KromaFaze Singles
KromaFaze is an alginate impression material used by dentists to record the anatomy of the teeth and gums. The resulting impression is used to make a plaster model for study, treatment…
KromaFaze is an alginate impression material used by dentists to record the anatomy of the teeth and gums. The resulting impression is used to make a plaster model for study, treatment planning or fabrication of restorations such as inlays and dentures.
The material forms an elastic, irreversible hydrocolloid impression. KromaFaze includes a colour-changing feature that provides a visual guide during impression making. This product is the mint-flavoured fast-setting version supplied in single packages.
Listed Item
Dust Free Color Changing Alginate Dental Impression Material Fast Set
Storage
KromaFaze is stored at room temperature and has a shelf life of 24 months.
Who Else Makes It
Concentrated in Henan (1), Shandong (1), Jiangxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hygedent Inc. | Beijing | Beijing | Contract manufacturer | 1 |
| Zhengzhou Huaer Electro-Optics Technology Co., Ltd. | Zhengzhou | Henan | Contract manufacturer | 21 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Jiangxi Dentalbright Technology Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 12 |
| Sunrise Dental Laboratory, Ltd. | Kowloon | Hong Kong | Manufacturer | 5 |
| Chemoment Materials Co., Ltd. | Hefei | Anhui | Manufacturer | 3 |
Record
| Listed by | Kerr Corporation, United States |
|---|---|
| FDA product code | ELW |
| Device type | Material, Impression |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3660 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K160441 |
| Record published | 2017-08-31 |
| Record revised | 2021-10-11 (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 | Special storage condition: Store at room temperature in a tightly closed container. Keep Dry. Keep away from sunlight. |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 27444DX | 125 x 18g each alginate singles package | 125 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Henry Schein | Henry Schein, Inc. | 164 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 124 |
| EXAlence™ | GC America Inc. | 96 |
| MARK3 | Cargus International, Inc | 75 |
| Panasil | Kettenbach Gmbh & Co KG | 73 |
| Aquasil Ultra Smart Wetting® Impression Material Cartridge System | Dentsply LLC | 72 |
| DentMix | IPB Inc | 70 |
| Affinis | Coltène/Whaledent AG | 67 |
| Take 1 Advanced | Kerr Corporation | 54 |
| MDC Dental | MDC Dental | 49 |
| Elastomeric Impression Material | Shandong Huge Dental Material Corporation | 46 |
| Splash® | DEN-MAT Holdings, LLC | 44 |
Showing 12 of 1,245. All products under Material, Impression
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160441 | 2016-06-30 |
| K110092 | 2011-04-08 |
| K092176 | 2010-01-28 |
| K091613 | 2009-10-07 |
| K072622 | 2007-12-04 |
| K031484 | 2003-07-03 |
| K010994 | 2001-04-23 |
| K001655 | 2000-08-10 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-02-21 | Class II | Nonconforming Material/Component | The firm recalled the product because it may cure harder than expected within the shelf life, which could result in a material that may be more difficult to remove. Use of this product on patients with loose teeth may result in possible too | 45 kits and 87 refills | 2012-11-15 |
| 2010-11-04 | Not classified | Packaging process control | Pentron Clinical is voluntarily recalling the following lot of mislabeled Correct VPS Medium Body Tubes. It was discovered that the individual tubes inside the Correct VPS Medium Body Tube boxes are missing the lot/expiration date sticker. | 176 units | 2012-03-14 |
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.