Alloy, Amalgam
Regulation 872.3070
0510(k)s in 12 months (74 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in EJJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Southern Dental Industries, Inc. | 6 | 0 |
| Ab Ardent | 5 | 0 |
| Goldsmith & Revere, Inc. | 4 | 0 |
| Ivoclar North America, Inc. | 4 | 0 |
| Degussa AG | 3 | 0 |
| Jeneric/Pentron, Inc. | 3 | 0 |
| Johnson & Johnson Professionals, Inc. | 3 | 0 |
| Kerr Corporation (Danbury) | 3 | 0 |
| Nordiska Dental AB | 3 | 0 |
| Ardent Production Development | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2024 | Ivoclar Vivadent, Inc. Article No. NA6050411, Valiant PhD No. 1 Econo Open, Classified |
EJJ | K820389 |
| Jun 13, 2014 | Kerr Corporation Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294.
The intended use of this device is to be used as a dental restorative material in the treatment of dental caries. Terminated |
EJJ | K951663 |
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