(389 days)
No
The device description and performance studies focus on the material properties and chemical reactions of a traditional glass ionomer cement, with no mention of AI/ML or data-driven performance metrics.
No
Explanation: A therapeutic device is designed to treat or alleviate a medical condition. This device is a dental filling cement used for restoration and base linings, which are considered dental procedures but not typically classified as therapeutic in a medical sense. It is a material used to repair or fill teeth, rather than to treat a disease or condition of the body.
No
The device is a self-curing glass ionomer based radiopaque filling cement used for dental restorations, base linings, and core build-up. Its function is to fill cavities and prepare teeth for further restoration, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly states it is a physical material (powder and liquid) used for dental fillings, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for dental filling and related procedures within the mouth. This is a direct treatment or restoration of a physical structure (teeth).
- Device Description: The description details a material used for filling cavities and building up tooth structure. Its operation principle is a chemical reaction that forms a solid material.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze a sample from the body (like blood, urine, or tissue), or provide information about a patient's health status.
- Anatomical Site: The anatomical site is "Dental," which aligns with a therapeutic or restorative device, not typically a diagnostic one.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (within the body) for restorative purposes.
N/A
Intended Use / Indications for Use
Self-curing glass ionomer based radiopaque filling cement, for dental use only. Recommended Indications:
(1) Restoration of primary teeth.
(2) Restorations of Class III, V and limited Class I cavities.
(3) Base linings under composite and amalgam.
(4) Core build-up.
Product codes
EMA
Device Description
Glass Ionomer Cement (Filling) has two types: Filling II. It is a device composed of various materials including Silica, Alumina, Strontium Fluoride in the powder composition and Poly Carboxylic Acid in the liquid composition which intended to serve as a permanent or temporary tooth filling or as base linings. It's a powder liquid system. The basic operation principle of Glass Ionomer Cement (Filling) is acid-base reaction.
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)
Summary of Physical and Chemical Properties Tests were performed using ISO 9917-1:2007. Items tested include Components (conclusion: Within spec set by standard), Net setting time (conclusion: Within spec set by standard), Compressive strength (conclusion: Within spec set by standard), Acid erosion (conclusion: Within spec set by standard), Acid-soluble Lead content (conclusion: Within spec set by standard), and Radio-opacity (conclusion: Within spec set by standard).
Biocompatibility tests were performed to satisfy the ISO 10993 standards. The test items include Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Subchronic Toxicity and Genotoxicity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing 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
March 3, 2017
Shandong Huge Dental Material Corporation Steven Song General Manager No. 68 Shanhai Road, Donggang District Rizhao City, 276800 CN
Re: K160345
Trade/Device Name: Glass Ionomer Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: February 24, 2017 Received: March 1, 2017
Dear Steven Song:
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 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.
1
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,
For 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
Indications for Use
510(k) Number (if known) K160345
Device Name
Glass Ionomer Cement (Filling)
Indications for Use (Describe)
Self-curing glass ionomer based radiopaque filling cement, for dental use only. Recommended Indications:
(1) Restoration of primary teeth.
(2) Restorations of Class III, V and limited Class I cavities.
- (3) Base linings under composite and amalgam.
(4) Core build-up.
| 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) |
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/3/Picture/0 description: The image is a logo for a company called HUGE. The logo is set on an orange oval background. The word "HUGE" is written in large, white, sans-serif letters. To the right of the word "HUGE" are two Chinese characters.
005_510 (k) Summary
Date Summary Prepared: Feb. 24, 2017
Submitter Information:
| Name | Shandong Huge Dental Material Corporation |
|---|---|
| Address | No. 68 Shanhai Road, Donggang District, Rizhao City, |
| Shandong Province, 276800, P.R. China | |
| Telephone | +86 633 2277285 |
| Fax | +86 633 2277298 |
| Contact | Mr. Steven Song |
| zhangyj@hugedent.com |
Device Name
| Table 1: Device name | |
|---|---|
| Trade name | Glass Ionomer Cement (Filling) |
| Common name | Glass Ionomer Cement |
| Classification name | Dental Cement (21 C.F.R. 872.3275, Product Code: EMA) |
Substantially Equivalent Device
| Table 2: Predicate device information | |||
|---|---|---|---|
| Company Name | Device Name | 510 (k) No. | |
| Primary | |||
| Predicate Device | GC AMERICA, INC. | FUJI II | K980682 |
| Reference | |||
| Predicate Device | SILMET, Limited | ProGlass Cements (ProGlass One, ProGlass | |
| Two, ProGlass Two LC, ProGlass Nine, | |||
| ProGlass Plus, ProGlass Silver) | K101869 | ||
| Shandong Huge Dental | |||
| Material Corporation | Glass Ionomer Cement (Luting) | K161851 |
Description of Device
Glass Ionomer Cement (Filling) has two types: Filling II. It is a device composed of various materials including Silica, Alumina, Strontium Fluoride in the powder composition and Poly Carboxylic Acid in the liquid composition which intended to serve as a permanent or
4
Image /page/4/Picture/0 description: The image is a logo for "HUGE". The word "HUGE" is written in large, white, bold letters on an orange oval background. To the right of the word "HUGE" are two small Chinese characters.
temporary tooth filling or as base linings. It's a powder liquid system. The basic operation principle of Glass Ionomer Cement (Filling) is acid-base reaction. The physical properties of Glass Ionomer Cement (Filling) see page 5-4.
Intended for Use / including the indications for use
Self-curing glass ionomer based radiopaque filling cement, for dental use only.
- (1) Restoration of primary teeth.
- (2) Restorations of Class III, V and limited Class I cavities.
- (3) Base linings under composite and amalgam.
- (4) Core build-up.
Summary of Physical and Chemical Properties Tests
List of standards used:
ISO 9917-1:2007 Dentistry-- Water-based cements - Part 1: Powder/liquid acid-base cements
| Table 4: Summary of physical and chemical properties test | |||
|---|---|---|---|
| Item | Standard | Requirements | Conclusion |
| Components | ISO 9917-1:2007 | ||
| 5.2 Components | 5.2.1 Liquid | ||
| Free from deposits or filaments on the | |||
| inside of its container. | |||
| No visible signs of gelation. | |||
| 5.2.2 Powder | |||
| Free from extraneous material. If the | |||
| powder is coloured, the pigment shall be | |||
| uniformly dispersed throughout the | |||
| powder. | |||
| 5.3 Unset cement | |||
| Homogeneous and of a smooth | |||
| consistency. | Within spec | ||
| set by | |||
| standard | |||
| Net setting time | ISO 9917-1:2007 | ||
| 8.1 Net setting time | For restoration: 1.5~6min | Within spec | |
| set by | |||
| standard | |||
| Compressive | |||
| strength | ISO 9917-1:2007 | ||
| 8.3 Compressive strength | For restoration: ≥100MPa | Within spec | |
| set by | |||
| standard | |||
| Acid erosion | ISO 9917-1:2007 | ||
| 8.4 Acid erosion | ≤0.17mm | Within spec | |
| set by | |||
| standard | |||
| Acid-soluble | |||
| Lead content | ISO 9917-1:2007 | ||
| 8.6.2 Acid-soluble Lead | |||
| content | ≤100mg/kg | Within spec | |
| set by | |||
| standard | |||
| Radio- | |||
| opacity | ISO 9917-1:2007 | ||
| 8.7 Radio-opacity | The radio-opacity shall be at least | ||
| equivalent to that for the same thickness of | |||
| aluminium. | Within spec | ||
| set by | |||
| standard |
5
HUGE®
Shandong Huge Dental Material Corporation
www.hugedental.com T/+86 633 2277285 F/+86 633 2277298
No.68 Shanhai Road, Donggang District, Rizhao City
Shandong Province, 276800, P.R.China
echnological Characteristics
The new device has similar function, scientific concept, design, main materials and chemical composition as the predicate device
| Comparison Items | New Device | Primary Predicate Device | Reference Predicate Device | ||
|---|---|---|---|---|---|
| 1) | Regulatory Classifications | Glass Ionomer Cement (Filling) | |||
| 21 C.F.R. 872.3275 | |||||
| Product Code: EMA | |||||
| Class II | K980682 | ||||
| 21 C.F.R. 872.3275 | |||||
| Product Code: EMA | |||||
| Class II | K101869 | ||||
| 21 C.F.R. 872.3275 | |||||
| Product Code: EMA | |||||
| Class II | K161851 | ||||
| 21 C.F.R. 872.3275 | |||||
| Product Code: EMA | |||||
| Class II | |||||
| 2) | Intended Use- | ||||
| including the indications for use | Self-curing glass ionomer based radiopaque filling cement, for dental use only. | ||||
| (1) Restoration of primary teeth. | |||||
| (2) Restorations of Class III, V and limited Class I cavities. | |||||
| (3) Base linings under composite and amalgam. | |||||
| (4) Core build-up. | FUJI II is a self-cure glass ionomer material intended for the use as a dental restorative for the following typical applications: |
- Restoration of primary teeth.
- Core build-up.
- Class III, V and limited Class I cavities. | Refer to page 5-6 | Self-curing glass ionomer based radiopaque luting cement, for dental use only. Recommended indications:
(1) Cementation of metal-based inlays, onlays, crowns and bridges;
(2) Cementation of high strength (zirconia based) all ceramic crowns and bridges;
(3) Cementation of posts and screws made of metal or high-strength ceramic;
(4) Cementation of orthodontic bands;
(5) Restoration of caries in unstressed area (Luting II only). |
| 3) | Contraindications /Side Effects | 1. Pulp capping; - In rare cases the product may cause sensitivity in some people. If any such reactions are experienced, discontinue the use of the product and refer to a | 1. Pulp capping;
- In rare cases the product may cause sensitivity in some people. If any such reactions are experienced, discontinue the use of the product and | | 1. Pulp capping;
- In rare cases the product may cause sensitivity in some people. If any such reactions are experienced, discontinue the use of the product |
6
| Shandong Huge Dental Material Corp |
|---|
| www.hugedental.com T / +86 633 2277285 F / +86 633 |
HUGE®
No.68 Shanhai Road, Donggang District, Rizhao City,
Shandong Province, 276800, P.R.China
No.68 Shanhai Road, Donggang District, Rizhao City,
Shandong Province, 276800, P.R.China oration 3 2277298
| Comparison Items | New Device | Primary Predicate Device | Reference Predicate Device | |||
|---|---|---|---|---|---|---|
| Composition | ||||||
| of Materials | Glass Ionomer Cement (Filling) | K980682 | K101869 | K161851 | ||
| Mainly composed of powder: | ||||||
| Silica, Alumina, Strontium | ||||||
| Fluoride; Poly Carboxylic Acid | ||||||
| Mainly composed of liquid: | ||||||
| Poly Carboxylic Acid; Distilled | ||||||
| Water | Mainly composed of powder: | |||||
| Silica, Alumina, Strontium | ||||||
| Fluoride; Poly Carboxylic | ||||||
| Acid | ||||||
| Mainly composed of liquid: | ||||||
| Poly Carboxylic Acid; | ||||||
| Distilled Water | Mainly composed of | |||||
| powder: | ||||||
| Silica, Alumina, | ||||||
| Strontium Fluoride; | ||||||
| Poly Carboxylic Acid | ||||||
| Mainly composed of | ||||||
| liquid: | ||||||
| Poly Carboxylic Acid; | ||||||
| Distilled Water | Mainly composed of powder: | |||||
| Silica, Alumina, Strontium Fluoride; | ||||||
| Poly Carboxylic Acid | ||||||
| Mainly composed of liquid: | ||||||
| Poly Carboxylic Acid; Distilled | ||||||
| Water | ||||||
| Physical Properties | Filling I | Filling II | K980682 | K101869 | K161851 | |
| Items | Powder /liquid (g/g): | 1.8~2.0/1.0 | 2.0~2.1/1.0 | 2.7/1.0 | ||
| Mixing time (min., sec.): | min. 1'00" | min.1'00" | min.1'00" | |||
| Working time (min., sec.): | 1'00"~2'00" | 1'00"~2'00" | 1'45"~2'00" | Refer to page 5-7 | ||
| Net setting time (min., sec.): | 1'30"~6'00" | 1'30"~6'00" | 1'30"~6'00" | |||
| Compressive strength (MPa): | min.100 | min.100 | min.100 | |||
| Standards Met | ISO 9917-1:1991(E) | ISO 9917-1:2007; | ||||
| ISO 7405:2008; | ||||||
| ISO 10993-1:2009/(R) 2013; | ||||||
| ISO 10993-3:2014; | ||||||
| ISO 10993-5:2009/(R) 2014; | ISO 9917-1:2007; | |||||
| ISO 7405:2008; | ||||||
| ISO 10993-1:2009/(R) 2013; | ||||||
| ISO 10993-3:2014; | ||||||
| ISO 10993-5:2009/(R) 2014; | ||||||
| ISO 10993-10:2010; | ||||||
| ISO 10993-11:2006/(R) 2010; | ||||||
| ISO 14971:2007/(R) 2010; | ||||||
| ISO 15223-1:2012; | ||||||
| ISO 13485:2003 | ISO 9917-1:2007; | |||||
| ISO 7405:2008; | ||||||
| ISO 10993-1:2009/(R) 2013; | ||||||
| ISO 10993-3:2014; | ||||||
| ISO 10993-5:2009/(R) 2014; | ||||||
| ISO 10993-10:2010; | ||||||
| ISO 10993-11:2006/(R) 2010; | ||||||
| ISO 14971:2007/(R) 2010; | ||||||
| ISO 15223-1:2012; | ||||||
| ISO 13485:2003 | ||||||
| ISO 9917-1:2003 | ISO 10993-10:2010; | |||||
| ISO 10993-11:2006/(R) 2010; | ||||||
| ISO 14971:2007/(R) 2010; | ||||||
| ISO 15223-1:2012; | ||||||
| ISO 13485:2003 |
5-4
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Image /page/7/Picture/0 description: The image is a logo for a company called HUGE. The word "HUGE" is written in large, white letters on an orange oval background. To the right of the word "HUGE" are two small, white Chinese characters. The logo is simple and eye-catching.
Summary of Biocompatibility
The new device. Glass Ionomer Cement (Filling), is substantially equivalent to the predicate devices that have been on the market for decades and with no clinical adverse events. The formulation of new device does not contain any new or non-conventional chemicals compared to the legally marketed predicate device.
We selected our Glass Ionomer Cement (Filling II, shade: A3) as the representative model in biocompatibility tests because it is the worst case scenario. In the meantime, the two types of our Glass Ionomer Cement (Filling) has the same chemical compositions, indications for use, function mechanism and manufacturing process.
Biocompatibility tests were performed to satisfy the ISO 10993 standards. The test items include Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Subchronic Toxicity and Genotoxicity.
Summary of Substantial Equivalence
As with the comparison shown in substantial equivalence discussion, these devices are same or similar in almost all aspects. The new device adds an indication for use compared to the primary predicate device (Base linings under composite and amalgam) which fall within the indication for use of the reference predicate device (K101869, "Base/liner"). The details of physical properties are slightly different, but these devices are in equivalent to other legally marketed devices of this type.
It can be seen that the minor differences between the new device and the predicate device are not of significance. Shandong Huge Dental Material Corporation concludes that Glass Jonomer Cement (Filling) is substantially equivalent to the predicate device.
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Image /page/8/Picture/0 description: The image shows the word "HUGE" in white letters on an orange oval background. To the right of the word "HUGE" are two Chinese characters, also in white. The overall design is simple and eye-catching, with the bright orange color providing a strong contrast to the white text.
Photo of the device
Image /page/8/Picture/4 description: The image shows a dental cement kit by HUGE. The kit includes a box labeled "Glass Ionomer Cement (Filling) 1-1 PKG. Powder 15g Liquid 12g (10ml)", a bottle labeled "Glass Ionomer Cement (F) Powder 15g", a smaller bottle, a mixing pad, and a spatula. The box has text in multiple languages, including English, French, and Arabic.
Indications for use of the reference predicate device (K101869)
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 |
9
Image /page/9/Picture/0 description: The image features the word "HUGE" in bold, white letters against an orange, oval-shaped background. To the right of the word "HUGE" are two small Chinese characters, also in white. The overall design is simple and eye-catching, with the contrast between the white text and orange background making the word "HUGE" stand out.
Physical characteristics of the reference predicate device (K101869)
| | 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" | | | |
Physical characteristics of the reference predicate device (K161851)
| Items | Luting I | Luting II | Luting II
(only as restoration
materials) |
|--------------------------------|-------------|-------------|-------------------------------------------------|
| Powder /liquid (g/g): | 1.61.8/1.0 | 1.51.7/1.0 | 2.1~2.2/1.0 |
| Mixing time (min., sec.): | 45" | 45" | 45" |
| Working time (min., sec.): | ≤3'00" | 2'00"~3'00" | 1'30"~2'00" |
| Net setting time (min., sec.): | 1'30"~8'00" | 1'30"~8'00" | 1'30"~6'00" |
| Film thickness (μ m): | ≤25 | ≤25 | N/A |
| Compressive strength (MPa): | ≥50 | ≥50 | ≥100 |