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

Not applicable. As no clinical performance study with a test set requiring expert ground truth was conducted, this information is not provided.

4. Adjudication Method for the Test Set

Not applicable.

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 is a submission for dental cements, not an AI or imaging device, so an MRMC study is irrelevant.

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

Not applicable.

7. The Type of Ground Truth Used

Not applicable in the context of a clinical performance study. The "ground truth" for this 510(k) is effectively the established safety and effectiveness of the predicate devices and the individual components, supported by their long history of clinical use.

8. The Sample Size for the Training Set

Not applicable. There is no training set in the context of an algorithm or AI development.

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

Not applicable.

Summary of the Study that Proves the Device Meets the Acceptance Criteria (Based on the document):

The "study" described in this 510(k) submission is primarily a comparison to predicate devices and a demonstration of component safety and technological equivalence, rather than an independent clinical performance study with explicit acceptance criteria.

Basis of Proof: Silmet Ltd. asserts that ProGlass Cements are safe and effective because:
- All components used in ProGlass Cements are found in legally marketed predicate devices (Fuji I, Fuji II, Fuji II LC, Fuji IX, Fuji Plus, Miracle Mix – all by GC America).
- The material, design, and use concept of ProGlass Cements are similar to these predicate devices.
- The prior use of these components in legally marketed devices and the performance data of those devices support the safety and effectiveness of ProGlass Cements, making additional testing for cytotoxicity, mutagenicity, or other biocompatibility studies unnecessary.
Conclusion: Based on this comparison and component analysis, Silmet Ltd. concludes that ProGlass Cements are substantially equivalent to the predicate devices, thereby meeting the implicit "acceptance criteria" of being as safe and effective as existing legally marketed devices.

This approach is common for Class II medical devices seeking 510(k) clearance, where substantial equivalence to a predicate device eliminates the need for extensive de novo clinical trials unless significant technological differences or new safety/effectiveness questions arise.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the word "SILMET" in bold, black letters. To the right of the word is a gray rectangle with a white circle in the middle. The letters are large and spaced closely together. The rectangle is smaller than the word and is positioned at the same height.

K101869

SEP 2 9 2010

5. 510(k) Summary

This summary of 510(k) safety and effectiveness is being submitted in accordance with requirements of 21 C.F.R. part 872.3275

Date prepared: June 29, 2010

Company

Name	Silmet Ltd
Address	12 Hassadna St., Industrial ParkOr Yehuda 60200. Israel
Telephone	972 3 5331474
Fax	972 3 5331581
Contact	Moshe Zalsman
e-mail	moshe@silmet.co.il

Devices

Trade Name:

ProGlass Cements (ProGlass One, ProGlass Two, ProGlass Two LC, ProGlass Nine, ProGlass Plus, ProGlass Silver)

Classification Name:	Cement, Dental (872.3275)
Common Name:	Glass lonomer Cements
Regulatory class:	Class II

Predicate Devices

Fuji I	(K980695, GC America)
Fuji II	(K980682, GC America)
Fuji II LC	(K961584, GC America)
Fuji IX	(K961448, GC America)
Fuji Duet (Fuji Plus)	(K946100, GC America)
Miracle Mix	(K984505, GC America)

Description

Device function, scientific concept, physical and performance characteristics

Glass Ionomer Cements are based on the reaction of silicate glass powder and polyalkeonic acid (acid - base reation) and have the following essential components:

· an ionic polymer which is a polycarboxylic acid
· a fluoroaluminosilcate (FAS) glass powder
· water
· tartaric acid.

The above components are formulated to provide a powder and a liquid portion. In use the two are combined and a chemical reaction takes place to provide a set cement.

File No, 62010 PG 510k – FDA

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the word "SILMET" in bold, black letters. The letters are large and blocky, and they are arranged horizontally across the image. To the right of the word is a small, pixelated square that is black and white.

General Applications

. Luting crowns, bridges and orthodontic brackets
Restorative cements .
Lining cements, Base. .

Table 1: Device characteristics

	Function	Components
		Powder	Liquid
ProGlass One	Luting Cement	Alumino-silicate glassPolyacrylic acid	Distilled waterPolyacrylic acid
ProGlass Two	Restorative	Alumino-silicate glassPolyacrylic acid	Distilled waterPolyacrylic acid
ProGlass Two LC	Reinforced RestorativeBase/Liner	Alumino-silicate glass	Distilled waterPolyacrylic acid2-hydroxyethyl methacrylate (HEMA)2,2,4, Trimethyl hexamethylenedicarbonate (TMHMD)
ProGlass Nine	RestorativeBase/Liner	Alumino-silicate glassPolyacrylic acid	Polyacrylic acidTartaric acidDistilled water
ProGlass Plus	Luting Cement	Alumino-silicate glass	Distilled waterPolyacrylic acid2-HydroxyethylmethacrylateUrethanedimethacrylate
ProGlass Silver	Restorative	Alumino-silicate glassSilver	Polyacrylic acid

Table 2: Physical characteristics

	ProGlassOne	ProGlassTwo	ProGlassTwo LC	ProGlassNine	ProGlassPlus	ProGlassSilver
Powder /liquid	2.4 / 1.0	3.5 / 1.0	2.3 /1.0	4.1 / 1.0	1.5 / 1.0	4.0 / 1.0
Mixing time (sec)	30"	30"	30"	30"	30"	20"
Working time	2' 30" - 3'	1' 30" - 2'	3'	2' 30"	3'	1'40"
Setting Time (min.sec)	3'10" -	3' 10" - 3'	3' -	3' 30"	3'	4'
Light Cure (sec)			20"

File No. 62010 PG 510k – FDA

ﻜﺮ

SILMET LTD. 12 Hassalna St. Industrial Park. Or Yebuda 6020 Israel. Tel: +972 3 5331474 Fisc +973 3 53158 | e-mail:nifo@silmedental.com

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the word "SILMET" in bold, black letters. The letters are sans-serif and appear to be slightly slanted. To the right of the word "SILMET" is a gray, textured square. The square is filled with a pattern of small, irregular shapes.

Indications for use

Products	Indications for Use
ProGlass One	Cementation of all types of metal, porcelain fused to metal, resin crowns, inlays,onlays & bridgesCementation of orthodontic bandsCementation of stainless steel crowns or orthodontic appliances retained with stainless steel crownsBase/liner
ProGlass Two	Class III, V and limited class I cavitiesRestoration of primary teethCore Build Up
ProGlass Two LC	Class III and V restorationsRestoration of Cervical erosions and root surface cariesCore Build UpBase/Liner
ProGlass Nine	Class I & II cavitiesDecidious teeth: final restorative for Class I, II and VLong term restorative in non-load bearing areas of Class I, II and VIntermediate restorative & sandwich material for heavy stress bearingCore build up material
ProGlass Plus	Metal-based restorationsCeramic inlaysReinforced ceramic crowns and bridgesAll kinds of acrylic/resin crowns, inlays, onlays and bridges
ProGlass Silver	Class I, limited Class II, temporary fillingsRestoration of primary teethCore Build UpBase/Liner

Contraindications: Pulp capping

Technological characteristics

All of the components of ProGlass Cements are found in the legally marketed devices:

Fuji I (K980695, GC America), Fuji II (K980682, GC America), Fuji II LC (K961584, GC America), Fuji IX (K961448, GC America), Fuji Plus (K946100 , GC Ameriea) , Miracle Mix (K984505, GC America)

The material, design and use concept is similar.

The prior use of all the components in the legally marketed devices supports our decision that additional testing for cytotoxicity and mutagenicity as well as additional bio-compatibility studies with the final formulation are not necessary.

We believe that the prior use of these components in legally marketed devices and the performance data and results support the safety and effectiveness of ProGlass Cements for the intended use.

Conclusion

In accordance with 21 C.F.R. part 872.3275 and FDA's " Guidance for the preparation of Premarket Notifications for Dental Cements" and based on the information provided in this premarket notification, Silmet Ltd. concludes that ProGlass Cements are safe and effective and substantially equivalent to the predicate devices described herein.

29 June 2010 SILMET LTD.

CEO: Moshe Zalsman

Signature:

Image /page/2/Picture/15 description: The image shows a drawing of a cell with a label next to it. The cell appears to be in the process of cell division. The label next to the cell has the number 2 on it.

File No. 62010 PG S10k – FDA

.. ..

STLMET LTD. 12 Hussadia St. Industrial Park. Or Yebula 60200 kssel. Tel: +972 3 533158 | e-mail:nfo@silmedental.com

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

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

Ms. Sharon Chaplik SILMET, Limited 12 Hasadna or Yehuda Israel 60200

SEP 2 9 2010

Re: K101869

Trade/Device Name: ProGlass Cements (ProGlass One, ProGlass Two, ProGlass Two LC, ProGlass Nine, ProGlass Plus, ProGlass Silver Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: June 29, 2010 Received: July 2, 2010

Dear Ms. Chaplik:

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.

{4}------------------------------------------------

Page 2- Ms. Chaplik

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the word "SILMET" in bold, black letters. To the right of the word is a square that is filled with a black and white pattern. The pattern appears to be random and textured. The word "SILMET" is the most prominent feature of the image.

4. Indications for Use Statement

SEP 2 9 2010

2101869 510(k) Number (if known):

Device Name: ProGlass Cements ( ProGlass Two, ProGlass Two LC, ProGlass Nine, ProGlass Plus, ProGlass Silver)

Products	Indications for Use
ProGlass One	Cementation of all types of metal, porcelain fused to metal, resincrowns, inlays, onlays & bridgesCementation of orthodontic bandsCementation of stainless steel crowns or orthodontic appliancesretained with stainless steel crownsBase/liner
ProGlass Two	Class III, V and limited class I cavitiesRestoration of primary teethCore Build Up
ProGlass Two LC	Class III and V restorationsRestoration of Cervical erosions and root surface cariesCore Build UpBase/Liner
ProGlass Nine	Class I & II cavitiesDecidious teeth: final restorative for Class I, II and VLong term restorative in non-load bearing areas of Class I, II and VIntermediate restorative & sandwich material for heavy stress bearingCore build up material
ProGlass Plus	Metal-based restorationsCeramic inlaysReinforced ceramic crowns and bridgesAll kinds of acrylic/resin crowns, inlays, onlays and bridges
ProGlass Silver	Class I, limited Class II, temporary fillingsRestoration of primary teethCore Build UpBase/Liner

Prescription Use __ V (Part 21 CFR 801 Subpart D)

AND/OR

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

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

File No. 62010 PG 510k - FDA
------------------------------	--

Concurrence of CDRH, Office of Device (Division Sign-Off ODE)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices Page ___ of ___

	10
510(k) Number:	K101869

SILMET LTD. 12 Hassadna St. Industrial Park. Or Yehuda 60200 Israel. Tel: +972 3 5331474 Fax: +972 3 5331581 e-mail:info@silmetdental.com www.silmetdental.com

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.