(89 days)
No
The document describes various dental cements and their intended uses, with no mention of AI or ML technology.
No
The device is a dental cement used for restorations and cementation of dental devices, which are generally considered restorative or supportive, not therapeutic in the sense of treating or curing a disease.
No
The device description clearly states "The ProGlass cements are classified as a Dental Cement... 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." This describes a therapeutic or restorative function, not a diagnostic one.
No
The device description clearly states that the ProGlass cements are "devices composed of various materials," indicating a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses listed are all related to dental procedures performed directly on the patient's teeth (cementation, restoration, core build-up, base/liner). These are not tests performed on samples taken from the body to diagnose a condition.
- Device Description: The device is classified as a Dental Cement, which is used to affix dental devices or protect tooth pulp. This aligns with a device used in a clinical setting on a patient, not a diagnostic test.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), diagnostic purposes, or any of the typical characteristics of an IVD.
Therefore, the ProGlass cements are dental devices used for restorative and prosthetic procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
| Products | Indications for Use |
|---|---|
| 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 |
Product codes
EMA
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth/teeth
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K980695, K980682, K961584, K961448, K946100, K984505
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 Park |
| Or Yehuda 60200. Israel | |
| Telephone | 972 3 5331474 |
| Fax | 972 3 5331581 |
| Contact | Moshe Zalsman |
| 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
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.
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
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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 glass | |
| Polyacrylic acid | Distilled water | ||
| Polyacrylic acid | |||
| ProGlass Two | Restorative | Alumino-silicate glass | |
| Polyacrylic acid | Distilled water | ||
| Polyacrylic acid | |||
| ProGlass Two LC | Reinforced Restorative | ||
| Base/Liner | Alumino-silicate glass | Distilled water | |
| Polyacrylic acid | |||
| 2-hydroxyethyl methacrylate (HEMA) | |||
| 2,2,4, Trimethyl hexamethylene | |||
| dicarbonate (TMHMD) | |||
| ProGlass Nine | Restorative | ||
| Base/Liner | Alumino-silicate glass | ||
| Polyacrylic acid | Polyacrylic acid | ||
| Tartaric acid | |||
| Distilled water | |||
| ProGlass Plus | Luting Cement | Alumino-silicate glass | Distilled water |
| Polyacrylic acid | |||
| 2-Hydroxyethylmethacrylate | |||
| Urethanedimethacrylate | |||
| ProGlass Silver | Restorative | Alumino-silicate glass | |
| Silver | Polyacrylic acid |
Table 2: Physical characteristics
| | ProGlass
One | ProGlass
Two | ProGlass
Two LC | ProGlass
Nine | ProGlass
Plus | ProGlass
Silver |
|------------------------|-----------------|-----------------|--------------------|------------------|------------------|--------------------|
| 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
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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 & 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 |
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
13
Signature:
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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
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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, 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 |
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