The following data is part of a premarket notification filed by Astron Dental Corp. with the FDA for Duraclean Denture Cleaner.
| Device ID | K852906 |
| 510k Number | K852906 |
| Device Name: | DURACLEAN DENTURE CLEANER |
| Classification | Cleaner, Denture, Mechanical |
| Applicant | ASTRON DENTAL CORP. 280 HOLDBROOK DR. Wheeling, IL 60090 |
| Contact | Robert E Muller |
| Correspondent | Robert E Muller ASTRON DENTAL CORP. 280 HOLDBROOK DR. Wheeling, IL 60090 |
| Product Code | JER |
| CFR Regulation Number | 872.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-09 |
| Decision Date | 1985-07-31 |