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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 4, 1982 | K822654 | CURING LIGHT Venture Technology, Inc. | EBZ |
| Sep 14, 1982 | K822642 | OPTILUX & VISILUX DENTAL PHOTO LAMP Demetron Research Corp. | EBZ |
| Apr 9, 1982 | K820693 | MIDWEST LIGHT WAND American Midwest | EBZ |
| Jul 28, 1981 | K811668 | KULZER TRANSLUX VISIBLE LIGHT CURING Kulzer, Inc. | EBZ |
| Jan 14, 1981 | K803209 | ELIPAR LIGHT SOURCE Espe-Premier Sales Co. | EBZ |
| Sep 16, 1980 | K801588 | CAULK PRISMA-LITE Dentsply Intl. | EBZ |
| Jun 30, 1978 | K780898 | INSTANT CURE-1 Ultra-Light Corp. | EBZ |
| Apr 28, 1978 | K780518 | ULTRANOVAR, DENTAL U.V. CURING LAMP Demetron Research Corp. | EBZ |
| Jan 3, 1978 | K772278 | FOTOFILL ACTIVATOR LIGHT Johnson & Johnson Professionals, Inc. | EBZ |
| Oct 20, 1977 | K771889 | UNIOLITE Espe Dental Products | EBZ |
| Jun 24, 1977 | K771077 | ULTRAVIOLET RAD-EMITTING LAMP Lee Pharmaceuticals | EBZ |
| Apr 15, 1977 | K770215 | ACTIVATOR LIGHT Gte Sylvania, Inc. | EBZ |
| Apr 5, 1977 | K770599 | NUVA-LITE II PHOTO-CURE UNIT Dentsply Intl. | EBZ |
| Jan 28, 1977 | K770113 | ESTILUX UV SYSTEM Degussa Dental, Inc. | EBZ |
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