OSSIX Breeze
510(k) K212509
OSSIX Breeze is a Class II device made by Datum Dental Ltd, cleared under FDA 510(k) K212509 on 18 Jul 2022, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK212509 | Date18 Jul 2022 | StatusActive |
Official records
- FDA 510(k) database K212509
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NPL
- FDA applicant
- Datum Dental, Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3930
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K212509
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| OSSIX Agile™ 68018004 | 68018004 | 07290015477345 | Width 10 mm; Length 12 mm | On the market |
| OSSIX Agile™ 68018005 | 68018005 | 07290015477352 | Width 15 mm; Length 20 mm | On the market |
| OSSIX Agile™ 68018006 | 68018006 | 07290015477369 | Width 20 mm; Length 30 mm | On the market |
| OSSIX Agile™ 68018007 | 68018007 | 07290015477376 | Width 30 mm; Length 40 mm | On the market |
| OSSIX® Breeze 68018004 | 68018004 | 07290015477307 | Width 10 mm; Length 12 mm | On the market |
| OSSIX® Breeze 68018005 | 68018005 | 07290015477314 | Width 15 mm; Length 20 mm | On the market |
| OSSIX® Breeze 68018006 | 68018006 | 07290015477321 | Width 20 mm; Length 30 mm | On the market |
| OSSIX® Breeze 68018007 | 68018007 | 07290015477338 | Width 30 mm; Length 40 mm | On the market |
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