Ceramir Restore QuikCap

K201937 · Doxa Dental AB · EMA · Nov 13, 2020 · Dental

Device Facts

• Record ID: K201937
• Device Name: Ceramir Restore QuikCap
• Applicant: Doxa Dental AB
• Product Code: EMA · Dental
• Decision Date: Nov 13, 2020
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Ceramir® Restore QuikCap is a self-curing bioceramic restorative material of glass ionomer type.

Device Story

Ceramir Restore QuikCap is a self-curing bioceramic restorative material (glass ionomer/calcium aluminate hybrid) used by dental professionals in clinical settings. The device consists of a plastic capsule containing separated ceramic powder and liquid. Prior to use, the capsule is activated and mixed using a high-frequency oscillating or rotating capsule mixer. The clinician uses a dedicated applicator (Ceramir Applicator 2) to extrude the mixed material into the tooth cavity. The material is shaped using conventional filling techniques and allowed to set before finishing and polishing. The device provides a radiopaque, fluoride-releasing restorative material for various dental applications, including core build-ups and temporary fillings, aiding in tooth structure restoration.

Clinical Evidence

Bench testing only. Performance evaluated per ISO 9917-1:2007 (compressive strength, radiopacity, solubility, setting time, working time, bond strength, thermal conductivity, heat generation). Biological evaluation performed per ISO 10993-1:2018, ISO 10993-18:2020, and ISO 7405:2018. No clinical data presented.

Technological Characteristics

Bioceramic restorative material (glass ionomer/calcium aluminate hybrid). Supplied in a two-compartment plastic capsule for mechanical mixing. Radiopaque. Conforms to ISO 9917-1:2007. Biocompatibility evaluated per ISO 10993 and ISO 7405. Shade A2 (Vita shade guide).

Indications for Use

Indicated for 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, and dentin replacement.

Regulatory Classification

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. 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.

Predicate Devices

• Riva Self Cure (K030516)

Reference Devices

• Ceramir Crown & Bridge (K113040)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 AB<br>Axel Johanssons gata 4-6<br>SE 754 50, Uppsala, Sweden<br>Phone: [phone] |
|----------------|-----------------------------------------------------------------------------------------------------|
| Contact: | Anna-Lisa Tiensuu |
| Phone: | [phone] |
| e-mail: | [e-mail] |
| 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: [e-mail]

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# Doxa

| Parameter | Subject device<br>Ceramir Restore QuikCap | Primary Predicate device<br>Riva Self Cure (K030516) | Comparison |
|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Ceramir Restore® QuikCap is<br>a self-curing bioceramic<br>restorative material of glass<br>ionomer type | Riva Self Cure is a self-curing<br>conventional glass ionomer<br>restorative material | SE |
| Indications<br>for use | • Non-load bearing Class I<br>and II restorations<br>• Deciduous teeth restorations<br>• Geriatric restorations<br>• Intermediate restorative and<br>base material for Class I and II<br>cavities using the sandwich<br>technique<br>• Cervical (Class V)<br>restorations<br>• Core build ups<br>• Temporary fillings<br>• Dentine replacement | • Non stress bearing Class I<br>and II restorations<br>• Deciduous teeth restorations<br>• Geriatric restorations<br>• Intermediate restorative and<br>base material for Class I and II<br>cavities using the sandwich<br>technique<br>• Cervical (Class V)<br>restorations<br>• Core build ups<br>• Temporary fillings<br>• Dentine replacement<br>• Restorative in the field<br>using the ART technique | SE<br>Since the<br>indications of<br>Ceramir Restore<br>QuikCap is a<br>subset of the<br>cleared<br>indications for<br>Riva Self Cure,<br>the difference<br>will not affect<br>safety and<br>effectiveness of<br>Ceramir Restore<br>QuikCap. |
| Type of<br>Mixing | Mixed in a capsule supplied by<br>SDI LTD. | Mixed in a capsule supplied by<br>SDI LTD. | SE |
| Powder to<br>liquid ratio | $3.0 g/g$ | $3.2 g/g *$ | SE |
| Chemical<br>composition | Glass ionomer/calcium<br>aluminate | Glass ionomer | SE<br>The differences<br>in chemical<br>composition do<br>not raise any<br>new questions<br>of safety or<br>effectiveness as<br>evaluated by<br>performance<br>testing and<br>biological<br>evaluation. |
| Compressive<br>strength at 24<br>hours | 189 MPa<br>Conforms to ISO 9917-1 | 171 MPa<br>Conforms to ISO 9917-1** | SE |
| Radio-<br>opacity | Radiopaque (2.0 mm Al)<br>Conforms to ISO 9917-1 | Radiopaque (2.5 mm Al)<br>Conforms to ISO 9917-1** | SE |
| Maximum<br>solubility and<br>disintegration<br>(Acid<br>erosion) | 0.04 mm<br>Conforms to ISO 9917-1 | Not measured by Doxa<br>Conforms to ISO 9917-1** | SE |
| Dimensional<br>change | <1% | <1% | SE |
| Acid soluble<br>lead content | 0.14 mg/kg<br>Conforms to ISO 9917-1 | Not measured by Doxa<br>Conforms to ISO 9917-1** | SE |
| Net setting<br>time | 4-6 min<br>Conforms to ISO 9917-1 | 6 min *<br>Conforms to ISO 9917-1** | SE |
| Working time | >1 min<br>Conforms to ISO 9917-1 | 1:30 min *<br>Conforms to ISO 9917-1** | SE |
| Shear bond<br>strength<br>against dentin | Max: 17.0 MPa | Max: 8.7 MPa | SE |
| Thermal<br>conductivity<br>(at 37°C) | 0.75 W/m K | 0.58 W/m K | SE |
| Amount of<br>heat<br>generated<br>during setting | 40.2°C | 41.7°C | SE |
| Fluoride<br>release | 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: [phone]

e-mail: [e-mail]