(123 days)
- Non-load bearing Class I and II restorations
- Deciduous teeth restorations
- Geriatric restorations
- Intermediate restorative and base material for Class I and II cavities using the sandwich technique
- Cervical (Class V) restorations
- Core build ups
- Temporary fillings
- Dentin replacement
Ceramir Restore QuikCap is a self-curing bioceramic restorative material of glass ionomer type. It is a hybrid between a glass ionomer cement and a ceramic cement based on calcium aluminate. The material is radiopaque.
Ceramir Restore QuikCap contains a ceramic powder and a liquid, separated in different compartments, in a plastic capsule.
The capsule is activated just before use, allowing the powder and liquid to blend in the capsule. The content is mixed by using a high-frequency oscillating or rotating capsule mixer.
A capsule applicator, "Ceramir Applicator 2", is needed to extrude the mixed material into the tooth cavity.
The applied cement is formed using conventional tooth filling techniques. After setting, the material is ready for finishing and dry polishing.
The cement is available in shade A2 and is designated opaque (Vita shade guide).
The provided document is an FDA 510(k) Premarket Notification for a dental cement called Ceramir® Restore QuikCap. It details the device's characteristics, intended use, indications for use, and a comparison to a predicate device (Riva Self Cure) to demonstrate substantial equivalence.
However, the document does not describe acceptance criteria or a study that proves a device meets acceptance criteria in the context of an AI/ML-based medical device performance study.
Instead, this document describes the regulatory process for demonstrating substantial equivalence for a dental cement. The 'performance data' presented are physical and chemical properties of the cement, compared against a predicate device and relevant ISO standards, to show that the new device is as safe and effective as existing legally marketed devices.
Therefore, I cannot provide the requested information, particularly points related to AI/ML device studies such as:
- Acceptance criteria for an AI/ML device
- Sample size for test sets, data provenance, and ground truth establishment (other than the general "conforms to ISO 9917-1" or "FDA guidance document 'Dental Cements - Premarket Notification'")
- Number/qualifications of experts for ground truth establishment
- Adjudication methods
- MRMC comparative effectiveness study
- Standalone algorithm performance
- Training set details
The "study" referenced in the document is a series of non-clinical performance tests and biological evaluations to show the dental cement's properties align with established standards and are comparable to its predicate.
Here's what can be extracted from the document related to "acceptance criteria" in the context of this dental cement, rephrased to fit the actual content:
The acceptance criteria for this dental cement are implicitly defined by the relevant ISO standards (e.g., ISO 9917-1:2007) and FDA guidance documents for dental cements. The "performance data" table effectively serves as a comparison against these standards and the predicate device to demonstrate "substantial equivalence," which is the regulatory goal for a 510(k) submission.
1. Table of "Acceptance Criteria" (Implicit from Comparison) and Reported Device Performance:
| Parameter | Implicit "Acceptance Criteria" / Predicate Performance (Riva Self Cure) | Reported Device Performance (Ceramir Restore QuikCap) | Meets "Acceptance Criteria"? (Substantial Equivalence) |
|---|---|---|---|
| Intended Use | Self-curing conventional glass ionomer restorative material | Self-curing bioceramic restorative material | Yes (SE) |
| Indications for Use | Non-stress bearing Class I & II, Deciduous, Geriatric, Intermediate, Cervical (Class V), Core build-ups, Temporary, Dentin replacement, ART technique | Subset of predicate indications (without ART technique) | Yes (SE - difference does not affect safety/effectiveness) |
| Type of Mixing | Mixed in a capsule supplied by SDI LTD. | Mixed in a capsule supplied by SDI LTD. | Yes (SE) |
| Powder to liquid ratio | 3.2 g/g | 3.0 g/g | Yes (SE) |
| Chemical composition | Glass ionomer | Glass ionomer/calcium aluminate | Yes (SE - evaluated by performance/biological testing) |
| Compressive strength at 24 hours | 171 MPa (Conforms to ISO 9917-1) | 189 MPa (Conforms to ISO 9917-1) | Yes (SE) |
| Radiopacity | Radiopaque (2.5 mm Al) (Conforms to ISO 9917-1) | Radiopaque (2.0 mm Al) (Conforms to ISO 9917-1) | Yes (SE) |
| Maximum solubility and disintegration (Acid erosion) | Conforms to ISO 9917-1** (Specific value not provided for predicate) | 0.04 mm (Conforms to ISO 9917-1) | Yes (SE) |
| Dimensional change | <1% | <1% | Yes (SE) |
| Acid soluble lead content | Conforms to ISO 9917-1** (Specific value not provided for predicate) | 0.14 mg/kg (Conforms to ISO 9917-1) | Yes (SE) |
| Net setting time | 6 min (Conforms to ISO 9917-1) | 4-6 min (Conforms to ISO 9917-1) | Yes (SE) |
| Working time | 1:30 min (Conforms to ISO 9917-1) | >1 min (Conforms to ISO 9917-1) | Yes (SE) |
| Shear bond strength against dentin | Max: 8.7 MPa | Max: 17.0 MPa | Yes (SE - even though higher, implies at least equivalent or better) |
| Thermal conductivity (at 37°C) | 0.58 W/m K | 0.75 W/m K | Yes (SE) |
| Amount of heat generated during setting | 41.7°C | 40.2°C | Yes (SE) |
| Fluoride release | Continuous for at least 28 days | Continuous for at least 28 days | Yes (SE) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in terms of number of samples for each test, but the document refers to conformance with ISO standards (e.g., ISO 9917-1), which would specify sample numbers for various tests.
- Data Provenance: The tests were conducted to evaluate a new dental cement for regulatory submission. The document doesn't specify country of origin for the testing data beyond the manufacturer being in Sweden. The tests are prospective in the sense that they were performed specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable to this type of device (dental cement) or study. "Ground truth" here refers to established material properties measured via standardized laboratory tests, not expert interpretation of medical images.
4. Adjudication method for the test set:
- Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
- Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable.
7. The type of ground truth used:
- Laboratory measurements according to established international standards (e.g., ISO 9917-1) and FDA guidance for dental cements. The "truth" is the measured physical and chemical properties of the material.
8. The sample size for the training set:
- Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable.
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Image /page/0/Picture/0 description: The image shows 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 13, 2020
Doxa Dental AB Anna-Lisa Tiensuu Regulatory Affairs Director Axel Johanssons Gata 4-6 Uppsala, 75450 SWEDEN
Re: K201937
Trade/Device Name: Ceramir® Restore QuikCap Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: August 13, 2020 Received: August 17, 2020
Dear Anna-Lisa Tiensuu:
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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201937
Device Name Ceramir® Restore QuikCap
Indications for Use (Describe)
- · Non-load bearing Class I and II restorations
- Deciduous teeth restorations
- Geriatric restorations
- · Intermediate restorative and base material for Class I and II cavities using the sandwich technique
- · Cervical (Class V) restorations
- · Core build ups
- · Temporary fillings
- Dentin replacement
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Doxa
510(k) Summary 5 K201937
5.1 Submitter information
| Submitted by: | Doxa Dental ABAxel Johanssons gata 4-6SE 754 50, Uppsala, SwedenPhone: +46 18 478 20 00 |
|---|---|
| Contact: | Anna-Lisa Tiensuu |
| Phone: | +46 70 394 42 99 |
| e-mail: | anna-lisa.tiensuu@doxa.se |
| Date Prepared: | November 12, 2020 |
Device Name 5.2
| Proprietary name | Ceramir® Restore QuikCap |
|---|---|
| Common name: | Bioceramic restorative material |
| Classification name: | Dental Cement |
| Device Classification: | Class II, 872.3275 |
| Product code: | EMA |
5.3 Predicate device
| Product | 510(k) No | Code | Predicate / Reference Device |
|---|---|---|---|
| Riva Self Cure | K030516 | EMA | Primary Predicate Device |
| Ceramir Crown & Bridge | K113040 | EMA | Reference Device |
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5.4 Intended Use
Ceramir® Restore QuikCap is a self-curing bioceramic restorative material of glass ionomer type.
5.5 Indications for Use
- Non-load bearing Class I and II restorations ●
- Deciduous teeth restorations ●
- Geriatric restorations ●
- Intermediate restorative and base material for Class I and II cavities using the ● sandwich technique
- . Cervical (Class V) restorations
- Core build ups
- Temporary fillings ●
- Dentin replacement
5.6 Device Description
Ceramir Restore QuikCap is a self-curing bioceramic restorative material of glass ionomer type. It is a hybrid between a glass ionomer cement and a ceramic cement based on calcium aluminate. The material is radiopaque.
Ceramir Restore QuikCap contains a ceramic powder and a liquid, separated in different compartments, in a plastic capsule.
The capsule is activated just before use, allowing the powder and liquid to blend in the capsule. The content is mixed by using a high-frequency oscillating or rotating capsule mixer.
A capsule applicator, "Ceramir Applicator 2", is needed to extrude the mixed material into the tooth cavity.
The applied cement is formed using conventional tooth filling techniques. After setting, the material is ready for finishing and dry polishing.
The cement is available in shade A2 and is designated opaque (Vita shade guide).
e-mail: info@doxa.se
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Doxa
| Parameter | Subject deviceCeramir Restore QuikCap | Primary Predicate deviceRiva Self Cure (K030516) | Comparison |
|---|---|---|---|
| Intended use | Ceramir Restore® QuikCap isa self-curing bioceramicrestorative material of glassionomer type | Riva Self Cure is a self-curingconventional glass ionomerrestorative material | SE |
| Indicationsfor use | • Non-load bearing Class Iand II restorations• Deciduous teeth restorations• Geriatric restorations• Intermediate restorative andbase material for Class I and IIcavities using the sandwichtechnique• Cervical (Class V)restorations• Core build ups• Temporary fillings• Dentine replacement | • Non stress bearing Class Iand II restorations• Deciduous teeth restorations• Geriatric restorations• Intermediate restorative andbase material for Class I and IIcavities using the sandwichtechnique• Cervical (Class V)restorations• Core build ups• Temporary fillings• Dentine replacement• Restorative in the fieldusing the ART technique | SESince theindications ofCeramir RestoreQuikCap is asubset of theclearedindications forRiva Self Cure,the differencewill not affectsafety andeffectiveness ofCeramir RestoreQuikCap. |
| Type ofMixing | Mixed in a capsule supplied bySDI LTD. | Mixed in a capsule supplied bySDI LTD. | SE |
| Powder toliquid ratio | $3.0 g/g$ | $3.2 g/g *$ | SE |
| Chemicalcomposition | Glass ionomer/calciumaluminate | Glass ionomer | SEThe differencesin chemicalcomposition donot raise anynew questionsof safety oreffectiveness asevaluated byperformancetesting andbiologicalevaluation. |
| Compressivestrength at 24hours | 189 MPaConforms to ISO 9917-1 | 171 MPaConforms to ISO 9917-1** | SE |
| Radio-opacity | Radiopaque (2.0 mm Al)Conforms to ISO 9917-1 | Radiopaque (2.5 mm Al)Conforms to ISO 9917-1** | SE |
| Maximumsolubility anddisintegration(Aciderosion) | 0.04 mmConforms to ISO 9917-1 | Not measured by DoxaConforms to ISO 9917-1** | SE |
| Dimensionalchange | <1% | <1% | SE |
| Acid solublelead content | 0.14 mg/kgConforms to ISO 9917-1 | Not measured by DoxaConforms to ISO 9917-1** | SE |
| Net settingtime | 4-6 minConforms to ISO 9917-1 | 6 min Conforms to ISO 9917-1* | SE |
| Working time | >1 minConforms to ISO 9917-1 | 1:30 min Conforms to ISO 9917-1* | SE |
| Shear bondstrengthagainst dentin | Max: 17.0 MPa | Max: 8.7 MPa | SE |
| Thermalconductivity(at 37°C) | 0.75 W/m K | 0.58 W/m K | SE |
| Amount ofheatgeneratedduring setting | 40.2°C | 41.7°C | SE |
| Fluoriderelease | Continuous for at least 28 days | Continuous for at least 28 days | SE |
5.7 Technological characteristics and performance data
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*Data from Riva Self Cure Instructions for Use
** Conformance with ISO 9917-1 is stated in the Riva Self Cure labelling
Non-clinical performance data 5.8
Differences in technological characteristics have been evaluated with performance testing and biological evaluation to show that Ceramir Restore QuikCap is as safe and effective as its predicate device.
Ceramir Restore QuikCap has been tested in accordance with the FDA guidance document "Dental Cements - Premarket Notification" and the FDA recognized performance standard ISO 9917-1:2007. Ceramir Restore QuikCap fulfills the applicable requirements and is similar in performance to the predicate device Riva Self Cure.
The biological evaluation of Ceramir Restore QuikCap was performed according to recognized consensus standards ISO 7405:2018. ISO 10993-1:2018 and ISO 10993-18:2020 in conjunction with the FDA guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"". The evaluation concludes that the material does not raise any new questions of safety or effectiveness for its intended use and indications.
રેં.9 Substantial equivalence
Based on the information provided above, Ceramir Restore QuikCap is substantially equivalent to the Riva Self Cure predicate device. It is demonstrated that the minor differences between Ceramir Restore QuikCap and Riva Self Cure do not raise any new questions of safety or effectiveness.
The substantial equivalence is based on the similarities in intended use and indications, technological characteristics, performance characteristics and principles of operation with the Riva Self Cure predicate device.
Tel: +46 (0)18 478 20 00
e-mail: info@doxa.se
§ 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.