The following data is part of a premarket notification filed by Crown Delta Corp. with the FDA for Crown Delta Hydrophilic Impression Material.
| Device ID | K041028 |
| 510k Number | K041028 |
| Device Name: | CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | CROWN DELTA CORP. 1550 FRONT ST. Yorktown Heights, NY 10598 |
| Contact | Mark P Konopka |
| Correspondent | Mark P Konopka CROWN DELTA CORP. 1550 FRONT ST. Yorktown Heights, NY 10598 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-21 |
| Decision Date | 2004-05-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7731501011 | K041028 | 000 |
| 00816519020848 | K041028 | 000 |
| 00816519020862 | K041028 | 000 |
| 00816519020886 | K041028 | 000 |
| 00816519020909 | K041028 | 000 |
| 00816519020923 | K041028 | 000 |
| 00816519020947 | K041028 | 000 |
| 00816519020961 | K041028 | 000 |
| 00816519020985 | K041028 | 000 |
| 00816519021012 | K041028 | 000 |
| 00816519021036 | K041028 | 000 |
| 00816519021074 | K041028 | 000 |
| 00816519020824 | K041028 | 000 |
| 00816519020800 | K041028 | 000 |
| D7731501021 | K041028 | 000 |
| D773150102B1 | K041028 | 000 |
| D7731501031 | K041028 | 000 |
| D773150103B1 | K041028 | 000 |
| D7731502021 | K041028 | 000 |
| D773150202B1 | K041028 | 000 |
| D7731502031 | K041028 | 000 |
| 00850362007038 | K041028 | 000 |
| 00850362007045 | K041028 | 000 |
| 00816519020770 | K041028 | 000 |
| 00816519020787 | K041028 | 000 |
| 00816519021098 | K041028 | 000 |
| 00816519021494 | K041028 | 000 |
| 00816526022026 | K041028 | 000 |
| 00816526022033 | K041028 | 000 |
| 00816526022040 | K041028 | 000 |
| 00816526022057 | K041028 | 000 |
| 10353045001790 | K041028 | 000 |
| 10353045001806 | K041028 | 000 |
| 10353045001813 | K041028 | 000 |
| 10353045001820 | K041028 | 000 |
| 10353045001837 | K041028 | 000 |
| 10353045001844 | K041028 | 000 |
| 10353045001851 | K041028 | 000 |
| 00816526022019 | K041028 | 000 |
| 00816526022002 | K041028 | 000 |
| 00816519021500 | K041028 | 000 |
| 00816519021579 | K041028 | 000 |
| 00816519021593 | K041028 | 000 |
| 00816519021630 | K041028 | 000 |
| 00816526021937 | K041028 | 000 |
| 00816526021944 | K041028 | 000 |
| 00816526021951 | K041028 | 000 |
| 00816526021968 | K041028 | 000 |
| 00816526021975 | K041028 | 000 |
| 00816526021982 | K041028 | 000 |
| 00816526021999 | K041028 | 000 |
| 10353045001868 | K041028 | 000 |