BioMin Restore Plus
FDA 510(k) clearance K200077 · decided 2020-11-06
Clearance details
- K-number
- K200077
- Device name
- BioMin Restore Plus
- Applicant
- Dr. Collins, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-01-14
- Decision date
- 2020-11-06
- Days to decision
- 297 days
- Clearance type
- Traditional
- Product code
- LBH
- Device class
- 2
- Regulation number
- 872.3260
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.