(65 days)
No
The device description and performance studies focus on the material composition and physical properties of a dental colorant, with no mention of AI or ML.
No
The device is described as a filled paste used for modifying the shade of composite filling material, with no discernible effect on the performance of the composite beyond coloration. It does not treat or prevent disease, nor does it affect the structure or function of the body.
No
Explanation: The device, Kolor +, is described as a filled paste used for modifying the shade of composite filling materials. Its sole stated effect is coloration, and it does not perform any diagnostic function.
No
The device description clearly states that Kolor + is a "filled paste" and a "material," indicating it is a physical substance, 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 "modifying the shade of the composite." This is a cosmetic or restorative dental procedure, not a diagnostic test performed on samples taken from the human body.
- Device Description: The device is a filled paste added to composite filling material to change its color. It is described as having the same components as a previously cleared dental composite (Herculite XRV).
- Lack of Diagnostic Function: There is no mention of this device being used to diagnose a disease, condition, or state of health. It does not analyze biological samples or provide information for diagnostic purposes.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (such as blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
modifying the shade of the composite
Product codes
Not Found
Device Description
Kolor + is a filled paste containing the same components as Herculite XRV (Herculite XRV received market clearance under 510(k) K943642). The material is highly pigmented in eleven distinct shades by incorporation of the same pigments employed in XRV. The dentist will utilize this material by adding a small portion (1 - 2 drops) to a composite filling material. This effects the material only in coloration. Since the components of Kolor + are identical to XRV and the ratio of components are similar, the addition of this colorant has no discernible affect upon the performance of the composite material.
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
dentist
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)
The physical properties of Kolor + have been evaluated and compared to three predicate devices. A comparison chart of the test results has been included in exhibit E.
Kolor + has under gone biocompatibility testing at the NAmSA Laboratories testing facility. The final composition of Kolor + was evaluated for cytotoxicity. In this test it was determined that Kolor + was non-toxic. Since the components of Kolor + are the same as those used in Herculite XRV further biocompatibility testing was not necessary. All biocompatibility testing conducted to support the safety of Herculite XRV indicated that it was both non-toxic and a non-irritant. The results of the cytotoxicity test for Kolor +, the formulation for Herculite XRV and the biocompatibility testing results for Herculite XRV have been included in exhibit F.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
non-toxic, non-irritant
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.
0
MAY -8 1996
Summary of Safety and Effectiveness
Kolor + is a filled paste containing the same components as Herculite XRV (Herculite XRV received market clearance under 510(k) K943642). The material is highly pigmented in eleven distinct shades by incorporation of the same pigments employed in XRV. The dentist will utilize this material by adding a small portion (1 - 2 drops) to a composite filling material. This effects the material only in coloration. Since the components of Kolor + are identical to XRV and the ratio of components are similar, the addition of this colorant has no discernible affect upon the performance of the composite material.
There are several products currently on the market for the same intended purpose. Many of them are referred to under different names such as colorants, shade modifiers, and stains. However, all of these products have the same intended use (i.e. modifying the shade of the composite). The physical properties of Kolor + have been evaluated and compared to three predicate devices. A comparison chart of the test results has been included in exhibit E.
Kolor + has under gone biocompatibility testing at the NAmSA Laboratories testing facility. The final composition of Kolor + was evaluated for cytotoxicity. In this test it was determined that Kolor + was non-toxic. Since the components of Kolor + are the same as those used in Herculite XRV further biocompatibility testing was not necessary. All biocompatibility testing conducted to support the safety of Herculite XRV indicated that it was both non-toxic and a non-irritant. The results of the cytotoxicity test for Kolor +, the formulation for Herculite XRV and the biocompatibility testing results for Herculite XRV have been included in exhibit F.
Product literature from several equivalent products has been provided in exhibit G. Also included is a copy of the FDA 510(k) market release letter for Herculite XRV.