(269 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a dental cement, with no mention of AI or ML technologies.
No.
The device is a dental cement used for luting various dental restorations and orthodontic appliances, which are typically considered restorative or prosthetic procedures, not therapeutic in the sense of directly treating a disease or dysfunction.
No
The device is a self-adhesive resin cement used for luting (bonding) various dental restorations and appliances. It performs a therapeutic/restorative function rather than a diagnostic one.
No
The device description clearly states it is a "dual-cured self-adhesive resin cement," which is a physical material, not software. The performance studies also focus on material properties and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to the cementation of dental restorations and appliances within the mouth. This is a direct application to the patient's body for structural support and attachment.
- Device Description: The device is described as a "dual-cured self-adhesive resin cement," which is a material used for bonding.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device is clearly intended for in vivo (within the body) use as a dental cement.
N/A
Intended Use / Indications for Use
-
- Luting metal crowns, bridge, inlay and including porcelain-fused-to-metal and composite-to-metal varieties
-
- Luting resin crowns, bridges, inlays, onlays and veneers
-
- Luting metal or non-metal/fiber posts
-
- Luting orthodontic appliances
-
- Luting porcelain inlays, onlays, crowns and veneers (includes alumina and zirconia)
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
The U-Cem™ Premium and the MAZIC® Cem are dual-cured self-adhesive resin cement. The U-Cem™ Premium and the MAZIC® Cem are the same product yet with different label design for different volume packages. The brand name, MAZIC® Cem, is specifically for 8.5g. It is fluoride-releasing paste type, and has radiopaque. U-Cem™ Premium is available in both Automix and Double Dispenser types, and offers three different shades: Clear, Universal, and Opaque for esthetics. It is used for cementation of ceramics, metals or composite inlays, onlays, crowns, bridges, posts and screws.
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 / Hospital
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)
Performance Tests (Non-clinical):
- ISO 4049 Fourth edition 2009-10-01 Dentistry Polymer-based restorative materials
- ISO 9917-1 Second edition 2007-10-01 Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements, Annex D.
- ISO /TS 11405 Third edition 2015-02-01 Dentistry - Testing of adhesion to tooth i structure
Biocompatibility Tests:
- ISO 10993-1 Fourth edition 2009-10-15, biological evaluation of medical devices part 1: evaluation and testing within a risk management process [including: technical corrigendum 1 (2010)]. (Biocompatibility)
- ISO 10993-3 Third edition 2014-10-1 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization
- ISO 10993-11 Second edition 2006-08-15 Biological evaluation of medical devices -Part 11: Tests for systemic toxicity
Shelf Life Test:
- Performance Tests in accordance with ISO 4049 and ISO 9917-1.
Key Results: The test results of non-clinical tests performed on the subject device supported that it is substantially equivalent to the predicate devices despite the differences.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Working Time (at 60sec. after completion of mixing): Physically homogeneous and forming the thin layer
Setting time: 2 m 12s
Compressive strength: 236.35MPa
Flexural strength: 135.87MPa
Film thickness: 11 µm
Shear bond strength:
Composite - Dentin: 12.85MPa
Composite - Enamel: 19.16MPa
Glass Ceramic - Litium disilicate: 6.21MPa
Ceramic Aluminum oxide: 7.28MPa
Metal: 12.70MPa
Zirconia: 9.05MPa
Fluoride release: 2.42 ppm
Radio-opacity: 1.45
Solubility: 0.87 µg/mm²
Polymerization shrinkage: 4.38%
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.
Not Found
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 21, 2020
Vericom Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc 1150 Roosevelt, STE 200 Irvine, California 92620
Re: K193260
Trade/Device Name: U-Cem Premium & MAZIC Cem Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: July 21, 2020 Received: July 24, 2020
Dear Priscilla Chung:
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.
1
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 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-reportingcombination-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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193260
Device Name
U-Cem™ Premium & MAZIC® Cem
Indications for Use (Describe)
-
- Luting metal crowns, bridge, inlay and including porcelain-fused-to-metal and composite-to-metal varieties
-
- Luting resin crowns, bridges, inlays, onlays and veneers
-
- Luting metal or non-metal/fiber posts
-
- Luting orthodontic appliances
-
- Luting porcelain inlays, onlays, crowns and veneers (includes alumina and zirconia)
| 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) |
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3
510(k) Summary (K193260)
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: July 16, 2020
1. 510K Applicant / Submitter:
Vericom Co., Ltd. 48.Toegyegongdan 1-Gil, Chuncheon-Si, Gangwon-Do, 200-944, Republic of Korea Tel: +82-31-441-2881 Fax: +82-31-441-2883
2. Submission Contact Person
LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200, Irvine CA 92620 Priscilla Juhee Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c(@lkconsultinggroup.com
3. Device
- Proprietary Name: U-Cem™ Premium & MAZIC® Cem .
- Common Name: Luting Cement .
- Classification: Dental Cement, Class II (21 CFR 872.3275) .
- . Product Code: EMA
4. Predicate Device
BisCem (K082449) by Bisco, Inc.
5. Description:
The U-Cem™ Premium and the MAZIC® Cem are dual-cured self-adhesive resin cement. The U-Cem™ Premium and the MAZIC® Cem are the same product yet with different label design for different volume packages as shown below. The brand name, MAZIC® Cem, is specifically for 8.5g.
It is fluoride-releasing paste type, and has radiopaque. U-Cem™ Premium is available in both Automix and Double Dispenser types, and offers three different shades: Clear, Universal, and Opaque for esthetics.
4
It is used for cementation of ceramics, metals or composite inlays, onlays, crowns, bridges, posts and screws.
8. Indications for Use
- Luting metal crowns, bridge, inlay and including porcelain-fused-to-metal and compositeto-metal varieties
-
- Luting resin crowns, bridges, inlays, onlays and veneers
-
- Luting metal or non-metal/fiber posts
-
- Luting orthodontic appliances
-
- Luting porcelain inlays, onlays, crowns and veneers (includes alumina and zirconia)
9. Substantial Equivalence Discussion:
The U-Cem™ Premium/ the MAZIC® Cem has the same intended use and the principle of operation, and also has similar physical properties demonstrating comparable performance specifications to the predicate device: BisCem (K082449) by Bisco, Inc.
The Indications for Use statement of the subject device is similar to that of the predicate device, but it is described in a slightly different way. However, fundamentally the predicate device's indications cover the subject device's claims.
One of the differences is the subject device has an additional delivery system which is the Double Dispenser type. This Double Dispenser has the same mixing ration as the auto mix type so this difference does not raise a question in substantial equivalence.
Another difference is that the subject device has three shades, whereas, the BisCem has two shades, and some raw materials used might be different. However, bench performance and biocompatibility testing performed demonstrates that these differences would not raise a new question in substantial equivalence. For the tests that were performed according to the standards, both devices satisfied the standards' requirements. For the testing that does not have an international standard, the test results of the subject device were substantially equivalent to the predicate device.
The Physical and Performance properties are also very similar except setting time. The subject device shows faster setting time which is 2 minutes and 12 seconds. Both devices meet the ISO 4049 requirement for the setting time, and it does not a raise an issue to support substantial equivalence.
Based on the information provided herein, it is concluded that the U-Cem™ Premium/ the MAZIC® Cem is substantially equivalent to the predicate device.
| Subject Device | Predicate Device | |
|---|---|---|
| Device Name | U-Cem™ Premium | BisCem |
| 510k # | K193260 | K082449 |
| Manufacturer | VERICOM CO., LTD. | Bisco, Inc. |
5
| Indications for use | | 1. Luting metal crowns, bridge, inlay and including porcelain-fused-to-metal and composite-to-metal varieties
2. Luting resin crowns, bridges, inlays, onlays and veneers
3. Luting metal or non-metal/fiber posts
4. Luting orthodontic appliances
5. Luting porcelain inlays, onlays, crowns and veneers (includes alumina and zirconia) | 1. Luting metal crowns, bridge, inlay and including porcelain-fused-to-metal and composite-to-metal varieties
2. Luting resin crowns, bridges, inlays, onlays and veneers
3. Luting metal or non-metal/fiber posts
4. Luting orthodontic appliances
5. Luting porcelain inlays, onlays, crowns and veneers (includes alumina and zirconia) | |
|-----------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Principle of operation | | Dual cured | Dual cured | |
| Physical &
Performance
properties | Working Time
(at 60sec. after
completion of
mixing) | Physically homogeneous and forming the thin layer | Physically homogeneous and forming the thin layer | |
| | Setting time | 2 m 12s | 9 m 08 s | |
| | Compressive strength | $236.35MPa$ | $189.15MPa$ | |
| | Flexural strength | $135.87MPa$ | $101.93 MPa$ | |
| | Film thickness | $11 μm$ | $23 μm$ | |
| | Shear
bond
strength | Composite -Dentin | $12.85MPa$ | $7.68MPa$ |
| | | Composite -Enamel | $19.16MPa$ | $16.32MPa$ |
| | | Glass Ceramic -Litium disilicate | $6.21MPa$ | $5.49MPa$ |
| | | Ceramic Aluminum oxide | $7.28MPa$ | $4.27MPa$ |
| | | Metal | $12.70MPa$ | $4.38MPa$ |
| | | Zirconia | $9.05MPa$ | $5.12MPa$ |
| | Fluoride release | | $2.42 ppm$ | $10.02 ppm$ |
| | Radio-opacity | | 1.45 | None |
| | Solubility | | $0.87 µg/mm²$ | $1.53µg/mm²$ |
| | Polymerization shrinkage | | 4.38% | 4.18% |
| Chemical
Composition | Filler | | Amorphous silica | Amorphous silica |
| | Resin composition | | Methacrylate based | Methacrylate based |
| | Method of application
Ions released | | Bonding agent not required
Fluoride | Bonding agent not required
Fluoride |
| Standard Conformed | | ISO 4049 | ISO 4049 | |
| Biocompatibility | | Yes | Yes | |
| Use | | Prescription / Hospital | Prescription / Hospital | |
| Delivery system | | Dual syringe(Base:Catalyst=1:1), Automix and Double Dispenser type | Dual-syringe(Base:Catalyst=1:1), Automix type | |
| Storage condition | | 28°C8°C
(at refrigerator temperature) | 2
(at refrigerator temperature) | |
6
| Physical
properties | Shade | - Clear
- Universal
- Opaque | - Translucent
- Opaque |
|------------------------|-------|------------------------------------|---------------------------|
|------------------------|-------|------------------------------------|---------------------------|
10. Performance Tests (Non-clinical)
-
. Performance Test:
- ISO 4049 Fourth edition 2009-10-01 Dentistry Polymer-based restorative materials
-
ISO 9917-1 Second edition 2007-10-01 Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements, Annex D.
ISO /TS 11405 Third edition 2015-02-01 Dentistry - Testing of adhesion to tooth i structure
- Biocompatibility Tests ●
- ISO 10993-1 Fourth edition 2009-10-15, biological evaluation of medical devices part 1: evaluation and testing within a risk management process [including: technical corrigendum 1 (2010)]. (Biocompatibility)
- ISO 10993-3 Third edition 2014-10-1 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization
- ISO 10993-11 Second edition 2006-08-15 Biological evaluation of medical devices -Part 11: Tests for systemic toxicity
- Shelf Life Test Performance Tests in accordance with ISO 4049 and ISO 9917-1 .
The test results of non-clinical tests performed on the subject device supported that it is substantially equivalent to the predicate devices despite the differences.
11. Conclusions:
Based on the information provided in this premarket notification, Vericom Co., Ltd. concludes that the U-Cem™ Premium & MAZIC® Cem is substantially equivalent to the predicate device as described herein in.