The following data is part of a premarket notification filed by Jjgc Industria E Comercio De Materiais Dentarios S with the FDA for Neodent Implant For Orthodontic Anchorage.
| Device ID | K102769 |
| 510k Number | K102769 |
| Device Name: | NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Contact | David Collette |
| Correspondent | David Collette JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-24 |
| Decision Date | 2011-02-23 |
| Summary: | summary |