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 Kits.
| Device ID | K171713 |
| 510k Number | K171713 |
| Device Name: | Neodent Instrument 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 | Kevin A. Thomas PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-09 |
| Decision Date | 2018-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07899878027386 | K171713 | 000 |
| 07899878001553 | K171713 | 000 |
| 07899878001560 | K171713 | 000 |
| 07899878001577 | K171713 | 000 |
| 07899878001584 | K171713 | 000 |
| 07899878001591 | K171713 | 000 |
| 07899878001607 | K171713 | 000 |
| 07899878018445 | K171713 | 000 |
| 07899878018452 | K171713 | 000 |
| 07899878022121 | K171713 | 000 |
| 07899878022695 | K171713 | 000 |
| 07899878022701 | K171713 | 000 |
| 07899878022718 | K171713 | 000 |
| 07899878022725 | K171713 | 000 |
| 07899878001539 | K171713 | 000 |