The following data is part of a premarket notification filed by Professional Positioners, Inc. with the FDA for Pro-crylic Resin, Technicolor Pre-mix Monomer.
| Device ID | K943905 |
| 510k Number | K943905 |
| Device Name: | PRO-CRYLIC RESIN, TECHNICOLOR PRE-MIX MONOMER |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | PROFESSIONAL POSITIONERS, INC. 2525 THREE MILE RD. Racine, WI 53404 |
| Contact | Sandra Ivanoski |
| Correspondent | Sandra Ivanoski PROFESSIONAL POSITIONERS, INC. 2525 THREE MILE RD. Racine, WI 53404 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-11 |
| Decision Date | 1995-02-27 |