(129 days)
No
The device description and performance studies focus on the material properties and mechanical performance of a dental restorative composite, with no mention of AI or ML.
No
The device is a restorative dental material used for direct restorations and core build-up, which supports the structure of teeth rather than treating a disease or condition.
No
The device is described as a restorative filling material for direct restorations, not for diagnosing conditions.
No
The device description clearly states it is a "self-adhesive dental restorative material" provided in a "powder/liquid formulation in a mixing capsule," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Class I to Class V restorations" and "Core build up." These are procedures performed directly on a patient's teeth.
- Device Description: The device is a "self-adhesive dental restorative material" used as a "restorative filling material for direct restorations." This describes a material applied to the tooth.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens.
- Anatomical Site: While not explicitly stated, the intended use clearly indicates it's applied to teeth.
- Performance Studies: The performance studies focus on material properties (strength, setting time, bond strength, wear) and biocompatibility, which are relevant to a dental restorative material, not an IVD.
Therefore, the Surefil one™ Self-adhesive Composite Hybrid is a dental restorative material used for direct application to teeth, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Class I to Class V restorations Core build up
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
The subject Surefil one™ Self-adhesive Composite Hybrid is an self- adhesive dental restorative material which is intended to be used as a restorative filling material for direct restorations. The "composite hybrid" composition of the subject device is based on resin-modified glass ionomer chemistry and is provided in a powder/liquid formulation in a mixing capsule.
The subject Surefil one™ Self-adhesive Composite Hybrid offers is available in multiple shades and exhibits the following features:
- Self-adhesiveness to enamel and dentin
- Fluoride release
- Bulk fill and dual-cure
- Radiopacity (equivalent to 2mm aluminum).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
In-vitro bench tests were performed on the Surefil one™ Self-adhesive Composite Hybrid according to the requirements in ISO 9917-2:2017 (Dentistry -Water based cements - part 2: Resin-modified cements) and internal Dentsply Sirona criteria.
Bench tests included in support of substantial equivalence of Surefil one™ Selfadhesive Composite Hybrid. Comparative tests were performed between the proposed Surefil one™ Self-adhesive Composite Hybrid and the predicate device (K130223). A summary list of testing conducted in support of substantial equivalence is as follows:
- Compressive strength
- Flexural strength
- Setting time
- Radio-opacity
- Shear bond strength to enamel
- Shear bond strength to dentin
- Shear bond strength to composite
- Enamel wear
- ACTA (Academic Center for Dentistry Amsterdam) wear test
The performance of the Surefil one™ Self-adhesive Composite Hybrid satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence.
Cytotoxicity testing was performed for Surefil one™ Self-adhesive Composite Hybrid as well as chemical analysis of leachable organic and inorganic compounds in compliance with the standard EN ISO 10993-1. The results of the biocompatibility testing and chemical analysis conducted relating to the subject Surefil one™ Self-adhesive Composite Hybrid support its substantial equivalence.
No data from human clinical studies has been included to support the substantial equivalence of the Surefil one™ Self-adhesive Composite Hybrid.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 23, 2020
Dentsply Sirona Karl Nittinger Vice President Corporate Regulatory Affairs 221 W Philadelphia Street, Suite 60W York, Pennsylvania 17401
Re: K192530
Trade/Device Name: Surefil one™ Self-adhesive Composite Hybrid Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: December 24, 2019 Received: December 26, 2019
Dear Karl Nittinger:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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)
Device Name Surefil one™ Self-adhesive Composite Hybrid
Indications for Use (Describe) Class I to Class V restorations Core build up
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)
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Traditional 510(k)- Surefil one Self-adhesive Composite Hybrid
3
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
Image /page/3/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized leaf-like shape on the left, followed by the text "Dentsply" on the top line and "Sirona" on the bottom line. The text is in a simple, sans-serif font and is a dark gray color.
510(k) SUMMARY
For: K192530
Surefil one™ Self-adhesive Composite Hybrid
1. Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
Contact Person: Karl Nittinger Email: karl.nittinger@dentsplysirona.com Telephone Number: 717-849-4424 Fax Number: 717-849-4343
Date Prepared:
20 December 2019
Dental cement
Surefil one™ Self-adhesive Composite Hybrid
2. Device Name:
- Proprietary Name: .
- Classification Name: ●
- CFR Number: ●
- Device Class: ●
- Product Code: .
- EMA
872.3275
- Predicate Device: 3.
| Predicate Device | 510(k) | Company Name |
|---|---|---|
| Primary Predicate: | ||
| Pulpdent RMGI FILL | K130223 | Pulpdent Corporation |
| Reference Device | 510k) | Company Name |
| Secondary Predicate: | ||
| GC Fuji Direct | K172382 | GC America Inc. |
-
- Description of Device:
The subject Surefil one™ Self-adhesive Composite Hybrid is an self- adhesive dental restorative material which is intended to be used as a restorative filling material for direct restorations. The "composite hybrid" composition of the subject device is based on resin-modified glass ionomer chemistry and is provided in a powder/liquid formulation in a mixing capsule.
- Description of Device:
The subject Surefil one™ Self-adhesive Composite Hybrid offers is available in multiple shades and exhibits the following features:
- · Self-adhesiveness to enamel and dentin
- · Fluoride release
- · Bulk fill and dual-cure
- · Radiopacity (equivalent to 2mm aluminum).
4
5. Indications for Use:
- Class I to Class V restorations
- . Core build up
- Substantial Equivalence: 6.
Technological Characteristics
| Proposed Device
Surefil one™
Self-adhesive
Composite Hybrid
K192530 | Primary Predicate
Device
Pulpdent RMGI FILL
K130223 | Reference Device
GC Fuji Direct
K172382 | Differences |
|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use:
• Class I to Class
V restorations
• Core build up | Indications for Use:
Resin-modified glass
ionomer preparation
used by dental
professionals as filling
material in dental
restorations | Indications for Use:
- Class III and V restorations
- Restoration of primary teeth
- Core build-up
- Cases where radiopacity is
required - Base material for Class I and
Class II cavities using a
sandwich laminate technique | The verbiage describing the indications
for Use of Surefil one™ Self-adhesive
Composite Hybrid and the primary
predicate, Pulpdent RMGI FILL is
different. The wording used by the
primary predicate (namely: "as filling
material in dental restorations")
describes a much broader field.
The reference device indications when
compared to the proposed Surefil
one™ Self-adhesive Composite Hybrid
lists the cavity classes and the core
build-up, respectively. |
| Features: | Features: | | |
| Self-adhesive composite
hybrid restorative | Resin-modified glass
ionomer
(self-adhesive since no
use of dental adhesive is
required according to the
Instructions for Use) | Resin-modified glass ionomer
(No need for etchant and adhesive) | Composite hybrid restorative is based
on resin-modified glass ionomer
chemistry. By its chemistry, resin
modified glass-ionomers exhibit self-
adhesive properties to enamel and
dentin. |
| Proposed Device
Surefil one™
Self-adhesive
Composite Hybrid
K192530 | Primary Predicate
Device
Pulpdent RMGI FILL
K130223 | Reference Device
GC Fuji Direct
K172382 | Differences |
| Powder/liquid
formulation in a mixing
capsule | Paste/paste formulation
in a double-chamber
syringe | Paste/paste formulation in a double-
chamber syringe. | The final delivery form of the proposed
device into the teeth is a paste and therefore
the same as the predicate devices. |
| Triple cure
- Light-curing
- Self-curing
- Acid-base
reaction | Triple cure - Light-curing
- Self-curing
- Acid-
base | Acid-base reaction and polymerization of
methacrylate monomers through dual cure | No difference between the proposed device
and the primary predicate device. The
reference only has dual cure feature. |
| Fluoride release | Release calcium,
phosphate and fluoride | Bioactive material with high fluoride
release | Release of calcium, release of phosphate
ions and bioactive material are not a
proposed feature for the subject device,
Surefil one™ Self- adhesive Composite
Hybrid device. |
| Sterility:
Non-sterile when used. | Sterility:
Non-sterile when used | Sterility:
Non-sterile when used | Sterility of the proposed device is identical
to the predicate and reference devices. |
| Storage Temp:
2°C - 24°C | Storage Temp:
"Cool room temperature" * | Storage Temp:
4°C - 25°C | Storage temperature differs for the proposed
device compared to the predicate and
referenced devices. Test data is included to
support that proposed device meets its identified
requirements when stored within the identified
temperature range. |
| Shelf Life:
10 months | Shelf Life:
2 years* | Shelf Life:
2 years | The initial shelf life of the proposed device is
more limited than that of the predicate and
reference devices. Shelf life data is included to
verify that the proposed device meets its
identified requirements throughout the proposed
shelf life. |
| Available Shades:
A1, A2, A3, A3.5, Bleach White | Available Shades*:
A1, A2, A3, A3.5 | Available Shades:
A1, A2, A3 | The proposed device is offered in identical
shades as the predicate with the addition of
bleach white. |
| Application System:
Pre-dosed capsule and
extruder. | Application System:
Dual chamber syringe | Application System:
Direct dispensed or manual application after
mixing. | Proposed, predicate and reference devices can
be direct dispensed. |
| * Obtained from publicly available labeling. | | | |
5
6
7. Non-Clinical Performance Data:
In-vitro bench tests were performed on the Surefil one™ Self-adhesive Composite Hybrid according to the requirements in ISO 9917-2:2017 (Dentistry -Water based cements - part 2: Resin-modified cements) and internal Dentsply Sirona criteria.
Bench tests included in support of substantial equivalence of Surefil one™ Selfadhesive Composite Hybrid. Compartative tests were performed between the proposed Surefil one™ Self-adhesive Composite Hybrid and the predicate device (K130223). A summary list of testing conducted in support of substantial equivalence is as follows:
- Compressive strength ●
- Flexural strength ●
- Setting time
- Radio-opacity ●
- Shear bond strength to enamel ●
- Shear bond strength to dentin
- Shear bond strength to composite ●
- Enamel wear ●
- . ACTA (Academic Center for Dentistry Amsterdam) wear test
The performance of the Surefil one™ Self-adhesive Composite Hybrid satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence.
Cytotoxicity testing was performed for Surefil one™ Self-adhesive Composite Hybrid as well as chemical analysis of leachable organic and inorganic compounds in compliance with the standard EN ISO 10993-1. The results of the biocompatibility testing and chemical analysis conducted relating to the subject Surefil one™ Self-adhesive Composite Hybrid support its substantial equivalence.
8. Clinical Performance Data
No data from human clinical studies has been included to support the substantial equivalence of the Surefil one™ Self-adhesive Composite Hybrid.
9. Conclusion Regarding Substantial Equivalence
The Surefil one™ Self-adhesive Composite Hybrid has the same intended use and has similar indications for use as the primary predicate Pulpdent RMGI FILL (K130223) and the secondary predicate GC Fuji Direct (K172382). Test data to verify the performance of the Surefil one™ Self-adhesive Composite Hybrid has been provided including: compressive and flexural strength, adhesion to enamel, dentin and composite, setting time, ACTA (Academic Center for Dentistry Amsterdam) wear, enamel wear and radio-opacity and the results of this testing, combined with the design and intended use comparison with the primary predicate device, support substantial equivalence.