The following data is part of a premarket notification filed by Jjgc Indústria E Comércio De Materiais Dentários S.a. with the FDA for Neodent Implant System-helix Ngm Compact Surgical Kit Cases.
| Device ID | K214051 |
| 510k Number | K214051 |
| Device Name: | Neodent Implant System-Helix NGM Compact Surgical Kit Cases |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | JJGC Indústria E Comércio De Materiais Dentários S.A. Av. Juscelino Kubitschek De Oliveira, 3291 – CIC Curitiba, BR 81270-200 |
| Contact | Thais Barboza |
| Correspondent | Jennifer M. Jackson Straumann USA, LLC 60 Minuteman Road Andover, MA 01810 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-27 |
| Decision Date | 2022-04-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07899878056348 | K214051 | 000 |
| 07899878055891 | K214051 | 000 |