(117 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical, chemical, and biocompatibility properties of a traditional glass ionomer cement, with no mention of AI or ML.
No.
The device is a dental luting cement used for affixing other dental devices and restoring caries, not a device directly used to treat or diagnose a disease or condition.
No
Explanation: The device is a luting cement used for affixing dental devices and restoring caries, which are treatment or restorative functions, not diagnostic ones. Its intended use and description do not mention any diagnostic capabilities.
No
The device description clearly states it is a "Glass Ionomer Cement" composed of physical materials (Silica, Alumina, Strontium Fluoride, Poly Carboxylic Acid) and operates based on an "acid-base reaction." This indicates a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: This device is a dental luting cement used to physically bond dental restorations (inlays, crowns, bridges, etc.) to teeth. It is a material used in the body (or on the teeth, which are part of the body), not a test performed on a sample taken from the body.
- Intended Use: The intended use clearly describes its function as a cement for affixing dental devices. It does not mention any diagnostic purpose or analysis of biological samples.
- Device Description: The description details the chemical composition and physical function of the cement, not a diagnostic test.
- Performance Studies: The performance studies focus on physical, chemical, and biocompatibility properties, which are relevant for a material used in the body, not for the accuracy of a diagnostic test.
Therefore, this device falls under the category of a dental material or device used for restoration and fixation, not an in vitro diagnostic.
N/A
Intended Use / 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).
Product codes
EMA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
on teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professional / used in hospital, dental clinic and relevant places
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 based on ISO 9917-1:2007 Dentistry-- Water-based cements - Part 1: Powder/liquid acid-base cements. Tests included: Components, Net setting time, Film thickness, Compressive strength, Acid erosion, Acid-soluble Lead content, and Radio-opacity. All results were within spec set by standard.
Biocompatibility tests were performed to satisfied 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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
1
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
2
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
4
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 per | ||
ISO 9917:2007 | Pass/fail criteria | Conclusion |
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. | ||
5.3 Unset cement | ||
Homogeneous and of a smooth consistency. | Within spec | |
set by | ||
standard | ||
ISO 9917-1:2007 | ||
8.1 Net setting time | For luting: 1.5~8 min | |
For restoration: 1.5~6 min | Within spec | |
set by | ||
standard | ||
ISO 9917-1:2007 | ||
8.2 Film thickness | For luting: ≤25 $ \mu $ m | |
For restoration: N/A | Within spec | |
set by | ||
standard | ||
ISO 9917-1:2007 | ||
8.3 Compressive strength | For luting: ≥50 MPa | |
For restoration: ≥100 MPa | Within spec | |
set by | ||
standard | ||
ISO 9917-1:2007 | ||
8.4 Acid erosion | For luting: ≤0.17 mm | |
For restoration: ≤0.17 mm | Within spec | |
set by | ||
standard | ||
ISO 9917-1:2007 | ||
8.6.2 Acid-soluble Lead | ||
content | For luting: ≤100 mg/kg | |
For restoration: ≤100 mg/kg | Within spec | |
set by | ||
standard | ||
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
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 I | ||||||
K980695 | |||||||
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 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 | |||||||
Items | Luting I | Luting II | Luting II | ||||
(only as restoration | |||||||
materials) | 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.): |