Activator, Ultraviolet, For Polymerization
Regulation 872.6070
1510(k)s in 12 months (214 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in EBZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Ivoclar Vivadent, AG | 8 | 1 |
| Monitex Industrial Co., Ltd. | 9 | 0 |
| Rolence Enterprise Co. , Ltd. | 8 | 0 |
| Ultradent Products, Inc. | 7 | 0 |
| Kerr Corp. | 6 | 0 |
| Dentsply Intl. | 5 | 0 |
| 3M Company | 4 | 0 |
| Apoza Enterprise Co., Ltd. | 4 | 0 |
| Dentmate Technology Co. , Ltd. | 4 | 0 |
| Dxm Co., Ltd. | 4 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 20, 2022 | Envisiontec US Llc PCA 4000 Curing Units, SKU number ACC-06-1000
The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers. Open, Classified |
EBZ | K201173 |
| Apr 4, 2018 | Handpiece Headquarters Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not provide specific details for intended use. Distributed by Henry Sc Open, Classified |
EBZ | K060646 |
| Jun 9, 2014 | Ivoclar Vivadent, Inc. bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe, an accessory to a dental curing light
Ultraviolet activator for polymerization for use du Terminated |
EBZ | K110756 |
| May 9, 2012 | O'Ryan Industries Inc DISPOSA-SHIELD. The Disposable Curing Shield For Your Curing Light. The disposable Disposa-Shield are sold in different sizes from 6 mm, 8 mm, 9 mm, 11 mm and 13 mm.
The devices are Intended to be Terminated |
EBZ | None listed |
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