KOLOR +

K961284 · Sybron Dental Specialties, Inc. · EBF · May 8, 1996 · Dental

Device Facts

• Record ID: K961284
• Device Name: KOLOR +
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: EBF · Dental
• Decision Date: May 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2

Indications for Use

modifying the shade of the composite

Device Story

Kolor + is a highly pigmented filled paste; used by dentists to adjust shade of composite filling materials. Dentist adds small portion (1-2 drops) to composite; acts as colorant/shade modifier. Components identical to Herculite XRV (K943642); addition of pigment does not affect composite performance. Used in dental clinic setting.

Clinical Evidence

Bench testing only. Cytotoxicity testing performed at NAmSA Laboratories; determined non-toxic. Biocompatibility data for Herculite XRV referenced to support safety.

Technological Characteristics

Filled paste; highly pigmented; components identical to Herculite XRV. No specific ASTM standards or software/energy sources described.

Indications for Use

Indicated for use by dentists to modify the shade of composite filling materials.

Regulatory Classification

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.

Predicate Devices

• Herculite XRV (K943642)

Submission Summary (Full Text)

{0}

MAY - 8 1996
K961284

# 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.