The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Venus Universal Light Curing Composite.
| Device ID | K020131 |
| 510k Number | K020131 |
| Device Name: | VENUS UNIVERSAL LIGHT CURING COMPOSITE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 -2517 |
| Contact | Cheryl V Zimmerman |
| Correspondent | Cheryl V Zimmerman HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 -2517 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-15 |
| Decision Date | 2002-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J014660647970 | K020131 | 000 |
| J014660647770 | K020131 | 000 |
| J014660647780 | K020131 | 000 |
| J014660647720 | K020131 | 000 |
| J014660647730 | K020131 | 000 |
| J014660647740 | K020131 | 000 |
| J014660647760 | K020131 | 000 |
| J014660647790 | K020131 | 000 |
| J014660647800 | K020131 | 000 |
| J014660647910 | K020131 | 000 |
| J014660647920 | K020131 | 000 |
| J014660647930 | K020131 | 000 |
| J014660647940 | K020131 | 000 |
| J014660647950 | K020131 | 000 |
| J014660647960 | K020131 | 000 |
| J014660647750 | K020131 | 000 |