The following data is part of a premarket notification filed by Crown Delta Corp. with the FDA for Dental Impression Material.
| Device ID | K821221 |
| 510k Number | K821221 |
| Device Name: | DENTAL IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | CROWN DELTA CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-27 |
| Decision Date | 1982-06-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816519021296 | K821221 | 000 |
| 00850004223017 | K821221 | 000 |
| 00850004223031 | K821221 | 000 |
| 00850004223048 | K821221 | 000 |
| 00850004223055 | K821221 | 000 |
| 00850004223062 | K821221 | 000 |
| 00850004223079 | K821221 | 000 |
| 00850004223086 | K821221 | 000 |
| 00850004223093 | K821221 | 000 |
| 00850362007007 | K821221 | 000 |
| 00850362007014 | K821221 | 000 |
| 00816519021289 | K821221 | 000 |
| 00850004223109 | K821221 | 000 |