(123 days)
No
The device description and performance studies focus on the material properties and physical performance of a dental restorative material, with no mention of AI or ML.
Yes
The device is a restorative dental material used for filling tooth cavities, which directly treats a condition (tooth decay).
No
The device is a restorative material used for filling tooth cavities, not for diagnosing conditions.
No
The device description clearly states it is a physical material (bioceramic restorative material) in a capsule, requiring mixing and application with a physical applicator. It is not software.
Based on the provided information, Ceramir® Restore QuikCap is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is as a "self-curing bioceramic restorative material of glass ionomer type" for filling tooth cavities. This is a direct therapeutic application within the body (in vivo), not a test performed on samples taken from the body (in vitro) to diagnose a condition.
- Device Description: The description details a material that is mixed and applied directly to a tooth cavity. This is consistent with a restorative dental material, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze substances in samples from the body for diagnostic purposes.
- Performance Studies: The performance studies focus on the material's physical properties (compressive strength, radiopacity, solubility, etc.) and biological compatibility, which are relevant for a restorative material, not a diagnostic device.
IVD devices are used to perform tests on samples like blood, urine, tissue, etc., to provide information for diagnosis, monitoring, or screening. Ceramir® Restore QuikCap is a material used to repair or restore a damaged tooth structure.
N/A
Intended Use / 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
Product codes
EMA
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
- Compressive strength at 24 hours: 189 MPa
- Radiopacity: Radiopaque (2.0 mm Al)
- Maximum solubility and disintegration (Acid erosion): 0.04 mm
- Dimensional change: 1 min
- Shear bond strength against dentin: Max: 17.0 MPa
- Thermal conductivity (at 37°C): 0.75 W/m K
- Amount of heat generated during setting: 40.2°C
- Fluoride release: Continuous for at least 28 days
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image 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
1
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
2
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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3
Doxa
510(k) Summary 5 K201937
5.1 Submitter information
| Submitted by: | Doxa Dental AB
Axel Johanssons gata 4-6
SE 754 50, Uppsala, Sweden
Phone: +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 |
4
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
5
Doxa
| Parameter | Subject device
Ceramir Restore QuikCap | Primary Predicate device
Riva Self Cure (K030516) | Comparison |
|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Ceramir Restore® QuikCap is
a self-curing bioceramic
restorative material of glass
ionomer type | Riva Self Cure is a self-curing
conventional glass ionomer
restorative material | SE |
| 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
• Dentine replacement | • Non stress 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
• Dentine replacement
• Restorative in the field
using the ART technique | SE
Since the
indications of
Ceramir Restore
QuikCap is a
subset of the
cleared
indications for
Riva Self Cure,
the difference
will not affect
safety and
effectiveness of
Ceramir Restore
QuikCap. |
| Type of
Mixing | Mixed in a capsule supplied by
SDI LTD. | Mixed in a capsule supplied by
SDI LTD. | SE |
| Powder to
liquid ratio | $3.0 g/g$ | $3.2 g/g $ | SE |
| Chemical
composition | Glass ionomer/calcium
aluminate | Glass ionomer | SE
The differences
in chemical
composition do
not raise any
new questions
of safety or
effectiveness as
evaluated by
performance
testing and
biological
evaluation. |
| Compressive
strength at 24
hours | 189 MPa
Conforms to ISO 9917-1 | 171 MPa
Conforms 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 |
| Maximum
solubility and
disintegration
(Acid
erosion) | 0.04 mm
Conforms to ISO 9917-1 | Not measured by Doxa
Conforms to ISO 9917-1** | SE |
| Dimensional
change | 1 min
Conforms to ISO 9917-1 | 1:30 min *
Conforms to ISO 9917-1** | SE |
| Shear bond
strength
against dentin | Max: 17.0 MPa | Max: 8.7 MPa | SE |
| Thermal
conductivity
(at 37°C) | 0.75 W/m K | 0.58 W/m K | SE |
| Amount of
heat
generated
during setting | 40.2°C | 41.7°C | SE |
| Fluoride
release | Continuous for at least 28 days | Continuous for at least 28 days | SE |
5.7 Technological characteristics and performance data
6
7
*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