(162 days)
- Linings for single-surface and multiple-surface composite fillings
- Core build-up prior to crown placement
- Primary tooth fillings
- Stress bearing Class I restorations with at least one additional support outside of the filling area
- Stress bearing Class II restorations when the isthmus is less than half of the intercuspal distance and with at least one additional support outside of the filling area
- Cervical fillings, if aesthetics is not the prime consideration
- Single-surface and multiple-surface temporary fillings
- Fissure sealing
Ketac Universal Aplicap is a radiopaque glass ionomer restorative delivered in capsules used for bulk fillings. It can be applied without lining; releases fluoride ions and is available in various shades corresponding to the Vita™ Classical color system.
The provided text describes the 510(k) premarket notification for the "Ketac Universal Aplicap" dental cement and its substantial equivalence to a predicate device, "Equia." The text details various performance criteria, comparisons, and biocompatibility studies. However, it does not explicitly outline "acceptance criteria" as pass/fail thresholds against which the device performance is measured in a structured table or clinical study with patient outcomes. Instead, it compares the performance of Ketac Universal Aplicap to the predicate device and relevant ISO standards.
Based on the provided text, here's an attempt to extract and synthesize the requested information, acknowledging that some specific details (like direct acceptance criteria with pass/fail values, sample sizes for all tests, detailed expert qualifications, and specific multi-reader multi-case study results) are not fully present for an AI-based device, as this document pertains to a dental cement:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of "acceptance criteria" with defined pass/fail thresholds. Instead, it compares the performance of Ketac Universal Aplicap against the predicate device (Equia) and relevant ISO standards. The "Comparison" column implicitly acts as an assessment of whether the performance is considered acceptable or substantially equivalent.
| Performance Characteristic | Acceptance Criteria (Implicitly based on Predicate/ISO) | Reported Device Performance (Ketac Universal Aplicap) | Comparison to Predicate (Equia) & Notes |
|---|---|---|---|
| Consistency | Comparable to predicate (16 mm) | 14 mm | Comparable to Equia (16 mm). "No guidance or standard available to refer to." |
| Maximum solubility | Low level, meeting ISO 9917-1:2007 requirements | 0.11% | Equia (0.06%) is lower, but "both materials have a solubility on a low level that does not effect biocompatibility or mechanical properties. Moreover, Ketac Universal Aplicap meets the ISO 9917-1:2007 requirement with no acid soluble arsenic or lead content (0.00 mg/kg)." |
| Dimensional change, 24 hrs | Comparable to predicate (0.16%) | 0.24% | "Comparable to Equia at 24 hours". "The dimensional change as single property is not addressed by a standard or guidance." |
| Dimensional change, 72 hrs | Comparable to predicate (0.12%) | 0.18% | "Comparable to Equia at 72 hours." "Based on the accuracy of the test method it is concluded that the changes of lengths of Ketac Universal Aplicap are comparable to those of Equia." |
| Working time (in-house) | Suitable for dentist preference | 1:48 min:sec | Higher than Equia (1:12 min:sec). "Depends on the preference of the dentist. A longer working time provides the dentist with more time to handle the material." "Not addressed by a standard or guidance." |
| Setting time (in-house) | Suitable for dentist preference | 2:42 min:sec | Longer than Equia (2:12 min:sec). "The ideal working and setting times depend on the preferences of dentists." |
| Setting time (ISO 9917:2007) | Within 1.5 - 6.0 minutes | 2:30 min:sec | Equia (1:43 min:sec). Both "within the limit of 1.5 - 6.0 minutes." |
| Bonding strength, enamel | Comparable to predicate (5.0 MPa) | 5.7 MPa | "Comparable adhesion values on human enamel." |
| Bonding strength, dentin | Clinically sufficient | 5.1 MPa | Lower than Equia (10.0 MPa). "The review of clinical literature was presented in the 510(k), The literature showed that bonding strength of Ketac Universal Aplicap is sufficient for use. Therefore, this difference has no significant impact." |
| Fluoride release, 1 day | Not explicitly defined standard | 4.0 ppm | Lower than Equia (5.9 ppm). "Not addressed by a standard or guidance." |
| Fluoride release, 1 week | Not explicitly defined standard | 8.7 ppm | Lower than Equia (13.5 ppm). "Ketac Universal Aplicap and Equia release fluoride ions over a time period of at least 12 months." |
| Fluoride release, 2 weeks | Not explicitly defined standard | 11.4 ppm | Equia data not provided. |
| Fluoride release, 1 month | Not explicitly defined standard | 14.8 ppm | Lower than Equia (21.5 ppm). "The release of Equia is higher than Ketac Universal Aplicap during the first month. Afterwards the release rates are comparable." |
| Fluoride release (3,6,9,12 months) | Not explicitly defined standard | 22.4, 29.2, 35.1, 39.8 ppm | Generally lower than Equia (30.4, 38.6, 44.6, 49.4 ppm) during the first month, then "comparable" release rates. |
| Compressive Strength (ISO 9917-1) | Limit of 100 MPa for glass polyalkenoate cements | 188 MPa | Equia (200 MPa). Both "show comparable values according to the ISO method and both are above the limit of 100 MPa for glass polyalkenoate cements." |
| Compressive Strength (In-house) | Higher than predicate considered beneficial | 251.4 MPa | Higher than Equia (206.7 MPa). "Should be beneficial for the longevity." "According to the modified method of ISO 9917-1." |
| 3-Point Flexural Strength | Comparable to predicate (46.4 MPa) | 50.2 MPa | "Similar 3-point flexural strengths." "Not addressed by a standard or guidance for water based glass ionomer cements." "Nearly identical." |
| Surface Hardness 24 hours | Higher than predicate considered beneficial | 667.0 MPa | Higher than Equia (498.7 MPa). "Should be beneficial for the longevity." "Not addressed by a standard or guidance." |
| Biocompatibility | Safe for intended use per ISO and FDA guidance | Assessed as safe | Assessed by a board-certified toxicologist according to recommendations in FDA guidance and internationally recognized standards (ISO 10993 series, ISO 7405). The conclusion is that Ketac Universal Aplicap is safe for its intended use. |
2. Sample sizes used for the test set and the data provenance
The document does not explicitly state the sample sizes for the "test set" (i.e., for the in vitro physical and mechanical properties comparison). For biocompatibility, it states "assessed by a board-certified toxicologist" but doesn't mention sample sizes of biological tests.
Regarding data provenance, the studies are described as "in-house testing" for some parameters (working time, setting time, compressive strength), and comparisons are made against ISO standards. The submitter is "3M Deutschland GmbH" in Germany, implying the data generation origin. The studies are in vitro evaluations of material properties, not clinical trials with patient data, so "retrospective or prospective" does not directly apply in the usual clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is more pertinent to clinical studies or AI/diagnostic device evaluations where "expert ground truth" is established for patient cases. For this dental cement, the "ground truth" for material properties is established through standardized (e.g., ISO, P/L acid-base cements, Adhesives Notched Edge Sheer Bond Strength) or in-house mechanical and chemical testing methods.
For biocompatibility, the assessment was performed by "a board-certified toxicologist." The exact number (e.g., one or a team) is not specified.
4. Adjudication method for the test set
Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or expert reviews of ambiguous cases, particularly for AI diagnostic devices. This document describes material science testing and comparisons to predicate devices and standards, not a process that would involve human adjudication of results in that manner. The "comparison" is based on objective measurements and established chemical/physical principles.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. These studies are specific to diagnostic devices, particularly those involving human interpretation (readers) and AI assistance, to assess changes in diagnostic performance. This document is for a dental cement.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is a dental cement, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance comparisons comes from:
- Standardized Test Methods: Adherence to, or comparison against, ISO standards (e.g., ISO 9917-1 for dental cements).
- Predicate Device Performance: Direct measurement and comparison of properties against a legally marketed predicate device (Equia).
- Clinical Literature Review: For bonding strength to dentin, "a clinical literature review showed that a performance in the range of Ketac Universal Aplicap are clinically sufficient." This implies that existing clinical evidence for similar materials and their performance is considered a form of "ground truth" for clinical sufficiency.
- Toxicological Assessment: For biocompatibility, a board-certified toxicologist's assessment based on international standards forms the ground truth for safety.
8. The sample size for the training set
This is not applicable as the device is a dental cement, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a dental cement.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol of three stylized human profiles facing right. The profiles are stacked on top of each other, creating a sense of depth and unity. The seal is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 13, 2016
3M Deutschland GmbH Ruediger Franke ESPE Platz Seefeld, Bavaria 82229 GERMANY
Re: K153174
Trade/Device Name: Ketac Universal Aplicap Regulation Number: 21 CFR 872.3275 Regulation Name: Dental cement Regulatory Class: Class II Product Code: EMA Dated: March 14, 2016 Received: March 16, 2016
Dear Mr. Ruediger Franke:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Ketac Universal Aplicap
Indications for Use (Describe)
-
Linings for single-surface and multiple-surface composite fillings
-
Core build-up prior to crown placement
-
Primary tooth fillings
-
Stress bearing Class I restorations with at least one additional support outside of the filling area
-
Stress bearing Class II restorations when the isthmus is less than half of the intercuspal distance and with at least one additional support outside of the filling area
-
Cervical fillings, if aesthetics is not the prime consideration
-
Single-surface and multiple-surface temporary fillings
-
Fissure sealing
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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FORM FDA 3881 (8/14)
Page 1 of 1
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C. M
3M Deutschland GmbH
Carl-Schurz-Straße 1 41453 Neuss Germany
Postal Address: ESPE Platz 82229 Seefeld Germany
電+49 (0)8152 700-0 룡 +49 (0)8152 700-1366 Internet: www.3MESPE.de E-Mail: info3MESPE@3M.com WEEE-Reg.-Nr. DE 36963167 VAT-ID: DE 120679179
510(k) Summary
| 510(k) submitter: | 3M Deutschland GmbHESPE Platz82229 SeefeldGermanyEstablishment Registration Number: 961138 |
|---|---|
| Contact Person | Ruediger FrankeRegulatory Affairs SpecialistPhone: +49-8152-700 1802Fax: +49-8152-700 1869e-mail: ruediger.franke@3M.com |
| Date: | March 14, 2016 |
| Trade Name: | Ketac Universal Aplicap |
| Common Name: | Glass ionomer restorative material |
| Classification Name: | Dental cement(21 CFR 872.3275, product code EMA) |
| Device Class: | Class II |
| Predicate Devices | Equia (K091106) |
Description of Device
Ketac Universal Aplicap is a radiopaque glass ionomer restorative delivered in capsules used for bulk fillings. It can be applied without lining; releases fluoride ions and is available in various shades corresponding to the Vita™ Classical color system.
Applicable Standards for Product Tests
- ISO 9917-1: Dentistry-- Water-based cements Part 1: Powder/liquid acid-base . cements
- 1SO 29022: Dentistry Adhesive Notched Edge Sheer Bond Strength Test .
Image /page/3/Picture/13 description: The image shows a logo with three concentric circles and the text "Deutsche" and "Center". To the right of the logo, the text "Page 4 of 28" is visible. The logo appears to be a certification mark or symbol, possibly related to German standards or quality assurance.
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Indications for Use for Ketac Universal Aplicap
- Linings for single- and multiple-surface composite fillings
- · Core build-up prior to crown placement
- · Primary tooth fillings
- Stress bearing Class I restorations with at least one additional support outside of the filling area
- · Stress bearing Class II restorations when the isthmus is less than half of the intercuspal distance and with at least one additional support outside of the filling area
- · Cervical fillings, if aesthetics is not the prime consideration
- · Single- and multiple-surface temporary fillings
- Fissure sealing .
Comparison
| Ketac Universal Aplicap | Equia(Predicate Device,(K091106, by GC) | Comparison |
|---|---|---|
| Stress bearing Class Irestorations with at leastone additional supportoutside of the filling area | Class I restorations | More restrictive and conservativeClass I indication for Ketac UniversalAplicap despite comparablemechanical properties |
| - | Non-stress bearingClass II restorations | Despite comparable mechanicalproperties this indication is notclaimed by 3M Deutschland GmbH |
| Stress bearing Class IIrestorations when theisthmus is less than half ofthe intercuspal distance andwith at least one additionalsupport outside of the fillingarea | Stress bearing ClassII restorations whenthe isthmus is lessthan half ofintercuspal distance | More restrictive and conservativeClass II indication for KetacUniversal Aplicap despitecomparable mechanical properties |
| Single- and multiple-surfacetemporary fillings | Intermediaterestorative | Same indication but differentwording. |
| Cervical fillings, if aestheticsis not the primeconsideration | Class V and rootsurface restorations | Same indication but differentwording. |
| Core build up prior to crownplacement | Core build-up | Same indication but differentwording. |
| Linings for single- andmultiple-surface compositefillings | - | Indication is not separately claimedby GC. The indication linings can beviewed as a small Class I/Class IIrestorations with reducedmechanical performancerequirements. |
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| Ketac Universal Aplicap | Equia(Predicate Device,(K091106, by GC) | Comparison |
|---|---|---|
| Primary tooth fillings | - | Indication is not separately claimedby GC. The indication for use inprimary tooth fillings emphasizesthat the material is suitable for usefor use in children. |
| Fissure sealing | - | Indication is not separately claimedby GC. The indication fissure sealingis comparable with a small Class Iindication. |
Table Comparison of indications
Despite comparable mechanical properties between the two products 3M Deutschland GmbH uses a more restrictive and conservative range for Ketac Universal Aplicap for stress bearing Class I and Class II indications in comparison to GC America for Equia. The restriction to recommend additional support from outside the filling area will give additional support to the filling and therefore reduce the stress.
The indications for use in temporary filling, Class V restorations and core build-ups are equivalent for Ketac Universal Aplicap and the predicate device but with a slightly different wording.
Additional comments to Indication subset not claimed by GC
- Linings for single- and multiple-surface composite fillings .
- . Fissure sealing
- . Primary tooth fillings
All three indications are subsets of the listed indications in table Comparison of indications. Linings for single-surface and multiple-surface composite fillings are only a thin layer under a protective composite filling material. Therefore, linings can be considered as small Class I/ Class II restorations with reduced mechanical performance requirements.
The indication for use in fissure sealing is comparable with a small Class I indication. The indication for use in primary tooth fillings emphasizes that the material is suitable for use in children.
These subset indications claimed for Ketac Universal Aplicap are not claimed by GC but don't influence the safety and efficacy of the device Ketac Universal Aplicap because the mechanical requirements for the material are fully covered by the other indications listed in the table Comparison of indications.
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In summary, it can be stated that all listed indications of Ketac Universal Aplicap are equivalent to the predicate device Equia with no new or increased indication.
| Ketac UniversalAplicap | Equia(Predicate Device,(K091106, by GC) | Comparison | |
|---|---|---|---|
| EssentialIngredients | Polyacrylic Acid,Oxide GlassChemicals, Water,and Tartaric Acid | Polyacrylic Acid,Oxide GlassChemicals, Water,and Tartaric Acid | equivalent |
| Powder/liquidcompoundsdelivered incapsules | X | X | equal |
| Glasspolyalkenoatecementaccording ISO9917-1: 2007 | X | X | equal |
| Use ofconditioner | No | X | It has been demonstrated that aconditioner does not increase thebonding strength of KetacUniversal Aplicap |
| Use of coat | Possible accordingIFU, but notmandatory | X | It has been demonstrated that acoat does not increase thesurface hardness of KetacUniversal Aplicap. |
| Properties | KetacUniversalAplicap | Equia(Predicate Device,(K091106, by GC) | Comparison |
| Consistency /mm | 14 | 16 | There is no guidance or standardavailable to refer to.The consistency of Ketac UniversalAplicap (14 mm) and Equia (16 mm)is comparable. |
| Maximum solubility /% | 0.11 | 0.06 | The solubility as single property is notaddressed by a standard or guidance.The solubility of Equia is lower thanthat of Ketac Universal Aplicap butboth materials have a solubility on alow level that does not effectbiocompatibility or mechanicalproperties. Moreover, Ketac UniversalAplicap meets the ISO 9917-1:2007requirement with no acid solublearsenic or lead content (0.00 mg/kg). |
| Dimensional change,24 hours /% | 0.24 | 0.16 | The dimensional change as singleproperty is not addressed by astandard or guidance. |
| Dimensional change,72 hours /% | 0.18 | 0.12 | The change of length of KetacUniversal Aplicap is low andcomparable to Equia at 24 hours andat 72 hours. Based on the accuracy ofthe test method it is concluded thatthe changes of lengths of KetacUniversal Aplicap are comparable tothose of Equia. |
| Working time /min:sec(in-house method) | 1:48 | 1:12 | The working time as single property isnot addressed by a standard orguidance.The working time according the in-house method of Ketac Universal ishigher than for Equia. It generallydepends on the preference of thedentist. A longer working timeprovides the dentist with more time tohandle the material. |
| Setting time /min:sec(in-house method) | 2:42 | 2:12 | The setting times for Ketac universalAplicap and Equia were evaluated |
| Setting time /min:sec(ISO 9917:2007) | 2:30 | 1:43 | according ISO 9917:2007. Both arewithin the limit of 1.5 - 6.0 minutes.The setting times according to the in-house method are for Ketac UniversalAplicap and Equia only slightlydifferent to the times stated in theinstruction for use. Ketac UniversalAplicap has longer setting time thanEquia. Also for this material propertythe ideal working and setting timesdepend on the preferences ofdentists. |
| Properties | KetacUniversalAplicap | Equia(Predicate Device,(K091106, by GC) | Comparison |
| Bonding strength,enamel /MPa | 5.7 | 5.0 | Equia and Ketac Universal Aplicaphave comparable adhesion values onhuman enamel. |
| Bonding strength,dentin /MPa | 5.1 | 10.0 | The adhesion of Equia on dentin ishigher compared to Ketac UniversalAplicap. The review of clinicalliterature was presented in the 510(k),The literature showed that bondingstrength of Ketac Universal Aplicap issufficient for use. Therefore, thisdifference has no significant impact. |
| Fluoride release, 1day /ppm | 4.0 | 5.9 | The fluoride release rate as singleproperty is not addressed by astandard or guidance. |
| Fluoride release, 1week /ppm | 8.7 | 13.5 | Ketac Universal Aplicap and Equiarelease fluoride ions over a timeperiod of at least 12 months. The |
| Fluoride release, 2weeks /ppm | 11.4 | - | |
| Fluoride release, 1month /ppm | 14.8 | 21.5 | release of Equia is higher than KetacUniversal Aplicap during the firstmonth. Afterwards the release ratesare comparable. |
| Fluoride release, 3months /ppm | 22.4 | 30.4 | |
| Fluoride release, 6months /ppm | 29.2 | 38.6 | |
| Fluoride release, 9months /ppm | 35.1 | 44.6 | |
| Fluoride release, 12months /ppm | 39.8 | 49.4 | |
| Compressive Strength(ISO 9917-1) /MPa | 188 | 200 | Ketac Universal Aplicap and Equiashow comparable values according tothe ISO method and both are abovethe limit of 100 MPa for glasspolyalkenoate cements. |
| Compressive Strength(In-house method)/MPa | 251.4 | 206.7 | Ketac Universal Aplicap shows ahigher compressive strength thanEquia according the modified methodof ISO 9917-1 which should bebeneficial for the longevity. |
| 3-Point FlexuralStrength /MPa | 50.2 | 46.4 | The flexural strength as singleproperty is not addressed by astandard or guidance for water basedglass ionomer cements.Ketac Universal Aplicap and Equiahave similar 3-point flexural strengths. |
| Surface Hardness 24hours /MPa | 667.0 | 498.7 | The surface hardness as singleproperty is not addressed by astandard or guidance.Ketac Universal Aplicap shows ahigher surface hardness than Equiawhich should be beneficial for thelongevity. |
Table Comparison of essential ingredients and technology
Ketac Universal Aplicap and Equia are glass polyalkenoate cements compliant with ISO 9917-1: 2007 delivered in capsules. The essential ingredients of both products are polyacrylic acid, oxide glass chemicals, water, and tartaric acid. The main difference in the application of Ketac Universal Aplicap to the predicate device Equia is that for Ketac Universal Aplicap neither a coat nor the use of conditioner is required. It has been shown that the use of a coat does not increase the surface hardness of Ketac Universal Aplicap. Further it has been demonstrated that a conditioner does not increase the bonding strength. In Summary, both products are glass polyalkenoate cements with similar composition and technology. Additional coating or conditioning steps did not lead to superior properties (surface hardness, adhesion) for Ketac Universal Aplicap.
In vitro testing was conducted to examine consistency, maximum solubility, dimensional change, working and setting time, bonding strength, fluoride release, compressive strength, 3-point flexural strength, and surface hardness comparing the performance of Ketac Universal Aplicap to Equia.
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Table Comparison of physical and mechanical properties
:
:
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In case of dimensional change, 3-point flexural strength and bonding strength to enamel the values for both devices are nearly identical. The adhesion of Equia on dentin is higher compared to Ketac Universal Aplicap. However, a clinical literature review showed that a performance in the range of Ketac Universal Aplicap are clinically sufficient. With respect to fluoride release Equia shows a higher rate in the first month and a comparable rate to Ketac Universal Aplicap thereafter. With respect to consistency, working time and setting time these properties show slightly differences depending on the preferences of the dentist. Both materials have a solubility on a low level that does not effect biocompatibility. The compressive strength (according in-house method) and the surface hardness of Ketac Universal Aplicap exhibited higher values than the predicate device Equia which should lead to higher longevity of the restoration.
Biocompatibility
The biocompatibility assessment for this product was conducted in accordance with the following quidance:
-
Testing guidelines outlined in the FDA General Program Memorandum G95. 2) ISO 10993-1:2009(E) Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process; in addition, relevant detailed guidance in ISO Standards 10993-3:2014 (Tests for genotoxicity, carcinogenicity and reproductive toxicity), 10993-5:2009 (Tests for in vitro cytotoxicity), 10993-10:2010 (Tests for irritation and skin sensitization); and 10993-11:2006 (Tests for systemic toxicity) was considered; 3) ISO 7405:2008 / Amd 1:2013 Dentistry-- Evaluation of Biocompatibility of Medical Devices in Dentistry; and
-
Japan: PFSB/ELD/OMDE Notification No. 0301-1 Mar. 1, 2012; (as translated by 3M Health Care Japan, August 6, 2012).
The biocompatibility of Ketac Universal Aplicap has been assessed by a board-certified toxicologist according to recommendations in FDA guidance and internationally recognized standards for medical and dental devices. The conclusion of the assessment is that Ketac Universal Aplicap is safe for its intended use.
Conclusion
Comparisons of indications for use, essential ingredients, technology, and physical and mechanical properties showed that Ketac Universal Aplicap is substantially equivalent to the predicate device.
§ 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.