The following data is part of a premarket notification filed by Crown Delta Corp. with the FDA for Crown Delta Silicone Impression Material.
| Device ID | K801380 |
| 510k Number | K801380 |
| Device Name: | CROWN DELTA SILICONE IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | CROWN DELTA CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-11 |
| Decision Date | 1980-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817169021155 | K801380 | 000 |
| D773290HT90061 | K801380 | 000 |
| D773290HT90031 | K801380 | 000 |
| D773290HT90021 | K801380 | 000 |
| D773290HT90011 | K801380 | 000 |
| D773290HT90001 | K801380 | 000 |
| D77329000101 | K801380 | 000 |
| D773290000121 | K801380 | 000 |
| D773290000111 | K801380 | 000 |
| D773290000091 | K801380 | 000 |
| D773290000081 | K801380 | 000 |
| D773290000071 | K801380 | 000 |
| D773290000061 | K801380 | 000 |
| D773290000051 | K801380 | 000 |
| 00816526021685 | K801380 | 000 |
| D773290HT90071 | K801380 | 000 |
| D773290HT90081 | K801380 | 000 |
| D773290HT90091 | K801380 | 000 |
| 00817169020134 | K801380 | 000 |
| 00817169020127 | K801380 | 000 |
| 00817169020110 | K801380 | 000 |
| 00817169020103 | K801380 | 000 |
| 00817169020097 | K801380 | 000 |
| 00817169020080 | K801380 | 000 |
| 00817169020073 | K801380 | 000 |
| 00817169020066 | K801380 | 000 |
| 00817169020059 | K801380 | 000 |
| 00817169020042 | K801380 | 000 |
| 00817169020035 | K801380 | 000 |
| 00817169020028 | K801380 | 000 |
| 00817169020011 | K801380 | 000 |
| 00816519021517 | K801380 | 000 |
| 00816526022446 | K801380 | 000 |