U/P Root Canal Powder
U/P Root Canal Powder, Bulk Small Set (1/2 oz powder, 1/4 oz liquid)
3manufacturers in China registered for this device type
8catalogue numbers in this listing
20510(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 | Dentsply LLC, United States |
|---|---|
| FDA product code | EMA |
| Device type | Cement, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3275 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-21 |
| Record revised | 2024-06-04 (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. Keep out of direct sunlight. |
| Sizes | Weight 15 to 60 g; total volume 3.5 to 15 ml |
| Distribution end date | 2024-06-04 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 0011437FG | Total Volume 15 ml | Withdrawn | |
| 0011427FG | 1 Bottle (30 Capsules) | 30 | Withdrawn |
| 0011430FG | 1 Bottle Powder (15 g) | Withdrawn | |
| 0011613FG | 100 Capsules | Withdrawn | |
| 0011616FG | 30 Capsules | Withdrawn | |
| 0011615FG | 1/2 oz Powder, 1/4 oz Liquid | Withdrawn | |
| 0011435FG | Total Volume 3.5 ml | Withdrawn | |
| 0011431FG | 1 Bottle Powder (2 oz/60 g) | 12 | Withdrawn |
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 |
| Ultra-Bond® | DEN-MAT Holdings, LLC | 23 |
Showing 12 of 780. All products under Cement, Dental
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K101493 | 2010-08-19 |
| K041272 | 2004-10-18 |
| K040906 | 2004-06-16 |
| K040895 | 2004-05-21 |
| K003921 | 2001-01-24 |
| K981965 | 1998-07-10 |
| K974140 | 1998-01-05 |
| K940914 | 1994-08-29 |
| K940459 | 1994-04-29 |
| K931229 | 1993-07-08 |
| K923473 | 1993-04-12 |
| K923328 | 1992-09-09 |
| K913836 | 1991-10-17 |
| K901524 | 1990-09-19 |
| K896340 | 1990-05-15 |
| K895487 | 1990-04-02 |
| K874945 | 1988-02-19 |
| K864720 | 1987-04-07 |
| K864725 | 1987-01-21 |
| K812858 | 1981-12-31 |
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.