(91 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical and chemical properties of a dental resin cement, with no mention of AI or ML technologies.
No
The device is a dental luting cement used for cementing dental restorations, not for treating diseases or conditions.
No
Explanation: The device is a dental luting system (cement) used for the physical cementation of dental restorations. It does not perform any disease diagnosis or detection.
No
The device is a dental luting cement, which is a physical material (paste) used for bonding dental restorations. It is 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 use is for the cementation of dental restorations. This is a direct application within the body (or on a dental structure that is part of the body), not for testing samples taken from the body.
- Device Description: The description details a dental luting cement made of resins and fillers. This is a material used for bonding, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
The device is a dental material used for a restorative procedure, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Dual Cure Resin Cement is a dental luting system designed for cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers, dental posts and other restorations made from materials of metals/alloys, metal-ceramic and/or porcelain, composites, and their combinations.
Product codes (comma separated list FDA assigned to the subject device)
EMA, EBF
Device Description
Dual Cure Resin Cement is a versatile and ultimate dental dual cure (chemical and/or light cure) luting cement. This multi-purpose device is designed for cementation of all sorts of dental restorations made from materials of metal-ceramic, all-ceramic and/or porcelain, composites, and their combinations.
Dual Cure Resin Cement contains paste-paste of Base and Catalyst comprising primarily of dental methacrylate resins and inorganic fillers (with particle size range from about 0.01 - 3 microns and a filler volume of about 40%), inorganic pigments, photo-initiation and chemical curing systems. The mixing ratio, based on volume, is 1 part base paste : 1 part catalyst paste.
Dual Cure Resin Cement is delivered in either two seperated single syringe for Hand-mix and double-barrel syringes for Automix and comes in seven shades: TR (Translucent), A0 (Light+), A 1 (Light), A2 (Medium), A3 (Dark), White (White Opaque) and Opaque (Universal Opaque).
Dual Cure Resin Cement is radiopaque, allowing for easy identification on radiographs.
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
Prescription Use
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)
Dual Cure Resin Cement is classified as Type 2 Class 3 in accordance with ISO 4049, which belongs to luting materials that are cured by the application of external energy and also have a self-curing mechanism present ("dual cure" materials).
Test standards and methods based on ISO 4049:2009 and ISO 29022:2013:
| Items per ISO 4049: 2009/ISO 29022:2013 | Pass/fail criteria | Conclusion |
|---|---|---|
| ISO 4049: 2009 5.2.2 Film thickness, luting materials | The film thickness of luting materials in any event shall be no greater than 50 µm. | Satisfactory |
| ISO 4049: 2009 5.2.4 Working time, Class 1 and Class 3 luting materials | The material shall be capable of forming a thin layer; during its formation there shall be no detectable change in its homogeneity, shall be not less than 60 s. | Satisfactory |
| ISO 4049: 2009 5.2.6 Setting time, Class 3 materials | The setting time shall be not more than 10 min. | Satisfactory |
| ISO 4049: 2009 5.2.9 Flexural strength | The flexural strength shall be equal to or greater than 50 MPa. | Satisfactory |
| ISO 4049: 2009 5.2.10 Water sorption and solubility | The water sorption shall be =8 MPa (Internal standard) | Satisfactory |
Biocompatibility tests were performed fully following 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
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September 29, 2020
Maggie Zheng, Regulatory Affairs Manager Rizhao HuGe Biomaterials Company, Ltd. No.2 North Zhaoyang Road, District of Donggang Rizhao City. CHINA 276800 Shandong Province
Re: K201790
Trade/Device Name: Dual Cure Resin Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA, EBF Dated: July 17, 2020 Received: July 27, 2020
Dear Maggie Zheng:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K201790
Device Name Dual Cure Resin Cement
Indications for Use (Describe)
Dual Cure Resin Cement is a dental luting system designed for cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers, dental posts and other restorations made from materials of metals/alloys, metalceramic, all-ceramic and/or porcelain, composites, and their combinations.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| \u2713 |
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3
K201790
510 (k) Summary
This summary of 510(k) for the subjective device equivalence information is being submitted in accordance with the requirements of 21 C.F.R. 807.92.
-
- Date Summary Prepared: September 29, 2020
2. Submitter Information:
| Owner's Name | Rizhao HuGe Biomaterials Company, Ltd. |
|---|---|
| Address | No.2 North Zhaoyang Road, District of Donggang, Rizhao City, |
| Shandong Province, China 276800 | |
| Telephone | 0086 633 2277268 |
| Fax | 0086 633 2277298 |
| Contact Person | Ms. Maggie Zheng |
| Contact Title | Regulatory Affairs Manager |
| zhengxy@hugedent.com |
3. Device Name
Trade name: Dual Cure Resin Cement Common name: Dual Cure Resin Cement Classification name: Dental Cement (21 CFR 872.3275) Regulatory Class: II Product Code: EMA, EBF
4. Predicate Device Information
| Owner/Operator | Device Trade Name | 510 (k) No. | Product Code | Predicate |
|---|---|---|---|---|
| IVOCLAR VIVADENT AG | Multilink Automix | K123397 | EBF | Primary |
This predicate device has not been subject to a design-related recall.
No reference devices were used in this submission.
5. Description of Device
4
Dual Cure Resin Cement is a versatile and ultimate dental dual cure (chemical and/or light cure) luting cement. This multi-purpose device is designed for cementation of all sorts of dental restorations made from materials of metal-ceramic, all-ceramic and/or porcelain, composites, and their combinations.
Dual Cure Resin Cement contains paste-paste of Base and Catalyst comprising primarily of dental methacrylate resins and inorganic fillers (with particle size range from about 0.01 - 3 microns and a filler volume of about 40%), inorganic pigments, photo-initiation and chemical curing systems. The mixing ratio, based on volume, is 1 part base paste : 1 part catalyst paste.
Dual Cure Resin Cement is delivered in either two seperated single syringe for Hand-mix and double-barrel syringes for Automix and comes in seven shades: TR (Translucent), A0 (Light+), A 1 (Light), A2 (Medium), A3 (Dark), White (White Opaque) and Opaque (Universal Opaque).
Dual Cure Resin Cement is radiopaque, allowing for easy identification on radiographs.
6. Indications for Use
Dual Cure Resin Cement is a dental luting system designed for cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers, dental posts and other restorations made from materials of metals/alloys, metal-ceramic and/or porcelain, composites, and their combinations.
7. Summary of Physical and Chemical Properties Tests
Dual Cure Resin Cement is classified as Type 2 Class 3 in accordance with ISO 4049, which belongs to luting materials that are cured by the application of external energy and also have a self-curing mechanism present ("dual cure" materials).
Test standards and methods based on ISO 4049:2009 and ISO 29022:2013:
| ISO 4049: 2009 Dentistry - Polymer-Based Restorative Materials |
|---|
| ISO 29022:2013 Dentistry - Adhesive - Notched-edge shear bond strength test |
| Table 4: Summary of Physical and Chemical Properties Test | ||
|---|---|---|
| Items per | ||
| ISO 4049: 2009/ | ||
| ISO 29022:2013 | Pass/fail criteria | Conclusion |
| ISO 4049: 2009 | ||
| 5.2.2 Film thickness, luting | ||
| materials | The film thickness of luting materials in any event shall be | |
| no greater than 50 µm. | Satisfactory |
5
IHH
| ISO 4049: 2009
5.2.4 Working time, Class 1
and Class 3 luting materials | The material shall be capable of forming a thin layer;
during its formation there shall be no detectable change in
its homogeneity, shall be not less than 60 s. | Satisfactory |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| ISO 4049: 2009
5.2.6 Setting time, Class 3
materials | The setting time shall be not more than 10 min. | Satisfactory |
| ISO 4049: 2009
5.2.9 Flexural strength | The flexural strength shall be equal to or greater than 50
MPa. | Satisfactory |
| ISO 4049: 2009
5.2.10 Water sorption and
solubility | The water sorption shall be ≤ 40 µg/mm3.
The solubility of shall be ≤ 7.5 µg/mm3. | Satisfactory |
| ISO 4049: 2009
5.5 Radio-opacity | The radio-opacity shall be equal to or greater than that of
the same thickness of aluminium (1 mm of material). | Satisfactory |
| Shear bond strength
(The test method equal to the
ISO 29022:2013) | Shear bond strength for enamel and dentin≥8 MPa
(Internal standard) | Satisfactory |
8. Technological Characteristics
All components of the subject device are based upon industry well-known chemistry. The curing mechanism of the subject device and predicate devices are all of polymerization of uncured methacrylate ester monomers. The reaction is caused by photo initiator and chemical polymerization initiator systems. The following table shows the significant technological characteristics for the subject device and indicates the following similarities and differences with the predicate devices:
| Table 5: Technological Characteristics Comparison Table | ||
|---|---|---|
| Technological | ||
| Characteristics | Subject device | |
| (Dual Cure Resin Cement) | Primary predicate | |
| Monomer matrix | Methacrylate based | Methacrylate based |
| Primary Filler(s) | Silanated Barium glass filler | Silanated Barium glass filler |
| Physical Form | Pastes of Catalyst and Base | Pastes of Catalyst and Base |
| Indications of Use | Dual Cure Resin Cement is a dental luting | |
| system designed for cementation of all | ||
| sorts of dental restorations including | ||
| crowns, bridges, inlays/onlays, veneers, | ||
| dental posts and other restorations made | ||
| from materials of metals/alloys, | ||
| metal-ceramic, all-ceramic and/or | ||
| porcelain, composites, and their | ||
| combinations. | Multilink Automix is used for the permanent | |
| cementation of indirect restorations where a | ||
| strong bond us desired: |
- Inlays, onlays, crowns, bridges and root
posts made of:
● Metal and metal ceramics
● All-ceramics, in particular opaque
zirconium oxide ceramics
● Composites and fiber-reinforced
composites |
| Prescription/over-
the-counter use | Prescription | Prescription |
6
| Table 5: Technological Characteristics Comparison Table | ||
|---|---|---|
| Technological | ||
| Characteristics | Subject device | |
| (Dual Cure Resin Cement) | Primary predicate | |
| Curing method | Dual cure | Dual cure |
| Delivery form | Hand-mix / Automix | Automix |
| Radiographic | ||
| Appearance | Radiopaque | Radiopaque |
| Physical Properties | The subject device and the predicate devices have substantially equivalent physical | |
| properties as they all conform to the specifications set by ISO 4049 and ISO 29022. |
The subject device has the same technological characteristics as the predicate devices with the exception of the additional hand-mixing option. As compared to the predicated devices, the subject device is also available in Hand-mix, which is having the Catalyst and Base resin cement pastes packaged into physically separated single syringes instead of being packaged into a double barrel syringe as for the Automix. Regardless of which mode of operation by Hand-mix or Automix, the base and catalyst are mixed in a 1:1 ratio to form dual-curing cement, and it will not pose any new issues of the safety and effectiveness. Therefore, the minor differences in the delivery system affect neither the intended use nor substantial equivalence.
9. Summary of Biocompatibility
The new device, Dual Cure Resin Cement, is substantially equivalent to the predicate devices that have been legally marketed for decades and with no clinical adverse events. The formulation of new device does not contain any non-conventional chemicals compared to the legally marketed predicate device.
We selected our Dual Cure Resin Cement [Hand-mix, shade: Opague (Universal Opaque)] as the representative model in biocompatibility tests because it is the worst case scenario. In addition, the Hand-mix and Automix of our Dual Cure Resin Cement have the same chemical compositions, raw material suppliers, curing method and other technological characteristic.
Biocompatibility tests were performed fully following the ISO 10993 standards. The test items include Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Subchronic Toxicity and Genotoxicity.
10. Clinical Performance Data
Not applicable. Clinical performance testing has not been performed for the subject device.
11. Conclusions
Based on the indications for use, technological characteristics, performance testing and
7
HUGE
comparison to predicate devices, the subject device has been shown to be safe and effective for its intended use and the minor differences in indications for use fall within the intended use of the predicate devices affecting neither the general intended use nor substantial equivalence. Rizhao HuGe Biomaterials Company, Ltd. concludes that the subject device is substantially equivalent to the predicate devices described herein.