The following data is part of a premarket notification filed by Jjgc Industria E Comercio De Materiais Dentarios S with the FDA for Neodent Graft Screw.
| Device ID | K103084 |
| 510k Number | K103084 |
| Device Name: | NEODENT GRAFT SCREW |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Contact | David J Collette |
| Correspondent | David J Collette JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-19 |
| Decision Date | 2011-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07899878007883 | K103084 | 000 |
| 07899878007753 | K103084 | 000 |
| 07899878007746 | K103084 | 000 |
| 07899878007739 | K103084 | 000 |
| 07899878007722 | K103084 | 000 |
| 07899878007715 | K103084 | 000 |
| 07899878007708 | K103084 | 000 |
| 07899878007692 | K103084 | 000 |
| 07899878007685 | K103084 | 000 |
| 07899878007678 | K103084 | 000 |
| 07899878007661 | K103084 | 000 |
| 07899878007760 | K103084 | 000 |
| 07899878007777 | K103084 | 000 |
| 07899878007876 | K103084 | 000 |
| 07899878007869 | K103084 | 000 |
| 07899878007852 | K103084 | 000 |
| 07899878007845 | K103084 | 000 |
| 07899878007838 | K103084 | 000 |
| 07899878007821 | K103084 | 000 |
| 07899878007814 | K103084 | 000 |
| 07899878007807 | K103084 | 000 |
| 07899878007791 | K103084 | 000 |
| 07899878007784 | K103084 | 000 |
| 07899878007654 | K103084 | 000 |