The following data is part of a premarket notification filed by Suncoast Dental Corp. with the FDA for R & S Series Fitting Tools.
| Device ID | K811889 |
| 510k Number | K811889 |
| Device Name: | R & S SERIES FITTING TOOLS |
| Classification | Syringe, Periodontic, Endodontic, Irrigating |
| Applicant | SUNCOAST DENTAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EIC |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-01 |
| Decision Date | 1981-07-24 |