The following data is part of a premarket notification filed by Pulpdent Corp. Of America with the FDA for Pca Periocare Periodontal Dressing.
| Device ID | K810545 |
| 510k Number | K810545 |
| Device Name: | PCA PERIOCARE PERIODONTAL DRESSING |
| Classification | Cement, Dental |
| Applicant | PULPDENT CORP. OF AMERICA 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-27 |
| Decision Date | 1981-03-24 |