Ultra-Bond®
UB Plus SUP WHT DC RFL KIT R:1
3manufacturers in China registered for this device type
23catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shandong (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| Shenzhen Upcera Dental Technology Co., Ltd. | Shenzhen | Guangdong | Private-label distributor | 6 |
Record
| Listed by | DEN-MAT Holdings, LLC, United States |
|---|---|
| FDA product code | EMA |
| Device type | Cement, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3275 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2023-09-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Do not freeze; Special storage condition: Bring to room temperature prior to use; Special storage condition: Refrigerate Ultra-Bond Plus resin cement; Storage environment temperature 33 to 75 °F; Handling environment temperature 33 to 75 °F |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 031343550 | In distribution | ||
| 032599310 | In distribution | ||
| 032491550 | In distribution | ||
| 031982310 | 4 | In distribution | |
| 032491210 | In distribution | ||
| 032599110 | In distribution | ||
| 032599380 | In distribution | ||
| 032599950 | In distribution | ||
| 032491410 | In distribution | ||
| 032491510 | In distribution | ||
| 032599950 | In distribution | ||
| 032492110 | In distribution | ||
| 031982810 | 4 | In distribution | |
| 031982710 | 4 | In distribution | |
| 032599390 | In distribution | ||
| 031982510 | 4 | In distribution | |
| 032491310 | In distribution | ||
| 032599750 | In distribution | ||
| 032599370 | In distribution | ||
| 031982210 | 4 | In distribution | |
| 032599330 | In distribution | ||
| 032599350 | In distribution | ||
| 032491110 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GC Fuji II LC® | GC America Inc. | 78 |
| Equia® | GC America Inc. | 73 |
| Riva SC | SDI Ltd. | 72 |
| Denture Base | American Tooth Industries | 61 |
| Riva LC | SDI Ltd. | 59 |
| GC Fuji IX GP® | GC America Inc. | 58 |
| GlasIonomer FX-LC | Shofu Dental Corp. | 45 |
| Henry Schein | Henry Schein, Inc. | 35 |
| Esthet-X®flow Liquid Micro Hybrid | Dentsply LLC | 24 |
| Photac™ Fil Quick Aplicap™ | 3M Deutschland GmbH | 24 |
| Ketac™ Fil Plus Aplicap™ | 3M Deutschland GmbH | 23 |
| TPH®3 flow Liquid Micro Hybrid | Dentsply LLC | 22 |
Showing 12 of 780. All products under Cement, Dental
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K881918 | 1988-07-15 |
| K852196 | 1985-06-20 |
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.