(323 days)
No
The device description and performance studies focus on the material properties and physical performance of a dental cement, with no mention of AI or ML technologies.
No
This device is a resin cement system used for the cementation of dental restorations, which is a structural rather than a therapeutic function.
No
Explanation: The device description and intended use clearly state that Allcem and Allcem Core are resin cements used for the cementation of tooth structures and indirect restorations. They are materials used for dental procedures, not for diagnosing conditions.
No
The device description clearly states the product is a "dual-curing radiopaque permanent resin cement system" composed of pastes and stored in a syringe, indicating it is a physical material, 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 the cementation of tooth structure and related dental restorations (crowns, bridges, posts, core build-up). This is a direct application to the patient's body for structural support and restoration, not for analyzing a sample taken from the body to diagnose a condition.
- Device Description: The device is a resin cement system composed of pastes with methacrylate monomers and other components. This is a material used for bonding and filling, not for performing a diagnostic test on a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
The device is clearly intended for use in dental procedures for restorative purposes, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Allcem and Allcem Core are indicated for the cementation of the tooth structure. It can be used for luting:
- Porcelain fused-to-metal crowns and bridges;
- Metal crowns, bridges, inlays and onlays (high noble, noble, and base metals);
- Crowns and bridges with minimal tooth structure;
- Maryland bridges (resin bonded bridges);
- All ceramic/porcelain and pre-cured composite crowns, bridges, inlays and onlays;
- Endodontic posts;
- Only for Allcem Core: Core build-up.
Product codes (comma separated list FDA assigned to the subject device)
EMA, EBF
Device Description
ALLCEM
Allcem is a dual-curing radiopaque permanent resin cement system indicated for the cementation of indirect restorations to the tooth structure. The product is composed of a base paste and a catalyst paste, stored in a double-body syringe, which allows releasinq the correct proportion of each paste (1:1) and separating syringes of base paste and catalyst paste. Allcem is composed of methacrylate monomers, such as TEGDMA and BisEMA, inorganic load, photoinitiators, coinitiators, catalysts and pigments. Allcem presents adjusted viscosity allowing the formation of fine layers of cement with the appropriate covering of the parts.
ALLCEM CORE
Allcem Core is a dual-curing resin cement specially conceived for the adhesive cementation of intraradicular posts, crowns and core build-up . The product is commercialized in a double-body syringe, which facilitates obtaining the correct mixing proportions of the two pastes (1:1), and eases clinical procedures. By using an self-mixing tip with an applying nozzle (intracanal tip), it is possible to apply the cement inside the root canal and easily cement the post. The same tip can be used to add material to the crown region of the post to build up the core, Allcem Core is a composite of methacrylate monomers such as BisGMA, BisEMA and TEGDMA, inorqanic load, photoinitiators, coinitiators, catalysts and pigments. The cement associates the necessary flow for applications in canals with the ideal thixotropy for core build-ups.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral, tooth
Indicated Patient Age Range
No restriction, it can be applied to general population
Intended User / Care Setting
Dental prosthetics and authorized laboratories and clinics.
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)
Non-clinical Testing was performed.
Key results are:
Flexing Resistance (dual cure): All results (CP 1: 143,71 MPa, CP 2: 159,21 MPa, CP 3: 135,61 MPa, CP 4: 145,08 MPa, CP 5: 143,51 MPa; Average: 145,4 MPa) are greater than the specified threshold of >=50MPa, therefore the material is considered as conformant.
Flexural strength - Chemical Curing: All results (CP 1: 135,1 MPa, CP 2: 103,6 MPa, CP 3: 139,4 MPa, CP 4: 137,6 MPa, CP 5: 123,0 MPa; Average: 127,7 MPa) are greater than the specified threshold of >=50MPa, therefore the material is considered to be in conformity.
Film Thickness: The film thickness is
§ 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.
November 2, 2019
Dentscare LTDA % Rodrigo Abreu Regulatory Specialist United Regulatory LLC 12343 NW 25th St Coral Springs, Florida 33065
Re: K183465
Trade/Device Name: Allcem, Allcem Core Regulation Number: 21 CFR 872.3275 Regulation Name: Dental cement Regulatory Class: Class II Product Code: EMA, EBF Dated: October 1, 2019 Received: October 4, 2019
Dear Rodrigo Abreu:
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
1
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 (OS) 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 mediation-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,
Srinivas Nandkumar, Ph.D. Acting 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
Indications for Use
510(k) Number (if known) K183465
Device Name Allcem and Allcem Core
Indications for Use (Describe)
Allcem and Allcem Core are indicated for the cementation of the tooth structure. It can be used for luting:
- · Porcelain fused-to-metal crowns and bridges;
- · Metal crowns, bridges, inlays and onlays (high noble, noble, and base metals);
- · Crowns and bridges with minimal tooth structure;
- · Maryland bridges (resin bonded bridges);
- · All ceramic/porcelain and pre-cured composite crowns, bridges, inlays and onlays;
- · Endodontic posts;
-
- Only for Allcem Core: Core build-up.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo of DentsCare. The logo consists of a stylized letter 'D' with three horizontal lines inside it, followed by the text 'DentsCare' in a sans-serif font. To the right of the logo, there is text indicating the address 'AV. EL' and 'SANTA', along with a phone number 'Ph: 55'.
AR NELSON MEISTER, 474, JOINVILLE, ARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
Image /page/3/Picture/2 description: The image shows the alphanumeric string 'K183465' in a bold, sans-serif font. The characters are black against a white background. The string appears to be a code or identifier, possibly a serial number or product key. The characters are evenly spaced and clearly legible.
Section 5
510(k) SUMMARY
October 2, 2019
A) Submitter's Name: DENTSCARE LTDA
Owner / Operator Registration Number: 3007210751
Manufacture Registration Number: 3007210751
- B) Address: AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL
- C) Phone and Fax Numbers
Phone: +55 (47) 34416131
D) Contact Person:
Roberta Uyara
Tel.: +55 (47) 34416131
- E) Preparation Date: October 2, 2019
- F) Classification Name: Dental cement.
Common / Usual Name: Dental cement
Proprietary Name: ALLCEM and ALLCEM CORE
Product Code: EMA
Class: Class II
Regulation: 21 CFR 872.3275
G) Device Description
ALLCEM
Allcem is a dual-curing radiopaque permanent resin cement system indicated for the cementation of indirect restorations to the tooth structure. The product is composed of a base paste and a catalyst paste, stored in a double-body syringe, which allows releasinq the correct proportion of each paste (1:1) and separating syringes of base paste and catalyst paste. Allcem is composed of methacrylate monomers, such as TEGDMA and BisEMA, inorganic load, photoinitiators, coinitiators, catalysts and pigments. Allcem presents adjusted viscosity allowing the formation of fine layers of cement with the appropriate covering of the parts.
ALLCEM CORE
Allcem Core is a dual-curing resin cement specially conceived for the adhesive cementation of intraradicular posts, crowns and core build-up . The product is commercialized in a double-body syringe, which facilitates obtaining the correct
4
Image /page/4/Picture/0 description: The image shows a logo for a dental care company called DentsCare. The logo features a stylized letter D with three horizontal lines inside it, followed by the company name "DentsCare" in a bold, slightly italicized font. To the right of the logo, there is text indicating the company's address and phone number, although the specific details are not fully legible.
CARF I TDA EDGAR NELSON MEISTER, 474, JOINVILLE, ATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
mixing proportions of the two pastes (1:1), and eases clinical procedures. By using an self-mixing tip with an applying nozzle (intracanal tip), it is possible to apply the cement inside the root canal and easily cement the post. The same tip can be used to add material to the crown region of the post to build up the core, Allcem Core is a composite of methacrylate monomers such as BisGMA, BisEMA and TEGDMA, inorqanic load, photoinitiators, coinitiators, catalysts and pigments. The cement associates the necessary flow for applications in canals with the ideal thixotropy for core build-ups.
H) Substantial Equivalence:
The ALLCEM and ALLCEM CORE is equivalent with the following product:
| 510(k) Number | Model | Company |
|---|---|---|
| K110508 | Suglue-10 | 3M Espe |
I) Reference Device:
| 510(k) Number | Model | Company |
|---|---|---|
| K060893 | Rebilda DC | VOCO GMBH |
5
Image /page/5/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter D with wave-like lines inside. The text includes the company name, address (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL), and phone number (Ph: 55 - 47 - 3441-6131).
J) Indications for Use:
| Indication for Use Comparison | ||
|---|---|---|
| Allcem and Allcem Core | Suglue-10 | Rebilda DC |
| Dentscare | 3M Espe | VOCO |
| Allcem and Allcem Core are indicated for | ||
| the cementation of indirect restorations of | ||
| the tooth structure. It can be used for | ||
| luting: | ||
| • Porcelain fused-to-metal crowns and | ||
| bridges; | ||
| • Metal crowns, bridges, inlays and onlays | ||
| (high noble, noble, and base metals); | ||
| • Crowns and bridges with minimal tooth | ||
| structure; | ||
| • Maryland bridges (resin bonded | ||
| bridges); | ||
| • All ceramic/porcelain and pre-cured | Final cementing of all-ceramic, | |
| composite, or metal inlays, onlays, | ||
| crowns and bridges; 2-3-unit Maryland | ||
| bridges and 3-unit inlay/onlay bridges | ||
| (excluded for patients with bruxism or | ||
| periodontitis) |
-
Final cementing of posts and screws
-
Final cementation of all-ceramic, or
composite veneers -
Final cementation of all-ceramic,
composite, or metal restorations on
implant abutments | Rebilda DC is a dual-curing, radiopaque,
flowable composite indicated for core
build-ups of vital and non-vital teeth. |
| composite crowns, bridges, inlays and
onlays;
• Endodontic posts;
- Only for Allcem Core: Core build-up. | | |
Discussion: The subject devices and predicate device have the same indication, are cements indicated for cementing intraradicular pins and indirect restorations (bridges, crowns, inlays, onlays and facets).
Both can be used with the following materials: metal, ceramics and resinous materials.
6
Image /page/6/Picture/0 description: The image shows the logo and contact information for Dentscare LTDA. The logo features a stylized letter D with horizontal lines inside. The text includes the company name, address (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL), and phone number (Ph: 55 - 47 - 3441-6131).
Regarding the claim core build-up indication, the Allcem Core is similar to the reference predicate, Rebilda DC.
K) Technological Characteristics Comparison:
The predicate device used to establish substantial equivalence for the ALLCEM CORE device is outlined below. This section of this submission will provide a comparison of design, materials, and technical specifications of the ALLCEM CORE to each of the predicate devices stratified by functional modality.
| Device Manufacturer | Allcem and Allcem Core | Suglue-10 | Rebilda DC | |
|---|---|---|---|---|
| and Common Name | Dentscare | 3M Espe | Voco | |
| 510k # | Not assigned yet | K110508 | K060893 | |
| Classification | Class II | Class II | Class II | |
| Regulation # | 21 CFR 872.3275 | 21 CFR 872.3275 | 21 CFR 872.3690 | |
| Product Code | EMA | EMA | EBF | |
| Classification Name | Dental cement | Dental cement | Tooth shade resin material. | |
| Patient Population | No restriction, it can be applied | |||
| to general population | No restriction, it can be applied | |||
| to general population | No restriction, it can be applied to | |||
| general population | ||||
| Prescription Use | RX only | RX only | RX only | |
| Environment | Dental prosthetics and | |||
| authorized laboratories and | ||||
| clinics. | ||||
| Allcem and Allcem Core must be | ||||
| stored in temperatures between | ||||
| 5° to 25°C | Dental prosthetics and | |||
| authorized laboratories and | ||||
| clinics. | ||||
| predicate must be stored in | ||||
| temperatures between 15° to | ||||
| 25°C | Dental prosthetics and authorized | |||
| laboratories and clinics. | ||||
| REBILDA DC must be stored in | ||||
| temperatures between 4° to 23°C | ||||
| Applicable Standards | ISO 4049; ISO 10993-1; ISO | |||
| 10993-5; ISO 10993-10 ISO | ||||
| 10993-11 | ISO 4049; ISO 10993-1; ISO | |||
| 10993-5; ISO 10993-10 ISO | ||||
| 10993-11 | ISO 4049; ISO 10993-1; ISO | |||
| 10993-10 | ||||
| Composition | Methacrylate monomers, | |||
| Radiopaque fillers, Initiator | ||||
| components, Stabilizers, | ||||
| Rheological additives, Pigments, | ||||
| Fluorescence dye, activator. | Methacrylate monomers, | |||
| Radiopaque fillers, Initiator | ||||
| components, Stabilizers, | ||||
| Rheological additives, Pigments, | ||||
| Fluorescence dye, activator. | Methacrylate monomers, | |||
| Radiopaque fillers, Initiator | ||||
| components, Stabilizers, | ||||
| Rheological additives, Pigments. | ||||
| Device Sterilization | Not Applicable | Not Applicable | Not Applicable | |
| How the device | ||||
| achieves its intended | ||||
| purpose | Fast light polymerization or long | |||
| working times in chemical | ||||
| curing Dual-curing materials | Fast light polymerization or long | |||
| working times in chemical curing | ||||
| Dual-curing materials | Fast light polymerization or long | |||
| working times in chemical curing | ||||
| Dual-curing materials | ||||
| Side effects | Systemic side effects are not | |||
| known to date. In allergic | ||||
| individuals, allergic reactions | ||||
| may occur. | Systemic side effects are not | |||
| known to date. In allergic | ||||
| individuals, allergic reactions | ||||
| may occur. | Systemic side effects are not | |||
| known to date. In allergic | ||||
| individuals, allergic reactions may | ||||
| occur | ||||
| Contra indications | ||||
| and Precautions | The product should not be used | |||
| in patients allergic to any of the | ||||
| substances contained in the | ||||
| formula. | ||||
| Wear protective gloves. | The product should not be used | |||
| in patients allergic to any of the | ||||
| substances contained in the | ||||
| formula. | ||||
| Wear protective gloves. | The product should not be used in | |||
| patients allergic to any of the | ||||
| substances contained in the | ||||
| formula. | ||||
| Primary Package | ||||
| Container | Syringe or Double Syringe | Double Syringe | Cartridges/Double Syringe (Quick | |
| mix syginge) | ||||
| Shelf life | 2 years | 18 months | 2 years | |
| Claims on product | Dual curing permanent adhesive | |||
| cementing system | Dual curing permanent adhesive | |||
| cementing system | Dual curing permanent adhesive | |||
| cementing system | ||||
| Use the same | ||||
| materials or | ||||
| substances in | ||||
| contact with the | ||||
| same human tissues | ||||
| or body fluids? | YES | YES | YES | |
| Is the product in | ||||
| compliance to | ||||
| EN ISO 10993 ? | YES | YES | YES | |
| Tissues | Enamel and Dentin | Enamel and Dentin | Enamel and Dentin | |
| Reusable | NO | NO | NO | |
| Duration | Permanent | Permanent | Permanent | |
| Part of body | Oral, tooth | Oral, tooth | Oral, tooth | |
| Is it used for the | ||||
| same clinical | ||||
| condition? | yes | yes | yes | |
| Is it used at the | ||||
| same site in the | ||||
| body? | yes | yes | yes | |
| Is it used in a similar | ||||
| population? | yes | yes | yes | |
| Is it used for the | ||||
| same intended | ||||
| purpose? | yes | yes | yes | |
| Is not foreseen to | ||||
| deliver significantly | ||||
| different | ||||
| performances? | no | no | no | |
| Is it similar | ||||
| conditions of use? | yes | yes | yes | |
| Is it similar | ||||
| specifications and | ||||
| properties | yes | yes | yes | |
| Is it similar | ||||
| principles of | ||||
| operation? | yes | yes | yes | |
| Film thickness | 8.8 µm | 8.4 µm | 14.4 µm | 18.6 µm |
| Working time | > 60 sec | > 60 sec | > 60 sec | > 60 sec |
| Setting time | 07:06 min | 07:18 min | 06:22 min | 06:40 min |
| Flexular strength | 127.7 MPa | 112.7 MPa | 105.9 MPa | 112.0 MPa |
| Water sorption | ||||
| solubility | 29.93 µg/mm³ | 28.37 µg/mm³ | 25.98 µg/mm³ | 26.59 µg/mm³ |
7
Image /page/7/Picture/0 description: The image shows the logo and contact information for Dentscare LTDA. The logo features a stylized letter D with wave-like lines inside it, accompanied by the text "DentsCare" in a smaller font. The contact information includes the company name, address (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL), and phone number (Ph: 55 - 47 - 3441-6131).
8
Image /page/8/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" with three horizontal lines inside it, followed by the text "DentsCare" in a sans-serif font. The logo is simple and modern, and the text is easy to read.
9
Image /page/9/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter "D" with three horizontal lines inside it, and the name "DentsCare" written below. The contact information includes the company name, address (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL), and phone number (Ph: 55 - 47 - 3441-6131).
| | Solubility:
5.62 µg/mm³ | Solubility:
5.57 µg/mm³ | Solubility:
5.54 µg/mm³ | Solubility:
5.00 µg/mm³ |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|----------------------------|----------------------------|
| Radio-opacity | 2.35 mm | 1.17 mm | 1.73 mm | 0.89 mm |
| Color
Color stability¹ | T0
L= 87.60
a= -0.97
b= 16.00
opac.= 48.0
T24
L= 85.42
a= -1.34
b= 19.96
opac.= 51.7 | T0
L= 85.80
a= -1.06
b= 16.17
opac.= 51.34
T24
L= 85.34
a= -0.89
b= 16.21
opac.= 52,30 | Not found | Not found |
| Shear Bond Strength | ISO 29022 specifies a shear test method used to determine the adhesive bond strength between
direct dental restorative materials and tooth structure.
The material is a direct restorative material, however, when it is used in contact with the tooth
structure, there is the necessity to use adhesive prior, so the contact is indirect. | | | |
4 The test where performed according to internal procedure (POPRD 0053) for stability test, so the results were obtained from stability tests of the products.
Discussion:
The subject device is similar to the predicate devices in that they are all dual-curing, radio-opaque resin cements to be used for permanently cementing restorations.
The subject device and the predicate devices have substantially equivalent of indications for use, shelf life, physical and mechanical properties. Despite differences in results, all products meet ISO 4049 and the requirements of this International Standard and it does not affect the substantial equivalence.
10
Image /page/10/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a muted blue-gray color. Three horizontal wavy lines are present within the upper portion of the "D", suggesting movement or flow. Below the symbol, the word "DentsCare" is written in a sans-serif font, also in the same muted blue-gray color.
NELSON MEISTER, 474, JOINVILLE, RINA 89219-501 BRAZIL - 3441-6131
L) Applicable Standard:
In order to reach substantially equivalent to the predicate device ALLCEM and ALLCEM CORE was developed, as well produced in compliance with recognized international regulations and standards for the medical device industry.
EN ISO 4049 Fourth edition 2009-10-01 - Dentistry - Polymer-based restorative materials - Recognition number: 4-181
ISO 10993-1 Fourth edition 2009-10-15 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process - Recognition number: 2-220
ISO 10993-10 Third Edition 2010-08-01 - Biological evaluation of medical devices --Part 10: Tests for irritation and skin sensitization - Recognition number: 2-174
ISO 10993-5 Third edition 2009-06-01 - Biological evaluation of medical devices --Part 5: Tests for in vitro cytotoxicity - Recognition number: 2-245
ISO 10993-11 Third edition 2017-09- Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity - Recognition number: 2-255
Conclusion:
Based on compliance with the international standard and regulation mentioned above, the device ALLCEM and ALLCEM CORE demonstrate equivalency to the predicates above.
11
Image /page/11/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter D with three horizontal lines inside it, along with the name "DentsCare" written below. The contact information includes the company's address on AV. EDGAR NELSON MEISTER, 474, in JOINVILLE, SANTA CATARINA 89219-501 BRAZIL. The phone number is listed as Ph: 55 - 47 - 3441-6131.
M) Non-clinical Testing:
In order to study the performance of the product, pre-clinical tests were performed according to the table below.
| Test | Specification | Results | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Flexing Resistance | |||||||||||||||||
| (dual cure) | According to the EN ISO 4049 standard the | ||||||||||||||||
| specification for flexural strength is ≥50MPa. | All results are greater than the specified | ||||||||||||||||
| threshold, therefore the material is considered | |||||||||||||||||
| as conformant. | |||||||||||||||||
| Corpo de prova | |||||||||||||||||
| Specimen Resultado | |||||||||||||||||
| Result CP 1 143,71 MPa CP 2 159,21 MPa CP 3 135,61 MPa CP 4 145,08 MPa CP 5 143,51 MPa Média/Average: 145,4 MPa | |||||||||||||||||
| Flexural strength - | |||||||||||||||||
| Chemical Curing | According to the EN ISO 4049 standard the | ||||||||||||||||
| specification for flexural strength is ≥50MPa. | All results are greater than the specified | ||||||||||||||||
| threshold, therefore the material is considered | |||||||||||||||||
| to be in conformity | |||||||||||||||||
| Corpo de prova/ | |||||||||||||||||
| Specimen Resultado/ | |||||||||||||||||
| Result Mpa CP 1 135,1 CP 2 103,6 CP 3 139,4 CP 4 137,6 CP 5 123,0 Média/Average: 127,7 | |||||||||||||||||
| Film Thickness. | According to the EN ISO 4049 standard the film | ||||||||||||||||
| thickness for cementing material should be less | |||||||||||||||||
| than 50 µm and also should not be 10 µm above | |||||||||||||||||
| any value declared by the manufacturer, so the | |||||||||||||||||
| company FGM - Dentscare does not declare the | |||||||||||||||||
| film thickness of the product in question (Allcem), | From the results obtained it is observed that | ||||||||||||||||
| the film thickness is ≤ 40 µm, thus complying | |||||||||||||||||
| with EN ISO 4049. |
The test was performed five times and the
samples showed the following results:
Reading B - Reading A = film thickness | | | | | | | | | | | | | | |
12
Image /page/12/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a gray color. Inside the "D", there are three horizontal wavy lines, also in gray, suggesting a sense of flow or movement. Below the "D", the word "DentsCare" is written in a sans-serif font, with the first letter capitalized and the rest in lowercase.
| | so the result of acceptance must be less than 50 μm | Sample 1: 10.218mm - 10.187mm = 0.031 mm = 31 μm
Sample 2: 10.244mm - 10.208mm = 0.036mm = 36 μm
Sample 3: 10.222mm - 10.184mm = 0.038mm = 38 μm
Sample 4: 10.223mm - 10.191mm = 0.032mm = 32 μm
Sample 5: 10.239mm - 10.204mm = 0.035mm = 35 μm |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Working time. | According to the EN ISO 4049 standard, the working time for cementing materials must be at least 60 seconds. | The results demonstrate that the product has a working time greater than 60 seconds. Ideal time for the work of the professional and within the value established by the Standard. |
| Setting Time | According to the EN ISO 4049 standard, the setting time for the cement material must be a maximum of 10 minutes. | From the results it is observed that the setting time of the material is around 7 minutes, thus meeting the specification in the EN ISO 4049 standard. |
| Water sorption and solubility. | Sorption: Maximum of 40 µm/mm³.
Solubility: maximum of 7.5 µm/mm³. | The results demonstrate that the Allcem product complies the specification in the EN ISO 4049 Standard. |
| Radiopacity | The opacity value (equivalent to aluminum) of a specimen with 1.0 mm thickness is given by δα/δss.
If this value is ≥ 1 mm, the material will be in accordance with the first requirement where:
If the manufacturer declares that the material is radiopaque, the radiopacity must be of a thickness greater than or equal to the aluminum material and should not be 0.5 mm above any value declared by the manufacturer. | The values found in the specimens are between the second and third scale of the aluminum part, proving that the material is radiolucent according to the requirements of ISO 4049. |
13
Image /page/13/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a muted blue-gray color. Three horizontal wavy lines are embedded within the upper part of the "D", suggesting movement or flow. Below the "D", the word "DentsCare" is written in a sans-serif font, also in the same muted blue-gray color.
| Accelerated
Stability Studies | to accelerate the possible
Study
created
chemical degradation and/or physical changes of
the ALLCEM product in forced conditions of
storage. | Considering the results observed at the end of
the 129 days test period, the shelf-life of 2
years in the storage condition of 25 °C for the
Allcem product can be confirmed. | |
|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Evaluation Report
of Long-Term
Stability (Shelf) | Study designed to verify the physical and
chemical characteristics of the product ALLCEM
during the expected shelf life. The results are
used to confirm the expiration date and storage
conditions. | Considering the results observed at the end of
the 24 months of the long-term test (shelf), the
shelf life of 2 years in the storage condition of
25°C for the Allcem product can be confirmed. | |
| Adhesive
resistance to metal
surfaces, pins,
ceramics and
laboratory resin. | Near or higher than competitors. | Although it is not a standard assay and the
adhesion to the dental structure is promoted by
adhesives, these tests demonstrate that
Allcem has excellent adhesion results. | |
| Shear bond
strength (per ISO
29022) | ISO 29022 specifies a shear test method used to determine the adhesive bond strength between
direct dental restorative materials and tooth structure.
The material is a direct restorative material, however, when it is used in contact with the tooth
structure, there is the necessity to use adhesive prior, so the contact is indirect. | | |
Conclusion: Based on the performance test applied to this ALLCEM and ALLCEM CORE and the predicates comparison, we conclude that the performance and effectiveness for the specified indications for use for these products were reached as well the substantially equivalency with the predicates.