The following data is part of a premarket notification filed by Pacific Union Dental, Inc. with the FDA for Disposable 3in Check Bite Impression Trays.
| Device ID | K855112 |
| 510k Number | K855112 |
| Device Name: | DISPOSABLE 3IN CHECK BITE IMPRESSION TRAYS |
| Classification | Material, Impression |
| 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 | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-23 |
| Decision Date | 1986-03-06 |