FluoroCore® 2+ Dual Cure Core Build-up Material + Fast Endodontic Post Cement
FluoroCore® 2+ Introductory Kit
6manufacturers in China registered for this device type
1catalogue number
23510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jilin (2), Liaoning (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| CAO (China) Medical Equipment Company, Limited | Langfang | Hebei | Contract manufacturer | 6 |
| Sincera Technology (Changchun) Co., Ltd. | Changchun | Jilin | Manufacturer | 2 |
| Sino-Dentex Co., Ltd. | Changchun | Jilin | Manufacturer | 2 |
Record
| Listed by | Dentsply LLC, United States |
|---|---|
| FDA product code | KLE |
| Device type | Agent, Tooth Bonding, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3200 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2022-04-11 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 10 to 24 °C; Special storage condition: Syringes should be stored with the original cap only. Keep out of direct sunlight and protect from moisture. Allow mater |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 612600 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epic® | Parkell, Inc. | 22 |
| All-Bond Universal | Bisco, Inc. | 18 |
| Henry Schein | Henry Schein, Inc. | 16 |
| Peak Universal Bond | Ultradent Products Inc. | 16 |
| Brush&Bond® | Parkell, Inc. | 16 |
| All-Bond 2 | Bisco, Inc. | 15 |
| The Orthodontic Store | Young Innovations Inc. | 15 |
| All-Bond 3 | Bisco, Inc. | 13 |
| Scotchbond™ Universal | 3M Deutschland GmbH | 13 |
| Select HV Etch w/BAC | Bisco, Inc. | 12 |
| Prelude | Danville Materials, LLC | 12 |
| Jade | Dharma Research, Inc. | 12 |
Showing 12 of 609. All products under Agent, Tooth Bonding, Resin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151619 | 2015-10-30 |
| K070538 | 2007-03-14 |
| K051707 | 2005-07-15 |
| K051463 | 2005-07-12 |
| K050386 | 2005-02-23 |
| K041343 | 2004-06-16 |
| K023776 | 2003-01-23 |
| K982394 | 1998-09-21 |
| K982007 | 1998-07-22 |
| K964525 | 1997-01-22 |
| K962348 | 1996-07-18 |
| K960823 | 1996-04-26 |
| K951864 | 1995-05-23 |
| K941572 | 1994-06-10 |
| K931812 | 1993-07-08 |
| K930504 | 1993-05-27 |
| K915830 | 1992-03-02 |
| K891455 | 1989-05-18 |
| K874074 | 1987-12-29 |
| K863522 | 1986-09-19 |
| K852660 | 1985-07-25 |
| K851056 | 1985-04-22 |
| K801093 | 1980-05-20 |
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.