The following data is part of a premarket notification filed by Heraeus Kulzer, Llc with the FDA for Venus Pearl Plt Refill A1.
| Device ID | K112501 |
| 510k Number | K112501 |
| Device Name: | VENUS PEARL PLT REFILL A1 |
| Classification | Material, Tooth Shade, Resin |
| Applicant | HERAEUS KULZER, LLC 300 HERAEUS WAY South Bend, IN 46614 |
| Contact | Cheryl Zimmerman |
| Correspondent | Cheryl Zimmerman HERAEUS KULZER, LLC 300 HERAEUS WAY South Bend, IN 46614 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-30 |
| Decision Date | 2011-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J014660480990 | K112501 | 000 |
| J014660481730 | K112501 | 000 |
| J014660481710 | K112501 | 000 |
| J014660481630 | K112501 | 000 |
| J014660481490 | K112501 | 000 |
| J014660481480 | K112501 | 000 |
| J014660481470 | K112501 | 000 |
| J014660481440 | K112501 | 000 |
| J014660481410 | K112501 | 000 |
| J014660480970 | K112501 | 000 |
| J014660481770 | K112501 | 000 |
| J014660481800 | K112501 | 000 |
| J014660480980 | K112501 | 000 |
| J014660481990 | K112501 | 000 |
| J014660481980 | K112501 | 000 |
| J014660481940 | K112501 | 000 |
| J014660481930 | K112501 | 000 |
| J014660481920 | K112501 | 000 |
| J014660481840 | K112501 | 000 |
| J014660481830 | K112501 | 000 |
| J014660481820 | K112501 | 000 |
| J014660480960 | K112501 | 000 |
| J014660480940 | K112501 | 000 |
| J014660480930 | K112501 | 000 |
| J014660542630 | K112501 | 000 |
| J014660538010 | K112501 | 000 |
| J014660482130 | K112501 | 000 |
| J014660482110 | K112501 | 000 |
| J014660482140 | K112501 | 000 |
| J014660481890 | K112501 | 000 |
| J014660481870 | K112501 | 000 |
| J014660481850 | K112501 | 000 |
| J014660481450 | K112501 | 000 |
| J014660690770 | K112501 | 000 |
| J014660982760 | K112501 | 000 |
| J014660480900 | K112501 | 000 |
| J014660818370 | K112501 | 000 |
| J014660818360 | K112501 | 000 |
| J014660982670 | K112501 | 000 |
| J014660982660 | K112501 | 000 |
| J014660982630 | K112501 | 000 |
| J014660982620 | K112501 | 000 |
| J014660968780 | K112501 | 000 |
| J014660982780 | K112501 | 000 |
| J014660480950 | K112501 | 000 |
| J014660481000 | K112501 | 000 |
| J014660818470 | K112501 | 000 |
| J014660968760 | K112501 | 000 |
| J014660968750 | K112501 | 000 |
| J014660968740 | K112501 | 000 |
| J014660968730 | K112501 | 000 |
| J014660968720 | K112501 | 000 |
| J014660968710 | K112501 | 000 |
| J014660968700 | K112501 | 000 |
| J014660968690 | K112501 | 000 |
| J014660968680 | K112501 | 000 |
| J014660968770 | K112501 | 000 |
| J014660968790 | K112501 | 000 |
| J014660818460 | K112501 | 000 |
| J014660818410 | K112501 | 000 |
| J01466081840 | K112501 | 000 |
| J014660818371 | K112501 | 000 |
| J014660818361 | K112501 | 000 |
| J014660968830 | K112501 | 000 |
| J014660968820 | K112501 | 000 |
| J014660968810 | K112501 | 000 |
| J014660968800 | K112501 | 000 |
| J014660968670 | K112501 | 000 |
| J014660482010 | K112501 | 000 |
| J014660482000 | K112501 | 000 |
| J014660481750 | K112501 | 000 |
| J014660481720 | K112501 | 000 |
| J014660481650 | K112501 | 000 |
| J014660481640 | K112501 | 000 |
| J014660481620 | K112501 | 000 |
| J014660481610 | K112501 | 000 |
| J014660481500 | K112501 | 000 |
| J014660481460 | K112501 | 000 |
| J014660481430 | K112501 | 000 |
| J014660481760 | K112501 | 000 |
| J014660481780 | K112501 | 000 |
| J014660481970 | K112501 | 000 |
| J014660481960 | K112501 | 000 |
| J014660481950 | K112501 | 000 |
| J014660481910 | K112501 | 000 |
| J014660481900 | K112501 | 000 |
| J014660481880 | K112501 | 000 |
| J014660481860 | K112501 | 000 |
| J014660481810 | K112501 | 000 |
| J014660481790 | K112501 | 000 |
| J014660481420 | K112501 | 000 |