(1 days)
Not Found
No
The device description and performance studies focus on the material properties and clinical performance of a dental composite, with no mention of AI or ML technologies.
No
This device is a dental restorative composite, which is a material used to repair or restore teeth, not a device with a therapeutic effect on a disease or condition.
No
Explanation: The device is a restorative composite material used for direct placement in cavity classes and repair of teeth, not for diagnosing a condition.
No
The device description clearly states it is a "light-cured, radiopaque, resin-based nanohybrid restorative composite," which 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 clearly states that the device is a "dental restorative intended for direct placement in all cavity classes in anterior teeth." It is used to repair and restore teeth.
- Device Description: The description details a "light-cured, radiopaque, resin-based nanohybrid restorative composite" that is applied directly to the tooth.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests on bodily samples. It is a material used to physically repair a part of the body (teeth).
Therefore, this device falls under the category of a dental restorative material, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Premier's MultiMatch Universal Chameleon Restorative Composite is a nano-hybrid dental restorative intended for direct placement in all cavity classes in anterior teeth. Additional indications include repair of enamel defects, repair of provisionals, and repair of porcelain restorations, minor occlusal build-ups, and incisal abrasions.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
Premier's MultiMatch Universal Chameleon Restorative Composite is a light-cured, radiopaque, resin-based nanohybrid restorative composite. It is formulated for direct placement in any type of anterior and posterior cavity form. It is intended to be used with a dental bonding agent and can be sculpted prior to curing. Once light cured, the composite can be easily finished and polished to achieve a highly esthetic and durable restoration. Available in three chameleon shades, MultiMatch can be dispensed via a unit-dose capsule or syringe to provide a restoration with an excellent visual color match to the surrounding dentition.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior teeth
Indicated Patient Age Range
Any age patient requiring restoration or repair of teeth.
Intended User / Care Setting
Licensed Dental Professionals
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)
Non-clinical performance data included testing for mechanical strength (flexural strength, compressive strength), water sorption and solubility, depth of cure, light sensitivity, radiopacity, polymerization shrinkage, volumetric wear, and color stability according to ISO 4049:2009. Working time and gloss were also performed. Biocompatibility testing was also conducted according to ISO 10993-1:2018. The data analyzed from the various tests substantiate that MultiMatch is safe and effective as the predicate P1145 (K162257).
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.
Not Found
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
§ 872.3690 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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December 6, 2022
Premier Dental Products Company % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K223632
Trade/Device Name: Premier's MultiMatch Universal Chameleon Restorative Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: Class II Product Code: EBF Dated: December 3, 2022 Received: December 5, 2022
Dear Prithul Bom:
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.
1
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 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 mediation-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.
Michael E. Adjodha -S
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
510(k) Number (if known)
Device Name
Premier's MultiMatch Universal Chameleon Restorative Composite
Indications for Use (Describe)
Premier's MultiMatch Universal Chameleon Restorative Composite is a nano-hybrid dental restorative intended for direct placement in all cavity classes in anterior teeth. Additional indications include repair of enamel defects, repair of provisionals, and repair of porcelain restorations, minor occlusal build-ups, and incisal abrasions.
Type of Use (Select one or both, as applicable)
図 Prescription Use (Part 21 CFR 801 Subpart D) □ Over-The-Counter Use (21 CFR 801 Subpart C)
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K223632
510(k) SUMMARY
Premier Dental's MultiMatch Universal Chameleon Restorative Composite
Submitter Information
Premier Dental Products Company 1710 Romano Drive Plymouth Meeting, PA 19462
Contact Person: Jessica Huang, Director of Quality/Regulatory
Phone: 610-239-6069 Facsimile: 610-239-6171
Date Prepared: November 29, 2022
Name of Device: Premier's MultiMatch Universal Chameleon Restorative Composite Common or Usual Name: Tooth Shade Resin Material Review Panel: Division of Dental and ENT Devices (DHT1B)
Classification Name: Material, Tooth Shade, Resin Requlatory Class: 2 Product Code: EBF Regulation Number: 21 CFR §872.3690
Predicate Devices
P1145 Dental Restorative (K162257) Trade Name: SimpliShade
Device Description
Premier's MultiMatch Universal Chameleon Restorative Composite is a light-cured, radiopaque, resin-based nanohybrid restorative composite. It is formulated for direct placement in any type of anterior and posterior cavity form. It is intended to be used with a dental bonding agent and can be sculpted prior to curing. Once light cured, the composite can be easily finished and polished to achieve a highly esthetic and durable restoration. Available in three chameleon shades, MultiMatch can be dispensed via a unit-dose capsule or syringe to provide a restoration with an excellent visual color match to the surrounding dentition.
Intended Use / Indications for Use
Premier's MultiMatch Universal Chameleon Restorative Composite has the following indications for use:
Premier Multimatch Universal Chameleon Restorative Composite is a nano-hybrid dental restorative intended for direct placement in all cavity classes in anterior and posterior teeth.
4
Additional indications include repair of enamel defects, repair of provisionals and repair of porcelain restorations, minor occlusal build-ups, core build-ups, and incisal abrasions.
Summary of Technological Characteristics
Premier's MultiMatch is substantially equivalent to the predicate device, P1145 (K162257), known by Trade Name SimpliShade in terms of indications for use, composition, physical properties, and technological characteristics. Both the subject device and the predicate device are methacrylate-based resin system containing solid filler-particles to form a highly viscous paste which can be applied into a restoration preparation.
The universal dental restoratives in the predicate and subject device are both formulated with methacrylate properties of resin and fillers to undergo light-induced polymerization to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive. The composite is designed to have high mechanical strength and durability while maintaining excellent handling and esthetic characteristics.
Premier's MultiMatch formulation has been modified from the predicates to improve physical properties of mechanical strength, color stability, and reduced polymerization shrinkage.
| | P1145 SimpliShade (KAVO Kerr) | Premier's MultiMatch Universal
Chameleon Restorative Composite
(Subject Device) |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510K number | K162257 | To be assigned |
| Trade Name | SimpliShade | MultiMatch |
| Target Users | Licensed Dental Professionals | Licensed Dental Professionals |
| Device
Description | P1145 is a light-cured, esthetic, resin
based nanohybrid dental restorative
designed for direct placement in both
anterior and posterior restorations. It
is
designed to be used after placement
of a dental adhesive. Once placed,
the composite can be easily sculpted
to the desired shape, and after curing,
can easily be finished and polished to
achieve a highly esthetic restoration. | Premier's Multimatch Universal
Chameleon Restorative Composite is
a light-cured, radiopaque, resin-based
nanohybrid restorative composite. It is
formulated for direct placement in any
type of anterior and posterior cavity
form. It is intended to be used with a
dental bonding agent and can be
sculpted prior to curing. Once light
cured, the composite can be easily
finished and polished to achieve a
highly esthetic and durable
restoration. Available in three
chameleon shades, MultiMatch can
be dispensed via a unit-dose capsule
or syringe to provide a restoration with
an excellent visual color match to the
surrounding dentition. |
A table comparing the key features of the subject and predicate devices is provided below.
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| Classification
| Name | Tooth Shade Resin Material | Tooth Shade Resin Material |
|---|---|---|
| Class | 2 | 2 |
| Product Code | EBF | EBF |
| Intended Use | Dental Restorative | Dental Restorative |
| Indications for | ||
| Use | P1145, a nano-hybrid dental | |
| restorative, is indicated for direct | ||
| placement in all cavity classes in | ||
| anterior and posterior teeth. Additional | ||
| indication include: repair of enamel | ||
| defects, repair of provisionals, repair | ||
| of porcelain restorations, minor | ||
| occlusal build-ups and incisal | ||
| abrasions. | Premier MultiMatch Universal | |
| Chameleon Restorative Composite is | ||
| a nano-hybrid dental restorative | ||
| intended for direct placement in all | ||
| cavity classes in anterior and | ||
| posterior teeth. Additional indications | ||
| include repair of enamel defects, | ||
| repair of provisionals and repair of | ||
| porcelain restorations, minor occlusal | ||
| build-ups, core build-ups, and incisal | ||
| abrasions | ||
| Intended Patient | ||
| Population | Any age patient requiring restoration | |
| or repair of teeth. | Any age patient requiring restoration | |
| or repair of teeth. | ||
| Curing | ||
| Mechanism | Photo-initiation | Photo-initiation |
| Storage | Store at Room Temperature | Store at Room Temperature |
| Composition | Bis-GMA | |
| TEGDMA | ||
| Inorganic Filler | ||
| Photo- initiator | Bis-GMA | |
| TEGDMA | ||
| Inorganic Filler | ||
| Photo- initiator | ||
| Material | ||
| Compatibility | Meets Biocompatibility Requirements | Meets Biocompatibility Requirements |
| Shelf Life | Min 24 months based on accelerated | |
| data | Min 24 months based on accelerated | |
| data | ||
| Particle Size | ||
| Distribution | Nanohybrid: | |
| nano and non-nano particle | ||
| sizes of filler ranging from 0.04 to 6 | ||
| μm | Nanohybrid: | |
| Proprietary formulation of | ||
| nano and non-nano particle | ||
| sizes of filler ranging from 0.7 to 5 μm | ||
| Light Intensity | ||
| for Curing - | ||
| Halogen | 650-1000 mW/cm² | 650-1000 or Below 1000 mW/cm² |
| Light Intensity | ||
| for Curing – LED | >1000 mW/cm² | 1100 - 1300 or above 1000 mW/cm² |
| Wavelength for | ||
| Curing | 450-480 nm | 450-480 nm |
| Depth of Cure | 2mm | 2mm |
| Curing Time | Halogen - 40 seconds (dark shade) | |
| Halogen – 20 seconds (light medium | ||
| and white shade) | ||
| LED - 20 seconds (dark shade) | ||
| LED - 10 seconds (light medium and | ||
| white shade | Minimum of 20 seconds |
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Non Clinical Performance Data
Non-clinical performance data included testing for mechanical strength (flexural strength, compressive strength), water sorption and solubility, depth of cure, light sensitivity, radiopacity, polymerization shrinkage, volumetric wear, and color stability according to ISO 4049:2009. Working time and gloss were also performed. Biocompatibility testing was also conducted according to ISO 10993-1:2018. The data analyzed from the various tests substantiate that MultiMatch is safe and effective as the predicate P1145 (K162257).
Conclusions
Premier's Multimatch Universal Chameleon Restorative Composite is as safe and effective as the identified predicate device. Premiers MultiMatch has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. In addition, the minor technological differences between Premier's Multimatch and its predicate devices raise no new issues of safety or effectiveness. Non-Clinical Performance data demonstrate that Premier's Multimatch is as safe and effective as Kerr's P1145 (K162257), known by Trade Name SimpliShade. Thus, Premier's Multimatch is substantially equivalent.