Sledgehammer
HC 25 lb Pwd & 4 Qt Liq Kit, Lt Reddish Pink
14manufacturers in China registered for this device type
70catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (6), Zhejiang (2), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Shen FU Arts LAB | Shen Zhen | Guangdong | Manufacturer | 15 |
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Riton 3D Technology Co., Ltd. | Guangzhou | Guangdong | Repacker / relabeller | 9 |
| Yamahachi Dental Material (Changshu) Co., Ltd. | Changshu | Jiangsu | Manufacturer | 9 |
| Guangzhou Heygears Imc.inc | Guangzhou | Guangdong | Specification developer | 8 |
| Hangzhou SHINING3D Dental Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
| Ningbo Sezen Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Hunan Vsmile Biotechnology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 6 |
| Shenzhen Piocreat 3D Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Showing 12 of 14. All 14 manufacturers in China registered for Resin, Denture, Relining, Repairing, Rebasing
Record
| Listed by | Keystone Industries, United States |
|---|---|
| FDA product code | EBI |
| Device type | Resin, Denture, Relining, Repairing, Rebasing |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3760 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K983876 |
| Record published | 2016-09-15 |
| Record revised | 2023-11-06 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep out of direct sunlight; Storage environment temperature 32 to 86 °F; Storage environment temperature 0 to 30 °C; Special storage condition: Keep away from moisture |
| Sizes | Weight 1 to 100 lb; weight 0.45 to 11.34 kg; total volume 8 to 32 Fluid Ounce; total volume 0.25 to 0.95 l; total volume 1 Gallon |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1000484 | In distribution | |
| 1000547 | Weight 1 lb | In distribution |
| 1000473 | In distribution | |
| 1000490 | In distribution | |
| 1000510 | Weight 0.45 kg | In distribution |
| 1000498 | Weight 0.45 kg | In distribution |
| 1000471 | In distribution | |
| 1000541 | In distribution | |
| 1000535 | In distribution | |
| 1000546 | Weight 100 lb | In distribution |
| 1001962 | Weight 2.27 kg | In distribution |
| 1000523 | Total Volume 1 Gallon | In distribution |
| 1000508 | Weight 5 lb | In distribution |
| 1000476 | In distribution | |
| 1000536 | In distribution | |
| 1000478 | In distribution | |
| 1000590 | Total Volume 8 Fluid Ounce | In distribution |
| 1000486 | In distribution | |
| 1001975 | In distribution | |
| 1000496 | Weight 11.34 kg | In distribution |
| 1000540 | In distribution | |
| 1000544 | Weight 2.27 kg | In distribution |
| 1001972 | Weight 11.34 kg | In distribution |
| 1000472 | In distribution | |
| 1000499 | Weight 2.27 kg | In distribution |
| 1001961 | Weight 0.45 kg | In distribution |
| 1000479 | In distribution | |
| 1000487 | In distribution | |
| 1000543 | Weight 0.45 kg | In distribution |
| 1000511 | Weight 2.27 kg | In distribution |
| 1000512 | Weight 25 lb | In distribution |
| 1000494 | Weight 0.45 kg | In distribution |
| 1001965 | In distribution | |
| 1000497 | Weight 100 lb | In distribution |
| 1000539 | In distribution | |
| 1000548 | Weight 2.27 kg | In distribution |
| 1000483 | In distribution | |
| 1000517 | Total Volume 32 Fluid Ounce | In distribution |
| 1000474 | In distribution | |
| 1000475 | In distribution | |
| 1000485 | In distribution | |
| 1001966 | In distribution | |
| 1000518 | Total Volume 1 Gallon | In distribution |
| 1000545 | Weight 25 lb | In distribution |
| 1000488 | In distribution | |
| 1000514 | Weight 2.27 kg | In distribution |
| 1000507 | Weight 1 lb | In distribution |
| 1000513 | Weight 1 lb | In distribution |
| 1000482 | In distribution | |
| 1000515 | Weight 11.34 kg | In distribution |
| 1000502 | Weight 1 lb | In distribution |
| 1000521 | Total Volume 0.25 l | In distribution |
| 1000489 | In distribution | |
| 1001963 | Weight 25 lb | In distribution |
| 1000477 | In distribution | |
| 1001971 | Weight 2.27 kg | In distribution |
| 1001974 | In distribution | |
| 1000504 | Weight 25 lb | In distribution |
| 1001967 | In distribution | |
| 1000516 | Total Volume 0.25 l | In distribution |
| 1001973 | In distribution | |
| 1000503 | Weight 5 lb | In distribution |
| 1000470 | In distribution | |
| 1000509 | Weight 25 lb | In distribution |
| 1001970 | Weight 0.45 kg | In distribution |
| 1000500 | Weight 25 lb | In distribution |
| 1000549 | Weight 11.34 kg | In distribution |
| 1000495 | Weight 5 lb | In distribution |
| 1000522 | Total Volume 32 Fluid Ounce | In distribution |
| 1000591 | Total Volume 0.95 l | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vertex-Dental BV | Vertex-Dental B.V. | 760 |
| HI-I® | Fricke International, Inc. | 490 |
| Vitacrilic® | Fricke International, Inc. | 249 |
| Nature-Cryl® | GC America Inc. | 205 |
| Nobilium | Cmp Industries, LLC | 167 |
| Hygenic | Coltene/Whaledent Gmbh & Co. KG | 152 |
| AvaDent | Global Dental Science | 150 |
| Dentorium | Wright Medical Technology, Inc. | 137 |
| Duracetal | The Myerson Company Limited | 136 |
| RE-Fine Bright | Yamahachi Dental MFG. Co. | 134 |
| Axcent Acrylics | Garreco, LLC | 132 |
| Unbreakable by TCS | Thermoplastic Comfort SYS | 96 |
Showing 12 of 3,288. All products under Resin, Denture, Relining, Repairing, Rebasing
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250489 | 2025-05-20 |
| K241089 | 2024-10-24 |
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.