The following data is part of a premarket notification filed by Pentron Clinical Technologies with the FDA for Rm Bond, Model J032.
| Device ID | K072830 |
| 510k Number | K072830 |
| Device Name: | RM BOND, MODEL J032 |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | PENTRON CLINICAL TECHNOLOGIES 68-70 NORTH PLAINS INDUSTRIAL ROAD Wallingford, CT 06492 |
| Contact | Greg Moreau |
| Correspondent | Greg Moreau PENTRON CLINICAL TECHNOLOGIES 68-70 NORTH PLAINS INDUSTRIAL ROAD Wallingford, CT 06492 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-03 |
| Decision Date | 2007-12-04 |
| Summary: | summary |