AMBARINO High-Class
FDA 510(k) clearance K222723 · decided 2022-09-09
Clearance details
- K-number
- K222723
- Device name
- AMBARINO High-Class
- Applicant
- Creamed GmbH & Co. Produktions- Und Handels KG
- Decision
- Substantially Equivalent
- Date received
- 2022-09-08
- Decision date
- 2022-09-09
- Days to decision
- 1 days
- Clearance type
- Traditional
- Product code
- EBF
- Device class
- 2
- Regulation number
- 872.3690
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Marburg, DE
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.