The following data is part of a premarket notification filed by Pacific Union Dental, Inc. with the FDA for Floss Holder (plastic).
| Device ID | K855113 |
| 510k Number | K855113 |
| Device Name: | FLOSS HOLDER (PLASTIC) |
| Classification | Floss, Dental |
| Applicant | PACIFIC UNION DENTAL, INC. P.O. BOX 2025 Silver Spring, MD 20902 |
| Contact | Kenneth Woo |
| Correspondent | Kenneth Woo PACIFIC UNION DENTAL, INC. P.O. BOX 2025 Silver Spring, MD 20902 |
| Product Code | JES |
| CFR Regulation Number | 872.6390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-23 |
| Decision Date | 1986-03-06 |