(117 days)
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).
Glass Ionomer Cement (Luting) has two models: Luting II. It is a device composed of various materials mainly including Silica, Alumina, Strontium Fluoride in the powder composition and Poly Carboxylic Acid in the liquid composition which intended to serve as luting to affix dental devices such as metal-based inlays, onlays, crowns, bridges, and orthodontic bands. It's a powder liquid system, with each part is packaged separately when not in use. The basic operation principle of Glass Ionomer Cement (Luting) is acid-base reaction.
The provided document is a 510(k) summary for a "Glass Ionomer Cement (Luting)" device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on algorithm-driven performance. Therefore, most of the requested information about AI/algorithm-related studies (sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance) is not applicable to this document.
However, the document does contain a table of acceptance criteria and reported performance for physical and chemical properties based on the ISO 9917-1:2007 standard.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Item per ISO 9917-1:2007 | Acceptance Criteria (Pass/fail criteria) | Reported Device Performance (Conclusion) |
|---|---|---|
| 5.2 Components | - Liquid: Free from deposits or filaments on the inside of its container. No visible signs of gelation.- Powder: Free from extraneous material.- Unset cement: Homogeneous and of a smooth consistency. | Within spec set by standard |
| 8.1 Net setting time | - For luting: 1.5 | Within spec set by standard |
| 8.2 Film thickness | - For luting: ≤25 µm- For restoration: N/A | Within spec set by standard |
| 8.3 Compressive strength | - For luting: ≥50 MPa- For restoration: ≥100 MPa | Within spec set by standard |
| 8.4 Acid erosion | - For luting: ≤0.17 mm- For restoration: ≤0.17 mm | Within spec set by standard |
| 8.6.2 Acid-soluble Lead content | - For luting: ≤100 mg/kg- For restoration: ≤100 mg/kg | Within spec set by standard |
| 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 |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each physical/chemical property test. It mentions that "Biocompatibility tests were performed to satisfied the ISO 10993 standards," but does not detail the specific sample counts for those tests. The data provenance is internal testing conducted by SHANDONG HUGE DENTAL MATERIAL CORPORATION, presumably prospective testing for this specific device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests are for physical and chemical properties, measured objectively according to ISO standards, not interpreted by human experts.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements, not subject to 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 is a dental cement, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a dental cement, not an algorithm.
7. The type of ground truth used
The "ground truth" for the physical and chemical property tests is defined by the specific measurement methodologies and acceptable ranges stipulated in the ISO 9917-1:2007 standard. For biocompatibility, the ground truth would be the thresholds and methodologies defined by ISO 10993 standards.
8. The sample size for the training set
Not applicable. There is no AI algorithm being trained.
9. How the ground truth for the training set was established
Not applicable. There is no AI algorithm being trained.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a way that resembles a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 31, 2016
Shandong Huge Dental Material Corporation Steven Song General Manager No. 68 Shanhai Road, Donggang District Rizhao City, 276800 REPUBLIC OF CHINA
Re: K161851
Trade/Device Name: Glass Ionomer Cement (Luting) Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: July 6, 2016 Received: July 6, 2016
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
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the quality systems (OS) 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 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,
Susan Runne, DDS, MA
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
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Indications for Use
510(k) Number (if known)
Device Name
Glass Ionomer Cement (Luting)
Indications for Use (Describe)
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).
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Residential Use For A CEEP, AMI, Solar or Pilot | One-Time Support Handling CEEP |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------ | -------------------------------------------------------------------------------------------------------------------------- |
|× | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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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.
510 (k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R. 807.92.
-
- Date Summary Prepared: Aug. 01, 2016
2. 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 |
3. Device Name
Trade name: Glass Ionomer Cement (Luting) Common name: Glass Ionomer Cement Classification name: Dental Cement
4. Substantially Equivalent Device
| Table 2: Predicate Device Information | |||
|---|---|---|---|
| Company Name | Device Name | 510 (k)NO. | Substantially Equivalent(SESE) Decision Date |
| GC AMERICA, INC. | FUJI I | K980695 | 04/13/1998 |
No reference devices were used in this submission.
5. Description of Device
Glass Ionomer Cement (Luting) has two models: Luting II. It is a device composed of various materials mainly including Silica, Alumina, Strontium Fluoride in the powder composition and Poly Carboxylic Acid in the liquid composition which intended to serve as luting to affix dental devices such as metal-based inlays, onlays, crowns, bridges, and orthodontic bands. It's a powder liquid system, with each part is packaged separately when not in
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Image /page/4/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. The word "HUGE" is in a sans-serif font and is the most prominent element in the image. The orange oval shape provides a contrasting background that makes the text stand out.
use. The basic operation principle of Glass Ionomer Cement (Luting) is acid-base reaction.
The physical properties of Glass Ionomer Cement (Luting) see page 5-3.
6. Indications for use
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).
7. 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 3: Summary of physical and chemical properties test | ||
|---|---|---|
| Items perISO 9917:2007 | Pass/fail criteria | Conclusion |
| ISO 9917-1:20075.2 Components | 5.2.1 LiquidFree from deposits or filaments on the inside of its container.No visible signs of gelation.5.2.2 PowderFree from extraneous material.5.3 Unset cementHomogeneous and of a smooth consistency. | Within specset bystandard |
| ISO 9917-1:20078.1 Net setting time | For luting: 1.5 | Within specset bystandard |
| ISO 9917-1:20078.2 Film thickness | For luting: ≤25 $ \mu $ mFor restoration: N/A | Within specset bystandard |
| ISO 9917-1:20078.3 Compressive strength | For luting: ≥50 MPaFor restoration: ≥100 MPa | Within specset bystandard |
| ISO 9917-1:20078.4 Acid erosion | For luting: ≤0.17 mmFor restoration: ≤0.17 mm | Within specset bystandard |
| ISO 9917-1:20078.6.2 Acid-soluble Leadcontent | For luting: ≤100 mg/kgFor restoration: ≤100 mg/kg | Within specset bystandard |
| ISO 9917-1:20078.7 Radio-opacity | The radio-opacity shall be at least equivalent to that for thesame thickness of aluminium. | Within specset bystandard |
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Image /page/5/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. The word "HUGE" is in a bold, sans-serif font. The orange oval is slightly tilted to the left.
8. Technological Characteristics:
The new device, Glass Ionomer Cement (Luting), has the same design, materials and chemical composition as the predicate device.
| Comparison Items | New Device | Predicate Device | |||||
|---|---|---|---|---|---|---|---|
| Glass Ionomer Cement (Luting) | FUJI IK980695 | ||||||
| 1) | Regulatory Classifications | same | same | ||||
| 2) | Indications for use | similar | similar | ||||
| 3) | Contraindications | same | same | ||||
| 4) | Composition of Materials | Mainly composed of powder:Silica, Alumina, Strontium Fluoride;Poly Carboxylic AcidMainly composed of liquid:Poly Carboxylic Acid; Distilled Water | Mainly composed of powder:Silica, Alumina, Strontium Fluoride;Poly Carboxylic AcidMainly composed of liquid:Poly Carboxylic Acid; Distilled Water | ||||
| Items | Luting I | Luting II | Luting II(only as restorationmaterials) | FUJI I | |||
| 5) | Physical Properties | Powder /liquid (g/g): | 1.6~1.8/1.0 | 1.5~1.7/1.0 | 2.1~2.2/1.0 | 1.8/1.0 | |
| Mixing time (min., sec.): | 45" | 45" | 45" | 20" | |||
| Working time (min., sec.): | <3'00" | 2'00"~3'00" | 1'30"~2'00" | 2'00" | |||
| Net setting time (min., sec.): | 1'30"~8'00" | 1'30"~8'00" | 1'30"~6'00" | 4'30" | |||
| Film thickness (μ m): | ≤25 | ≤25 | N/A | ≤25 | |||
| Compressive strength (MPa): | ≥50 | ≥50 | ≥100 | ≥50 | |||
| 6) | Labeling | similar | similar | ||||
| 7) | Target Population | dental patients | dental patients | ||||
| 8) | Anatomical Site | on teeth | on teeth | ||||
| 9) | Where Used | used in hospital, dental clinic andrelevant places | used in hospital, dental clinic andrelevant places | ||||
| 10) | Human Factors | dental professional | dental professional | ||||
| 11) | Design | powder, liquid, powder scoop, mixingpads; acid-base reaction | powder, liquid, powder scoop, mixingpads; acid-base reaction | ||||
| 12) | Stability/Shelf Life | Storage: Store in a cool and dark place(4-25°C) (39.2-77.0°F).Shelf life: 2 years | Storage: Store in a cool and darkplace (4-25°C) (39.2-77.0°F).Shelf life : 3 years | ||||
| 13) | Cautions | similar | similar | ||||
| 14) | Standards Met | similar | similar | ||||
| 15) | Biocompatibility | same | same | ||||
| 16) | Sterility | clean not sterile | clean not sterile | ||||
| 17) | Chemical Safety | similar | similar |
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Image /page/6/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 stacked on top of each other. The orange oval is slightly tilted to the left.
9. Summary of Biocompatibility
The new device, Glass Ionomer Cement (Luting), is substantially equivalent to the predicate devices (K980695) 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 and those biocompatibility test reports can be used in the biological evaluation of Glass Ionomer Cement (Luting). The main reason is that Glass Ionomer Cement (Luting) has the same chemical compositions of glass powder, raw material suppliers, function mechanism and manufacture process as Glass Ionomer Cement ( Filling II, shade: A3).
Biocompatibility tests were performed to satisfied the ISO 10993 standards. The test items include Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Subchronic Toxicity and Genotoxicity.
10. Summary of Substantial Equivalence
As with the comparison shown in substantial equivalence discussion, these two devices are similar in almost all aspects. In addition, the new device adds indications for use compared to the predicate device, the minor differences in indications for use fall within the intended use of the predicate device and do not impact safety and effectiveness proved by the tests. The details of physical properties are slightly different, but these two devices are in equivalent to other legally marketed devices of this type. Regarding the shelf life, the performance of the new device is not adversely affected by aging in 3.5 years. In order to ensure the quality of products, we have choose 2 years as the shelf life for Glass Ionomer Cement (Luting).
It can be seen that the minor differences between the new device and the predicate device are not of significance and do not raise questions of safety and effectiveness as compared to the predicate device. SHANDONG HUGE DENTAL MATERIAL CORPORATION concludes that Glass Ionomer Cement (Luting) is substantially equivalent to the predicate device described herein.
11. Photo of the device
The photo of the new device is presented in the following page.
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Image /page/7/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. The word "HUGE" is in a bold, sans-serif font. The orange oval is slightly tilted to the left.
Image /page/7/Picture/3 description: The image shows a dental product called "HUGE Glass Ionomer Cement (Luting)". The product comes in a box that contains a powder and a liquid. The box indicates that the powder is 30g and the liquid is 25g (21ml). The image also shows the powder and liquid in separate containers, along with a mixing pad and spatula.
§ 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.