The following data is part of a premarket notification filed by Jjgc Industria E Comercio De Materiais Dentarios S.a. with the FDA for Neodent Instruments Kits.
| Device ID | K182865 |
| 510k Number | K182865 |
| Device Name: | Neodent Instruments Kits |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | JJGC Industria E Comercio De Materiais Dentarios S.A. Av. Juscelino Kubitschek De Oliveira, 3291 - CIC Curitiba, BR 81270-200 |
| Contact | Julianne De Oliveira Capucho Lechechem |
| 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 | 2018-10-11 |
| Decision Date | 2019-05-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07899878042860 | K182865 | 000 |
| 07899878033608 | K182865 | 000 |
| 07899878033592 | K182865 | 000 |
| 07899878029557 | K182865 | 000 |
| 07899878029120 | K182865 | 000 |
| 07899878029021 | K182865 | 000 |
| 07899878027379 | K182865 | 000 |
| 07899878062165 | K182865 | 000 |