Optiglaze™
The FDA filing names Optiglaze Color, a light cured glazing material for direct and indirect composite restorations, acrylic denture bases and artificial acrylic teeth. It is indicated for…
The FDA filing names Optiglaze Color, a light cured glazing material for direct and indirect composite restorations, acrylic denture bases and artificial acrylic teeth.
It is indicated for characterizing those restorations and for obtaining surface smoothness and wear resistance on composite resin restorations, denture bases and artificial acrylic teeth.
Listed Item
OPTIGLAZE™Color Complete Set Contains: All color shades (2.6 mL each) and disposable palette; flat and round brush; and brush holder.
Material and Storage
The filing states that the material is available in 17 shades. It gives a three year shelf life and says to store it in a cool, dark place at 4 to 25 degrees Celsius.
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yamahachi Dental Material (Changshu) Co., Ltd. | Changshu | Jiangsu | Manufacturer | 9 |
Record
| Listed by | GC America Inc., United States |
|---|---|
| FDA product code | EBD |
| Device type | Coating, Filling Material, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3310 |
| Establishment | Contract manufacturer, Remanufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K133836 |
| Record published | 2016-08-01 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 39 to 77 °F; Storage environment temperature 4 to 25 °C |
| Sizes | Total volume 2.6 to 15 ml |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 002613 | Total Volume 15 ml | In distribution | |
| 008424 | Total Volume 5 ml | In distribution | |
| 008416 | Total Volume 2.6 ml | In distribution | |
| 008424 | Total Volume 5 ml | In distribution | |
| 008409 | Total Volume 2.6 ml | In distribution | |
| 008413 | Total Volume 2.6 ml | In distribution | |
| 008410 | Total Volume 2.6 ml | In distribution | |
| 008415 | Total Volume 2.6 ml | In distribution | |
| 008417 | Total Volume 2.6 ml | In distribution | |
| 001533 | 10 | In distribution | |
| 001533 | 10 | In distribution | |
| 008408 | Total Volume 2.6 ml | In distribution | |
| 008419 | Total Volume 2.6 ml | In distribution | |
| 008412 | Total Volume 2.6 ml | In distribution | |
| 008411 | Total Volume 2.6 ml | In distribution | |
| 008419 | Total Volume 2.6 ml | In distribution | |
| 008411 | Total Volume 2.6 ml | In distribution | |
| 008412 | Total Volume 2.6 ml | In distribution | |
| 008417 | Total Volume 2.6 ml | In distribution | |
| 001534 | 10 | In distribution | |
| 008409 | Total Volume 2.6 ml | In distribution | |
| 008413 | Total Volume 2.6 ml | In distribution | |
| 008418 | Total Volume 2.6 ml | In distribution | |
| 001535 | 2 | In distribution | |
| 008416 | Total Volume 2.6 ml | In distribution | |
| 008421 | Total Volume 2.6 ml | In distribution | |
| 008414 | Total Volume 2.6 ml | In distribution | |
| 008423 | Total Volume 2.6 ml | In distribution | |
| 008410 | Total Volume 2.6 ml | In distribution | |
| 008422 | Total Volume 2.6 ml | In distribution | |
| 008414 | Total Volume 2.6 ml | In distribution | |
| 002613 | Total Volume 15 ml | In distribution | |
| 008423 | Total Volume 2.6 ml | In distribution | |
| 008420 | Total Volume 2.6 ml | In distribution | |
| 008415 | Total Volume 2.6 ml | In distribution | |
| 008420 | Total Volume 2.6 ml | In distribution | |
| 008421 | Total Volume 2.6 ml | In distribution | |
| 008422 | Total Volume 2.6 ml | In distribution | |
| 008418 | Total Volume 2.6 ml | In distribution | |
| 001534 | 10 | In distribution | |
| 008425 | Total Volume 5 ml | In distribution | |
| 008408 | Total Volume 2.6 ml | In distribution | |
| 001535 | 2 | In distribution | |
| 008425 | Total Volume 5 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ID Lightcure System | ID Korea Co., Ltd. | 63 |
| Minute Stain | Taub Products | 56 |
| Rodin | PAC-Dent Inc. | 39 |
| Renamel® Flowable Microfill | Deltamed Gmbh | 27 |
| Vita Akzent® LC | Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 27 |
| Renamel® Flowable Microfill | Cosmedent, Inc. | 26 |
| Radica® | Dentsply LLC | 20 |
| SciPharm Support Self Cured Core Build-Up Restorative Reverse | Scientific Pharmaceuticals, Inc. | 18 |
| Renamel® Flowable Microhybrid | Cosmedent, Inc. | 16 |
| Glaze | Taub Products | 14 |
| Signum matrix | Kulzer SRL | 14 |
| Minute Stain – L.M.D. Elixirs | Taub Products | 12 |
Showing 12 of 100. All products under Coating, Filling Material, Resin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K133836 | 2014-03-06 |
| K052462 | 2005-10-20 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.