The following data is part of a premarket notification filed by Datum Dental Ltd. with the FDA for Ossix Breeze.
| Device ID | K212509 |
| 510k Number | K212509 |
| Device Name: | OSSIX Breeze |
| Classification | Barrier, Animal Source, Intraoral |
| Applicant | Datum Dental Ltd. 1 Bat Sheva St., PO Box 6170 Lod, IL 7116003 |
| Contact | Arie Goldlust |
| Correspondent | Janice Hogan Hogan Lovells US LPP 1735 Market Street Floor 23 Philladelphia, PA 19103 |
| Product Code | NPL |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-09 |
| Decision Date | 2022-07-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290015477338 | K212509 | 000 |
| 07290015477321 | K212509 | 000 |
| 07290015477314 | K212509 | 000 |
| 07290015477307 | K212509 | 000 |
| 07290015477376 | K212509 | 000 |
| 07290015477369 | K212509 | 000 |
| 07290015477352 | K212509 | 000 |
| 07290015477345 | K212509 | 000 |