The following data is part of a premarket notification filed by Den-mat Corp. with the FDA for Light-cured Zionomer Cement.
| Device ID | K881918 |
| 510k Number | K881918 |
| Device Name: | LIGHT-CURED ZIONOMER CEMENT |
| Classification | Cement, Dental |
| Applicant | DEN-MAT CORP. P.O. BOX 1729 Santa Maria, CA 93456 |
| Contact | Robert L Ibsen |
| Correspondent | Robert L Ibsen DEN-MAT CORP. P.O. BOX 1729 Santa Maria, CA 93456 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-09 |
| Decision Date | 1988-07-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00304040163177 | K881918 | 000 |
| D8130319823101 | K881918 | 000 |
| D8130319825101 | K881918 | 000 |
| D8130319827101 | K881918 | 000 |
| D8130319828101 | K881918 | 000 |
| D8130324911100 | K881918 | 000 |
| D8130324912100 | K881918 | 000 |
| D8130324913100 | K881918 | 000 |
| D8130324914100 | K881918 | 000 |
| D8130324915100 | K881918 | 000 |
| D8130324915500 | K881918 | 000 |
| D8130324921100 | K881918 | 000 |
| D8130325991100 | K881918 | 000 |
| D8130319822101 | K881918 | 000 |
| D8130314793000 | K881918 | 000 |
| D8130314771000 | K881918 | 000 |
| 00304040163184 | K881918 | 000 |
| 00304040163191 | K881918 | 000 |
| D813030450911B0 | K881918 | 000 |
| D8130304511100 | K881918 | 000 |
| D8130313435500 | K881918 | 000 |
| D8130313811000 | K881918 | 000 |
| D8130314575000 | K881918 | 000 |
| D8130314575200 | K881918 | 000 |
| D8130314577200 | K881918 | 000 |
| D8130314577300 | K881918 | 000 |
| D8130314585500 | K881918 | 000 |
| D8130314761100 | K881918 | 000 |
| D8130325993100 | K881918 | 000 |
| D8130325993300 | K881918 | 000 |
| D8130396225101 | K881918 | 000 |
| D8130396701000 | K881918 | 000 |
| D8130396801000 | K881918 | 000 |
| D8130396802000 | K881918 | 000 |
| D8130396812000 | K881918 | 000 |
| D8130396901100 | K881918 | 000 |
| D813132400 | K881918 | 000 |
| D813325999500 | K881918 | 000 |
| D81345060 | K881918 | 000 |
| D813LUM10050 | K881918 | 000 |
| D813UB20000 | K881918 | 000 |
| D813UB20010 | K881918 | 000 |
| D8130396224101 | K881918 | 000 |
| D8130396223101 | K881918 | 000 |
| D8130396222101 | K881918 | 000 |
| D8130325993500 | K881918 | 000 |
| D8130325993700 | K881918 | 000 |
| D8130325993800 | K881918 | 000 |
| D8130325993900 | K881918 | 000 |
| D8130325997500 | K881918 | 000 |
| D8130325999500 | K881918 | 000 |
| D8130345221010 | K881918 | 000 |
| D8130345231010 | K881918 | 000 |
| D8130345241010 | K881918 | 000 |
| D813034526101B0 | K881918 | 000 |
| D8130396201500 | K881918 | 000 |
| D8130396221101 | K881918 | 000 |
| D813UB20020 | K881918 | 000 |