The following data is part of a premarket notification filed by Global Dental Products, Inc. with the FDA for Infibra, Model 1200.
| Device ID | K061735 |
| 510k Number | K061735 |
| Device Name: | INFIBRA, MODEL 1200 |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | GLOBAL DENTAL PRODUCTS, INC. 1028 MCLEAN AVE Wantagh, NY 11793 |
| Contact | Jerry Bartick |
| Correspondent | Jerry Bartick GLOBAL DENTAL PRODUCTS, INC. 1028 MCLEAN AVE Wantagh, NY 11793 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-20 |
| Decision Date | 2006-09-08 |
| Summary: | summary |