(275 days)
Not Found
No
The summary describes a dental composite material and its physical properties, with no mention of AI or ML.
No
The device is a dental restorative material (composite) used for filling cavities and other aesthetic dental procedures, which are generally considered treatments rather than therapeutic interventions aimed at curing diseases or disorders.
No
The device, "XP Composite," is a light cure composite used for restorative dental procedures. Its intended uses (e.g., restorations, veneering, splinting, sealing) are all therapeutic or preventative, not diagnostic.
No
The device description explicitly states "XP Composite" is a light cure composite, which is a physical material used for dental restorations, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to the restoration and repair of teeth. These are procedures performed directly on the patient's body, not on samples taken from the body for diagnostic purposes.
- Device Description: The device is described as a "light cure composite," which is a material used in dental restorations.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
- Restoration of deciduous teeth
- Posterior restorations (class I and II)
- Anterior restorations (class III and IV)
- Class V restorations
- Veneering of discoloured anterior teeth
- Splinting of mobile teeth
- Extended fissure sealing in molars and premolars
- Repair of composite and ceramic veneers
Product codes
EBF
Device Description
"XP Composite" is a light cure composite.
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
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance data for this device included the following: compressive strength, working time, consistency and radiopacity.
Testing also included water sorption, water solubility, flexural strength and depth of cure were all tested according to ISO 4049.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains 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.
July 3, 2019
S&C Polymer Silicon- und Composite Spezialitaeten GmbH Christian Boettcher Offical Correspondent to FDA, Reg. Compliance Officer Robert-Bosch-Str. 2 Elmshorn, 25335 GERMANY
Re: K182780
Trade/Device Name: XP Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: April 4, 2019 Received: April 8, 2019
Dear Christian Boettcher:
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,
Srinivas Nandkumar, Ph.D. Acting Assistant 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K182780
Device Name
XP Composite
Indications for Use (Describe)
- Restoration of deciduous teeth
- Posterior restorations (class I and II)
- Anterior restorations (class III and IV)
- Class V restorations
- Veneering of discoloured anterior teeth
- Splinting of mobile teeth
- Extended fissure sealing in molars and premolars
- Repair of composite and ceramic veneers
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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510(k) Summary
K182780
Submitter
| Name of Company: | S&C Polymer Silicon- und Composite Spezialitaeten GmbH |
|---|---|
| Address: | Robert-Bosch-Strasse 2, D-25335 Elmshorn (Germany) |
| Phone: | 0049 4121 483 0 |
| Fax: | 0049 4121 483 184 |
| Contact Person: | Dr. Christian Boettcher |
| Date of Preparation: | 01. April 2019 |
| Device Name: | |
| Trade Name: | XP Composite |
| Common Name: | Dental restorative material |
Classification Name: Material, Tooth Shade, Resin, per 21CFR § 872.3690 Classification: ll Product Code: EBF
Devices for which Substantial Equivalence is Claimed:
Tetric EvoCeram (Ivoclar Vivadent), K042819
Device Description:
"XP Composite" is a light cure composite.
Intended Use of the Devices:
"XP Composite" as well as "Tetric EvoCeram" (Ivoclar Vivadent) are light cure resin based dental restorative materials.
Indication for Use of the Devices:
The indications for use of "XP Composite" as well as "Tetric EvoCeram" (Ivoclar Vivadent) are identical and are as follows:
| | Subject Device
XP Composite | Predicate Device
Tetric EvoCeram |
|--------------------------------------------------|--------------------------------|-------------------------------------|
| Restoration of deciduous teeth | yes | yes |
| Posterior restorations (class I and II) | yes | yes |
| Anterior restorations (class III, IV) | yes | yes |
| Class V restorations | yes | yes |
| Veneering of discoloured anterior teeth | yes | yes |
| Splinting of mobile teeth | yes | yes |
| Extended fissure sealing in molars and premolars | yes | yes |
| Repair of composite and ceramic veneers | yes | yes |
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Performance Data:
Non-clinical performance data for this device included the following: compressive strength, working time, consistency and radiopacity.
Testing also included water sorption, water solubility, flexural strength and depth of cure were all tested according to ISO 4049.
Technological Characteristics:
| Subject device | Predicate device | |
|---|---|---|
| XP Composite | Tetric EvoCeram | |
| Appearance | paste | paste |
| Form of delivery | black syringe | |
| application tips | black syringe | |
| application tips | ||
| Method of polymerization | light cure | light cure |
| Application | extrusion via pressure | |
| (onto the back of the syringe | ||
| resp. onto the back of the tip) | ||
| followed by application | extrusion via pressure | |
| (onto the back of the syringe | ||
| resp. onto the back of the tip) | ||
| followed by application | ||
| Ingredients (general description) | methacrylate-based resins | |
| photo initiators | ||
| fillers | ||
| pigments | methacrylate-based resins | |
| photo initiators | ||
| fillers | ||
| pigments | ||
| Mechanism of Action | application | |
| light curing | application | |
| light curing |
Conclusion:
In regard to the intended use, the indication for use, the target population, the anatomical sites, the design, the performance, the standards to be met, the materials, and the biocompatibility the product of this submission is substantially equivalent to the predicate device.