(367 days)
- All classes of direct restoration with composites (class I, II, III, IV and V);
- Adhesive luting (in addition to resin cement) of prosthetic pieces (post/cores, crowns, onlays/inlays, veneers etc.) made of fiberglass, ceromer, ceramic, resin and metal;
- Adhesive repairs in ceramic and composites.
*Only for Ambar Universal APS: Use as metallic or ceramic primer.
Ambar APS is a light-curing 5th generation adhesive (two-step adhesive, total etch technique) for bonding restorative materials to dental tissue (enamel and/ or dentin). As the primer and the bonding agent are combined in a single bottle, acid etching is the only previous step needed before applying the adhesive to dentin and enamel.
Ambar Universal APS is a single flask self-etch light-curing adhesive system (Seventh Generation) responsible for the union between tooth structure (enamel and dentin) and restorative materials. The primer and bonding agent are combined in a single flask. Prior use of acid etchant is optional on both tooth 's enamel and dentin, it can be used, therefore, in three ways: self-etch, selective-etch and total-etch.
This document, a 510(k) premarket notification from the FDA, describes DentsCare LTDA's dental bonding agents (Ambar APS and Ambar Universal APS) and their substantial equivalence to predicate devices. The listed information pertains to the non-clinical testing conducted to demonstrate the device's performance characteristics, not a human-in-the-loop AI study. Therefore, sections related to multi-reader multi-case (MRMC) comparative effectiveness, number of experts for ground truth, adjudication methods, or training set details are not applicable here.
The study proves the device meets acceptance criteria through a series of physical and chemical tests comparing the subject devices to internationally recognized commercial adhesives (predicates).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test are explicitly stated as "if the adhesive under study has a mean $\ge$ than the competing adhesives analyzed," or similar comparative statements.
| Test | Acceptance Criteria | Reported Device Performance (Ambar APS $\pm$ SD) | Reported Device Performance (Ambar Universal APS $\pm$ SD) | Performance of Predicate Devices (Range or Avg $\pm$ SD) |
|---|---|---|---|---|
| Adhesive Strength (MPa) | Mean $\ge$ competing adhesives | $38.61 \pm 1.68$ | $38.02 \pm 3.33$ | $26.20 \pm 2.19$ (Single Bond 2), $34.47 \pm 3.34$ (Single Bond Universal), $33.27 \pm 3.91$ (Tetric - N - Bond Universal) |
| Degree of Conversion (GC) | Mean $\ge$ competing adhesives | $53.8 \pm 0.5$ | $55.80 \pm 0.5$ | $43.5 \pm 1.3$ (Single Bond 2), $55.60 \pm 0.5$ (Single Bond Universal), $45.07 \pm 0.6$ (Tetric - N - Bond Universal) |
| Shear Bond Strength (MPa) (ISO 29022:2013) | Mean $\ge$ competing adhesives (ISO 29022 does not quantify acceptable values, so comparison to recognized brands is used) | $22.21 \pm 2.33$ | $16.30 \pm 1.67$ | $20.06 \pm 2.52$ (Single Bond 2), $16.97 \pm 1.83$ (Single Bond Universal), $11.91 \pm 1.39$ (Tetric - N - Bond Universal) |
| pH | Low hydrogen potential as competing adhesives (comparative analysis) | $3.16 \pm 0.02$ | $2.97 \pm 0.04$ | $4.69 \pm 0.03$ (Single Bond 2), $3.28 \pm 0.19$ (Single Bond Universal) |
| Viscosity (mPa.s) | In accordance with desired application (based on market absence of claims) | $81.33 \pm 2.05$ | $99.20 \pm 0.40$ | Not performed for predicate devices (not contemplated in regulations) |
| Water Sorption ($\mu g/mm^3$) | Better or statistically equal to competitors | $140.80 \pm 1.60$ | $145.53 \pm 3.12$ | $150.76 \pm 2.26$ (Single Bond 2), $148.38 \pm 2.28$ (Single Bond Universal) |
| Water Solubility ($\mu g/mm^3$) | Better or statistically equal to competitors | $64.61 \pm 1.86$ | $64.71 \pm 1.59$ | $63.29 \pm 2.59$ (Single Bond 2), $71.24 \pm 5.54$ (Single Bond Universal) |
| Accelerated Stability Studies | Product maintains characteristics for estimated shelf life | Ambar APS: Shelf life estimated at 3 years ($30^\circ C$) | Ambar Universal APS: Shelf life estimated at 2 years ($25^\circ C$) | Not applicable (Individual product stability) |
| Long-Term Stability Evaluation | Confirms expiration date and storage conditions | Ambar APS: 3 years at $30^\circ C$ confirmed | Ambar Universal APS: 2 years at $30^\circ C$ confirmed | Not applicable (Individual product stability) |
| Transport Evaluation | Product maintains characteristics during transport | Product can be transported between $50^\circ C$ and $-5^\circ C$ | Product can be transported between $50^\circ C$ and $-5^\circ C$ | Not applicable (Individual product transport) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes (e.g., number of specimens tested) for each physical/chemical test. It presents mean values with standard deviations, which implies multiple measurements were taken for each test. The data provenance is not specified beyond being "non-clinical testing" and conducted for a Brazilian manufacturer (DentsCare LTDA). It is implicitly a prospective evaluation of newly manufactured devices under controlled laboratory conditions, not retrospective or prospective patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable. The "ground truth" for this type of non-clinical testing is established by physical and chemical measurements (e.g., MPa for strength, pH values) performed in a laboratory setting, not by human expert interpretation of images or clinical outcomes.
4. Adjudication Method for the Test Set
This section is not applicable, as the data collection involves objective physical/chemical measurements, not subjective evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This document describes non-clinical laboratory testing of dental bonding agents, not an AI-assisted diagnostic device evaluated with human readers.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Yes, in a sense, the performance described here is "standalone" to the device itself (the bonding agent) and its inherent physical/chemical properties, rather than its interaction with a human user or an AI algorithm. The performance metrics are intrinsic to the material.
7. The Type of Ground Truth Used
The ground truth used for these tests is objective, quantitative physical and chemical measurements obtained through laboratory testing, such as:
- Adhesive Strength: Measured in Megapascals (MPa).
- Conversion Rate: Percentage of monomer converted to polymer.
- Shear Bond Strength: Measured in Megapascals (MPa).
- pH: pH value.
- Viscosity: Measured in milliPascal-seconds (mPa.s).
- Water Sorption/Solubility: Measured in micrograms per cubic millimeter ($\mu g/mm^3$).
- Stability: Duration under specific temperature conditions.
8. The Sample Size for the Training Set
This section is not applicable. This is not an AI/machine learning study, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable, as there is no training set for this type of non-clinical device testing.
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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.
December 13, 2019
DentsCare LTDA % Rodrigo Abreu Regulatory Specialist United Regulatory LLC 12343 NW 25th St Coral Springs, Florida 33065
Re: K183424
Trade/Device Name: Ambar, Ambar APS, Ambar Universal APS Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: November 11, 2019 Received: November 13, 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
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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,
for Srinivas 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
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Indications for Use
510(k) Number (if known) K183424
Device Name Ambar APS and Ambar Universal APS
Indications for Use (Describe)
-
All classes of direct restoration with composites (class I, II, III, IV and V);
-
Adhesive luting (in addition to resin cement) of prosthetic pieces (post/cores, crowns, onlays/inlays, veneers etc.) made of fiberglass, ceromer, ceramic, resin and metal;
-
Adhesive repairs in ceramic and composites.
*Only for Ambar Universal APS: Use as metallic or ceramic primer.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/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).
Section 5 510(k) SUMMARY
Revision date: December 12, 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: December 12, 2019
- F) Classification Name: Resin tooth bonding agent
Common / Usual Name: Tooth Bonding Adhesive
Proprietary Name: Ambar APS and Ambar Universal APS
Product Code: KLE
Class: Class II
Regulation: 21 CFR 872.3200
G) Device Description
Ambar APS
Ambar APS is a light-curing 5th generation adhesive (two-step adhesive, total etch technique) for bonding restorative materials to dental tissue (enamel and/ or dentin). As the primer and the bonding agent are combined in a single bottle, acid etching is the only previous step needed before applying the adhesive to dentin and enamel.
Ambar Universal APS
Ambar Universal APS is a single flask self-etch light-curing adhesive system (Seventh Generation) responsible for the union between tooth structure (enamel and dentin) and restorative materials. The primer and bonding agent are combined in a single flask. Prior use of acid etchant is optional on both tooth 's enamel and dentin, it can be used, therefore, in three ways: self-etch, selective-etch and total-etch.
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Image /page/4/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 contact information includes the company's address: AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL, and phone number: Ph: 55 - 47 - 3441-6131.
H) Substantial Equivalence:
The Ambar APS and Ambar Universal APS are equivalent with the following products:
| 510(k) Number | Model | Company |
|---|---|---|
| K962785(primary predicate) | 3M Dent System (Single Bond 2) | 3M COMPANY |
I) Reference Devices:
| 510(k) Number | Model | Company | Indication for Use Comparison | |||
|---|---|---|---|---|---|---|
| K110302 | Adhesive EXL 759 (Single Bond Universal) | 3M COMPANY | Ambar APS andAmbar UniversalAPS | 3M Dent System(Single Bond 2) | Adhesive EXL 759(Single BondUniversal) | Adhese Universal(Tetric - N – BondUniversal) |
| K133318 | Adhese Universal (Tetric – N – BondUniversal) | Ivoclar | Dentscare | 3M(primary predicate) | 3M | Ivoclar |
| - All classes ofdirect restorationwith composites(class I, II, III, IVand V); | Direct light-curedcomposite/compomerrestorations | All classes of fillings(according to Black)with light-curingcomposite orcompomer fillingmaterials | Direct-placed light-curing composite andcompomer restorations | |||
| - Adhesive luting(in addition to resincement) ofprosthetic pieces(post/cores,crowns,onlays/inlays,veneers etc.) madeof fiberglass,ceromer, ceramic,resin and metal;- Adhesive repairsin ceramic andcomposites.*Only for AmbarUniversal APS: Useas metallic orceramic primer. | Porcelain veneers(when used withRelyX™ VeneerCement)Crown & bridge,inlay/onlay, bondingamalgam (when usedwith RelyX™ ARCAdhesive ResinCement) | Cementation of indirectrestorations (inlays,onlays, crowns,bridges, veneers) ofcomposite, compomer,ceramic, and metalwhen combined withSuglue-10 AdhesiveResin Cement,manufactured by 3M ESPECementation of veneerswhen combined withRelyX Veneer Cement,manufactured by 3M ESPEBonding of core build-upsmade of light-curingcomposite or core build-upmaterialsBonding of dual-curecements and core build-upmaterials and self-curecomposites when combinedwith Activator EXL 760 | Direct-placed corebuild-ups with light-, self- and dual-curing compositesAdhesive cementation of indirect restorations with light- and dual- curing luting composites | |||
| Porcelain / compositerepair | Repair of composite orcompomer fillingsIntraoral repair ofcomposite restorations,porcelain fused tometal, and all-ceramicrestorations withoutextra primer | Repair of fracturedcomposite andcompomer restorations. |
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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 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).
J) Indications for Use:
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Image /page/6/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a gray color. Inside the "D" are three horizontal lines that resemble sound waves. Below the "D" is the text "DentsCare" in a sans-serif font, also in gray.
. EDGAR NELSON MEISTER, 474, JOINVILLE, ARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
| Not indicated | Surface treatment ofporcelain, ceramics(including glassceramics, zirconia andalumina), metal andcomposite | Not indicated |
|---|---|---|
| Root surfacedesensitization | Root surfacedesensitization | Desensitization ofhypersensitive cervicalareas |
| Not indicated | Sealing of cavities priorto cementation ofamalgamaterestorationsSealing of cavities andpreparation of toothstumps prior totemporary cementationof indirect restorations | Sealing of preparedtooth surfaces beforetemporary / permanentcementation of indirectrestorations |
| Not indicated | Bonding of fissuresealantsProtective varnish forglass ionomer fillings | Not indicated |
Discussion: The subject devices are adhesive systems that offer the dental professional a wide range of applications. The Ambar APS and Ambar Universal APS are substantially equivalent to the predicate device (Single Bond 2) and the reference devices (Single Bond Universal and Tetric – N – Bond Universal) above in that all are intended to be used as a 21 CFR 872.3200 resin tooth bonding agent. The subject devices are substantially equivalent to Single Bond 2 in terms of indications. Regarding the claim "Use as metallic or ceramic primer", the Ambar Universal APS it similar to the reference predicate, Single Bond Universal, that indicates the use for "Surface treatment of porcelain, ceramics (including glass ceramics, zirconia and alumina), metal and composite."
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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 three 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).
K) Technological Characteristics Comparison:
The predicate device used to establish substantial equivalence for the Ambar APS and Ambar Universal APS device is outlined below. This submission will provide a comparison of design, materials, and technical specifications of the Ambar APS and Ambar Universal APS to each of the predicate devices stratified by functional modality.
| DeviceManufacturerand CommonName | Ambar APSand AmbarUniversal APSDentscare | 3M DentSystem (SingleBond 2)3M(primary predicate) | Adhesive EXL759 (SingleBondUniversal)3M | AdheseUniversal(Tetric - N -BondUniversal)3M |
|---|---|---|---|---|
| 510k # | K183424 | K962785 | K110302 | K133318 |
| Classification | Class II | Class II | Class II | Class II |
| Regulation # | 21 CFR872.3200 | 21 CFR 872.3200 | 21 CFR872.3200 | 21 CFR872.3200 |
| Product Code | KLE | KLE | KLE | KLE, LBH |
| ClassificationName | Resin toothbonding agent | Resin toothbonding agent | Resin toothbonding agent | Resin toothbonding agent |
| PatientPopulation | No restriction,it can beapplied togeneralpopulation | No restriction, itcan be applied togeneralpopulation | No restriction,it can beapplied togeneralpopulation | No restriction,it can beapplied togeneralpopulation |
| PrescriptionUse | RX only | RX only | RX only | RX only |
| Environment | Dentalprosthetics andauthorizedlaboratoriesand clinics.Must be storedintemperaturesfrom 5° to30°C / 41° to86°F. | Dentalprosthetics andauthorizedlaboratories andclinics.It can be storedat roomtemperature. | Dentalprosthetics andauthorizedlaboratoriesand clinics.It can bestored at roomtemperature. | Dentalprostheticsandauthorizedlaboratoriesand clinics.Storeconditions notfound. |
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Image /page/8/Picture/4 description: The image shows the logo for DentsCare LTDA. The logo consists of a stylized letter D with three horizontal lines inside it, followed by the text "DentsCare". To the right of the logo is the text "DENTSCARE LTDA AV. EDGAR NELSON SANTA CATARINA 8 Ph: 55 - 47 - 3441-".
AV. EDGAR NELSON MEISTER, 474, JOINVILLE,
SANTA CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
| ApplicableStandards | ISO 29022; ISO10993. | ISO 29022; ISO10993. | ISO 29022; ISO10993. | ISO 29022; ISO10993. |
|---|---|---|---|---|
| Composition | MDP,methacrylatemonomers,photo initiators,co-initiators,stabilizers,Inert Load(Silicaparticles) andVehicle(ethanol).*Only in AmbarUniversal APS:water andsurfactant. | Dimethacrylateresins, HEMA,ethanol, water,photoinitiatorsystem and filler. | MDP,Dimethacrylateresins, HEMA,ethanol, water,photoinitiatorsystem, fillerand silane. | Methacrylates,Water,Ethanol,Highlydispersedsilicon dioxide,Initiators andStabilisers. |
| DeviceSterilization | Not Applicable | Not Applicable | Not Applicable | Not Applicable |
| Indication ofUse | - All classes ofdirectrestoration withcomposites(class I, II, III,IV and V);- Adhesiveluting (inaddition toresin cement)of prostheticpieces(post/cores,crowns,onlays/inlays,veneers etc.)made offiberglass,ceromer,ceramic, resinand metal; | 3M™ ESPE™Adper™ SingleBond 2 Adhesiveis indicated foruse in thefollowing typesof restorations.- Direct light-curedcomposite/compomerrestorations- Root surfacedesensitization-Porcelain /composite repair- Porcelainveneers (whenused withRelyX™ Veneer | - All classes offillings(according toBlack) withlight-curingcomposite orcompomerfilling materials- Cementationof indirectrestorations(inlays, onlays,crowns,bridges,veneers) ofcomposite,compomer,ceramic, andmetal whencombined withSuglue-10Adhesive ResinCement, | - Direct-placed light-curingcomposite andcompomerrestorations.- Direct-placed corebuild-ups withlight-, self-and dual-curingcomposites.- Repair offracturedcomposite andcompomerrestorations.- Adhesivecementationof indirectrestorations |
| ceramic andcomposites. | - Crown &bridge,inlay/onlay,bondingamalgam (whenused withRelyX™ ARCAdhesive ResinCement) | - Cementationof veneerswhen combinedwith RelyXVeneerCement,manufacturedby 3M ESPE- Bonding ofcore build-upsmade of light-curingcomposite orcore build-upmaterials- Bonding ofdual-curecements andcore build-upmaterials andself-curecompositeswhen combinedwith ActivatorEXL 760- Repair ofcomposite orcompomerfillings- Intraoralrepair ofcompositerestorations,porcelain fusedto metal, andall-ceramicrestorationswithout extraprimer- Root surfacedesensitization- Sealing ofcavities prior tocementation ofamalgamaterestorations- Sealing ofcavities andpreparation oftooth stumpsprior totemporary | with light- anddual-curinglutingcomposites.- Sealing ofpreparedtooth surfacesbeforetemporary /permanentcementationof indirectrestorations.-Desensitization ofhypersensitivecervical areas. | |
| *Only forAmbarUniversal APS:Use as metallicor ceramicprimer. | ||||
| cementation ofindirectrestorations- Bonding offissure sealants- Protectivevarnish forglass ionomerfillings- Surfacetreatment ofporcelain,ceramics(including glassceramics,zirconia andalumina),metal andcomposite. | ||||
| How thedeviceachieves itsintendedpurpose | AdhesiveMaterial is alight-curing,single-componentdental adhesivefor direct andindirectbondingprocedures andetchingtechniques.With total etchadhesives themineral phaseof enamel anddentin issuperficiallydemineralizedby an acidicagent (ifnecessary) in aseparate stepprior toapplication ofthe adhesive.The acid usedis typically | AdhesiveMaterial is alight-curing,single-componentdental adhesivefor direct andindirect bondingprocedures andetchingtechniques.With total etchadhesives themineral phase ofenamel anddentin issuperficiallydemineralized byan acidic agent(if necessary) ina separate stepprior toapplication of theadhesive. Theacid used istypicallyphosphoric acid35-37%. | AdhesiveMaterial is alight-curing,single-componentdental adhesivefor direct andindirectbondingprocedures andetchingtechniques.With total etchadhesives themineral phaseof enamel anddentin issuperficiallydemineralizedby an acidicagent (ifnecessary) in aseparate stepprior toapplication ofthe adhesive.The acid usedis typically | AdhesiveMaterial is alight-curing,single-componentdentaladhesive fordirect andindirectbondingproceduresand etchingtechniques.With total etchadhesives themineral phaseof enamel anddentin issuperficiallydemineralizedby an acidicagent (ifnecessary) ina separatestep prior toapplication ofthe adhesive.The acid usedis typically |
| phosphoric acid35-37%. | phosphoric acid35-37%. | phosphoric acid35-37%. | phosphoric acid 35-37%. | |
| Side effects: | The adhesivecan causesensitizationreactions inpatients whoare sensitive toanycomponents ofthe formula. Inthis case, thematerial shouldnot be used. | The adhesive cancausesensitizationreactions inpatients who aresensitive to anycomponents ofthe formula. Inthis case, thematerial shouldnot be used. | The adhesivecan causesensitizationreactions inpatients whoare sensitive toanycomponents ofthe formula. Inthis case, thematerial shouldnot be used. | The adhesivecan causesensitizationreactions inpatients whoare sensitiveto anycomponents ofthe formula.In this case,the materialshould not beused. |
| PrimaryPackageContainer: | Vial | Unit dose or vial | Unit dose orvial | VivaPen® andVial |
| Shelf life | Up to 3 years | Up to 3 years | 2 years | Not found |
| Claims onproductperformanceand safety | Is a light-curingadhesive forbondingrestorativematerials todental tissue(enamel and/ordentin). | Is a light-curingadhesive forbondingrestorativematerials todental tissue(enamel and/ordentin). | Is a light-curing adhesivefor bondingrestorativematerials todental tissue(enamel and/ordentin). | Is a light-curingadhesive forbondingrestorativematerials todental tissue(enameland/ordentin). |
| Use the samematerials orsubstances incontact withthe samehumantissuesor bodyfluids? | YES | YES | YES | YES |
| Is theproduct incompliance toEN ISO10993? | YES | YES | YES | YES |
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Image /page/9/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 placed within the upper part of the "D", suggesting movement or flow. Below the "D", the word "DentsCare" is written in a simple, sans-serif font, also in the same muted blue-gray color.
DENTSCARE LTDA
AV. EDGAR NELSON MEISTER, 474, JOINVILLE,
SANTA CATARINA 89219-501 BRAZIL DentsCare ph: 55 - 47 - 3441-6131
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Image /page/10/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a gray color. Three horizontal lines are placed inside the "D" to the left. The text "DentsCare" is written below the "D" in a sans-serif font.
DENTSCARE LTDA AV. EDGAR NELSON MEISTER, 474, JOINVILLE,
SANTA CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
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Image /page/11/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter 'D' in gray, with three horizontal lines emanating from the left side of the 'D', resembling sound waves or air currents. Below the 'D' is the text 'DentsCare' in a sans-serif font, also in gray. The overall design is clean and modern.
DENTSCARE LTDA
AV. EDGAR NELSON MEISTER, 474, JOINVILLE,
SANTA CATARINA 89219-501 BRAZIL DentsCare Ph: 55 - 47 - 3441-6131
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Image /page/12/Picture/0 description: The image contains 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, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL, and their phone number: 55-47-3441-6131.
| Tissues | Enamel andDentin | Enamel andDentin | Enamel andDentin | Enamel andDentin |
|---|---|---|---|---|
| Reusable | NO | NO | NO | NO |
| Duration | Permanent | Permanent | Permanent | Permanent |
| Part of body | Oral, tooth | Oral, tooth | Oral, tooth | Oral, tooth |
| Is it used forthe sameclinicalcondition? | YES | YES | YES | YES |
| Is it used atthe same sitein the body? | YES | YES | YES | YES |
| Is it used in asimilarpopulation? | YES | YES | YES | YES |
| Is it used forthe sameintendedpurpose? | YES | YES | YES | YES |
| Is notforeseen todeliversignificantlydifferentperformances? | NO | NO | NO | NO |
| Is it similarconditions ofuse? | YES | YES | YES | YES |
| Is it similarspecificationsandproperties | YES | YES | YES | YES |
| Is it similarprinciples ofoperation? | YES | YES | YES | YES |
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Image /page/13/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" with horizontal lines inside it, above the word "DentsCare" in a stylized font. To the right of the logo is the text "DENTSCARE AV. E SANTA Ph: 5".
DENTSCARE LTDA AV. EDGAR NELSON MEISTER, 474, JOINVILLE, A CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
| AdhesiveStrength(MPa) | Ambar APS38,61 ± 1,68AmbarUniversal APS38,02 ± 3,33 | 26,20 ± 2,19 | 34,47 ± 3,34 | 33,27 ± 3,91 |
|---|---|---|---|---|
| Conversionrate | Ambar APS53,8 ± 0,5AmbarUniversal APS55,80 ± 0,5 | 43,5 ± 1,3 | 55,60 ± 0,5 | 45,07 ± 0,6 |
| Shear bondstrength(MPa) | Ambar APS22,21 ± 2,33AmbarUniversal APS16,30 ± 1,67 | 20,06 ± 2,52 | 16,97 ± 1,83 | 11,91 ± 1,39 |
| pH | Ambar APS3,16 ± 0,02AmbarUniversal APS2,97 ± 0,04 | 4,69 ± 0,03 | 3,28 ± 0,19 | Not performed |
| Viscosity(mPa.s) | Ambar APS81,33 ± 2,05AmbarUniversal APS99,20 ± 0,40 | Not performed | Not performed | Not performed |
| Watersorption(µg/mm³) | Ambar APS140,80 ± 1,60AmbarUniversal APS145,53 ± 3,12 | 150,76 ± 2,26 | 148,38 ± 2,28 | Not performed |
| Watersolubility(µg/mm³) | Ambar APS64,61 ± 1,86AmbarUniversal APS64,71 ± 1,59 | 63,29 ± 2,59 | 71,24 ± 5,54 | Not performed |
Discussion:
The subject device is similar to the predicate devices in that they are all dental adhesives for promoting union between tooth structure (enamel and dentin) and restorative materials.
Despite differences in results, the subject device demonstrates substantial equivalence to the declared predicates, since all products meet ISO 29022 and the results match
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Image /page/14/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. 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).
the requirements of this International Standard and it does not affect the substantial equivalence.
- Adhesive Strength: The average of the results of the adhesive under analysis is ≥ the average of the internationally renowned brand analyzed in this study.
The bond tensile strength exhibits slightly higher values than shear bond strength. Although there is no minimum tensile bond strength value, 20 MPa or more has been proposed as a reasonable value and a goal to be achieved.
By the results obtained, all the adhesives analyzed presented satisfactory results, with slightly higher values obtained by Dentscare adhesives.
The performance of Ambar APS and Ambar Universal APS satisfactorily met the requirements to support substantial equivalence to the predicate.
- Conversion rate: The average of the results of the adhesive under analysis is > the average of the internationally renowned brand analyzed in this study.
The dental compounds basically consist of a mixture of monomers, filler particles, photoinitiator system, inhibitors and dyes. The monomers have methacrylic groups with the carbon double bond, which are photoactivated, form along several polymer chains. The amount of monomers which are converted into polymers represent the major part of the final product, having a lower volume and a smaller amount of free monomers which can be leachable. An analysis of the volume of data is done by analyzing the amount of duplications that have been disrupted, indicating an expression of polymer chains. The higher the conversation rate values, better the results and efficacy of the final product.
By the results obtained, Ambar APS and Ambar Universal APS have presented the highest values, obtaining a higher efficiency of the final product when compared to the predicate. Thus, the results support substantial equivalence to the predicate.
- Shear bond strength: The average of the results of the adhesive under analysis is ≥ the average of the internationally renowned brands analyzed in this study.
The evaluation of the bonding efficiency between an adhesive and the dentin region is usually analyzed by bond strength between bonded specimens in shear or traction until fracture occurs. There is a wide variability of values (deviation) related to several factors such as water content in the dentin, cleaning of the "Smear Layer", orientation of the dentinal tubules.
The enamel structure has a high content of inorganic material (mineral hydroxyapatite) and low amount of organic material such as collagen, thus presenting a lower water content and facilitating adhesive bonding. However in dentine the amount of organic material is higher and, therefore, the humidity is also higher. As the restorative material is hydrophobic and the dentin is hydrophilic, the adhesive system has to be such that it can match both materials, thus, it must have an amphiphilic characteristic.
In summary, the higher the shear bond values, generally for bonding to the enamel, and bonding by traction, generally for adhesion to the dentin structure, the greater the effectiveness of the adhesive system.
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Image /page/15/Picture/0 description: The image contains the logo and contact information for DentsCare LTDA. The logo features a stylized letter D with wave-like lines inside. The contact information includes the address: AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL, and the phone number: Ph: 55 - 47 - 3441-6131.
The shear bond strength is one of the indicative of adhesive performance, indicating the shear strength between the tooth / adhesive / restorative interface. In enamel indicates the union effectiveness of an orthodontic cement, for example.
The higher the shear strength or tensile strength values, the greater the effectiveness of the product.
- pH: The pH test is not contemplated in standards for adhesives, however, it is known that 7th generation adhesives must have low hydrogen potential, thus performing the role of acid conditioning.
The average of the results for pH of the adhesive under analysis demonstrate that the subject devices have lower hydrogen potential than the average of the internationally renowned brands analyzed in this study.
-
Viscosity: The viscosity property is not contemplated in regulations for adhesives. This aspect does not have impact the in the performance of the product. For this reason, the predicate devices do not refer to viscosity of the product as a quality aspect.
-
Water sorption and Water solubility: The results show that the subject devices presented Sorption and Solubility similar to the competing adhesives under analysis. There is no specific standard for sorption and solubility testing on adhesives, so we follow the testing methodology established in ISO 4049 and as an approval criterion we define that the results of our adhesives should be better or statistically equal to competitors of recognized quality on market. ISO 4049 reference values have not been taken into account, assuming that the adhesive class is not covered by this standard.
Conclusion: From the results obtained, the subject devices, Ambar APS and Ambar Universal APS demonstrate equivalent indications for use, shelf life, physical, technical and mechanical properties.
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Image /page/16/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a dark gray color. Inside the "D", there are three horizontal lines that resemble waves. Below the symbol, the word "DentsCare" is written in a sans-serif font, also in dark gray.
R NELSON MEISTER, 474, JOINVILLE, ARINA 89219-501 BRAZIL 47 - 3441-6131
L) Applicable Standards:
In order to meet international requirements the device Ambar APS and Ambar Universal APS was developed, as well produced in compliance with recognized international requlations and standards for the medical device industry.
ISO 29022 - Dentistry - Adhesion - Notched edge shear bond strength test
ISO 10993-1 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (ENISO 10993-1:2009)
ISO 10993-3 - Biological Evaluation of Medical Devices - Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity.
ISO 10993-5 - Biological Evaluation of Medical Devices - Tests for In vitro Cytotoxicity. ISO 10993-10 - Biological Evaluation of Medical Device – Tests for Irritation and Skin Sensitization.
ISO 10993-11 - Biological Evaluation of Medical Devices - Tests for Systemic Toxicity.
Conclusion:
Based on compliance with the international standard and regulation mentioned above, the device Ambar APS and Ambar Universal APS demonstrate substantial equivalence to the predicates.
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Image /page/17/Picture/0 description: The image shows the logo for DentsCare. The logo consists of a stylized letter D with three horizontal lines inside it, followed by the text "DentsCare". To the right of the logo is the text "AV. EDGAR", "SANTA CAT", and "Ph: 55 - 47".
DENTSCARE LTDA AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL 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, for details about test results please see attachment 01.
| Test | Specification | Results |
|---|---|---|
| Adhesive StrengthTesting on DentalTissue. | A comparative analysis will be carried outbetween commercial adhesives ofinternationally recognized quality and theadhesive under analysis. It is defined thatthe acceptance criterion for this test, if theadhesive under study has a mean $\ge$ than thecompeting adhesives analyzed. | The average of the results of the adhesiveunder analysis is $\ge$ the average of theinternationally renowned brands analysed in thisstudy.Ambar APS: 38,61 ± 1,68 (MPa)Ambar Universal APS: 38,02 ± 3,33 (MPa)Single Bond 2 (3M - Espe): 26,20 ± 2,19 (MPa)Single Bond Universal: 34,47 ± 3,34 (MPa)Tetric - N - Bond Universal: 33,27 ± 3,91(MPa) |
| Test for determiningthe degree ofconversion (gc) | A comparative analysis will be carried outbetween commercial adhesives ofinternationally recognized quality and theadhesive under analysis. It is defined thatthe acceptance criterion for this test is if theadhesive under study has a mean $\ge$ thanthe competing adhesives analyzed. | The average of the results of the adhesiveunder analysis is $\ge$ the average of theinternationally renowned brands analysed in thisstudy.Ambar APS: 53,8 ± 0,5Ambar Universal APS: 55,80 ± 0,5Single Bond 2 (3M - Espe): 43,5 ± 1,3Single Bond Universal: 55,60 ± 0,5Tetric - N - Bond Universal: 45,07 ± 0,6 |
| Test of Shear bondstrength (ISO 29022:2013) | The ISO 29022: 2013 standard does notquantify acceptable and non-acceptablevalues, so a comparative analysis will becarried out between internationallyrecognized quality commercial adhesivesand the adhesive under analysis. It isdefined that the acceptance criterion for thistest, if the adhesive under study has a mean$\ge$ than the competing adhesives analyzed. | The average of the results of the adhesiveunder analysis is $\ge$ the average of theinternationally renowned brands analysed in thisstudy.Ambar APS: 22,21 ± 2,33 (MPa)Ambar Universal APS: 16,30 ± 1,67 (MPa)Single Bond 2 (3M - Espe): 20,06 ± 2,52 (MPa)Single Bond Universal: 16,97 ± 1,83 (MPa)Tetric - N - Bond Universal: 11,91 ± 1,39(MPa) |
| pH | A comparative analysis will be carried outbetween commercial adhesives ofinternationally recognized quality and theadhesive under analysis. It is defined thatthe acceptance criterion for this test, if theadhesive has low hydrogen potential ascompeting adhesives analyzed. | The average of the results for pH of theadhesive under analysis demonstrate that thesubject devices have lower hydrogen potentialthan the average of the internationallyrenowned brands analyzed in this study.Ambar APS: 3,16 ± 0,02Ambar Universal APS: 2,97 ± 0,04Single Bond 2 (3M - Espe): 4,69 ± 0,03Single Bond Universal (3M - Espe):3,28 ± 0,19 |
| Viscosity | Test conducted to attend the FDArequirement, it is no contemplated inregulations for adhesives. However, theyhave been on the market since 03/2017(Ambar APS) and 12/2017 (Ambar UniversalAPS) with no claims regarding viscosity orstickiness, therefore, we can state that itsviscosity is in accordance with the desiredapplication. | Ambar APS: 81,33 ± 2,05 mPa.sAmbar Universal APS: 99,20 ± 0,40 mPa.s |
| Water sorption | There is no specific standard for sorptionand solubility testing on adhesives, so wefollow the testing methodology establishedin ISO 4049 and as an approval criterion we | The results show that the subject devicespresented Sorption and Solubility similar to thecompeting adhesives under analysis.Ambar APS: 140,80 ± 1,60 µg/mm3 |
| define that the results of our adhesivesshould be better or statistically equal tocompetitors of recognized quality onmarket. | Ambar Universal APS: $145,53 ± 3,12$ µg/mm³Single Bond 2 (3M - Espe): $150,76 ± 2,26$ µg/mm³Single Bond Universal: $148,38 ± 2,28$ µg/mm³ | |
| Water solubility | There is no specific standard for sorptionand solubility testing on adhesives, so wefollow the testing methodology establishedin ISO 4049 and as an approval criterion wedefine that the results of our adhesivesshould be better or statistically equal tocompetitors of recognized quality onmarket. | The results show that the subject devicespresented Sorption and Solubility similar to thecompeting adhesives under analysis.Ambar APS: $64,61 ± 1,86$ µg/mm³Ambar Universal APS: $64,71 ± 1,59$ µg/mm³Single Bond 2 (3M - Espe): $63,29 ± 2,59$ µg/mm3Single Bond Universal: $71,24 ± 5,54$ µg/mm3 |
| Accelerated StabilityStudies | Study created to accelerate the possiblechemical degradation and/or physicalchanges of the product in forced conditionsof storage. | Ambar APS: Considering the results observedat the end of the 477 days of aging test, it isconcluded that the product can have its shelflife estimated at 3 years in the storagecondition of 30° C.Ambar Universal APS: Considering the resultsobserved at the end of the 225 days of agingtest, it is concluded that the product can haveits shelf life estimated at 2 years in the storagecondition of 25° C. |
| Evaluation Report ofLong-Term Stability(Shelf) | Study designed to verify the physical andchemical characteristics of the productduring the expected shelf life. The resultsare used to confirm the expiration date andstorage conditions. | Ambar APS: Considering the results observedat the end of the 36 months of the long-termtest (shelf), the shelf life of 3 years in thestorage condition of 30°C for the product canbe confirmed.Ambar Universal APS: Considering the resultsobserved at the end of the 24 months of thelong-term test (shelf), the shelf life of 2 yearsin the storage condition of 30°C for the productcan be confirmed. |
| Transport Evaluation | Study designed to verify the physical andchemical characteristics of the productduring transport. | According to Norm ND7000046 (determinationof expiry date and storage conditions ofproducts), the product can be transported attemperatures between 50°C and -5°C. |
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Image /page/18/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. Below the symbol is the text "DentsCare" in a sans-serif font, also in gray.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.