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 Instrument Kit Cases.
| Device ID | K192670 |
| 510k Number | K192670 |
| Device Name: | Neodent Instrument Kit Cases |
| 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 | Luiza Vaccari Toppel |
| 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 | 2019-09-25 |
| Decision Date | 2019-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07899878039556 | K192670 | 000 |
| 07899878032120 | K192670 | 000 |
| 07899878032137 | K192670 | 000 |
| 07899878033578 | K192670 | 000 |
| 07899878033585 | K192670 | 000 |
| 07899878045571 | K192670 | 000 |
| 07899878045588 | K192670 | 000 |
| 07899878045595 | K192670 | 000 |
| 07899878045632 | K192670 | 000 |
| 07899878045939 | K192670 | 000 |
| 07899878054382 | K192670 | 000 |
| 07899878031628 | K192670 | 000 |