The following data is part of a premarket notification filed by Tidi Products, Llc with the FDA for Tidisheild.
| Device ID | K132953 |
| 510k Number | K132953 |
| Device Name: | TIDISHEILD |
| Classification | Dental Barriers And Sleeves |
| Applicant | TIDI PRODUCTS, LLC 570 ENTERPRISE DR. Neenah, WI 54956 |
| Contact | Dion Brandt |
| Correspondent | Dion Brandt TIDI PRODUCTS, LLC 570 ENTERPRISE DR. Neenah, WI 54956 |
| Product Code | PEM |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-20 |
| Decision Date | 2014-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10304040051891 | K132953 | 000 |
| D76461490041 | K132953 | 000 |
| D76464099521 | K132953 | 000 |
| D76464099601 | K132953 | 000 |
| D764B63101001 | K132953 | 000 |
| D764B63101201 | K132953 | 000 |
| 20843471120839 | K132953 | 000 |
| 10843471120788 | K132953 | 000 |
| 20843471120792 | K132953 | 000 |
| 00883205026033 | K132953 | 000 |
| 00883205026040 | K132953 | 000 |
| 00883205026057 | K132953 | 000 |
| D76461489981 | K132953 | 000 |