OPAL BOND FLOW
FDA 510(k) clearance K100301 · decided 2010-04-29
Clearance details
- K-number
- K100301
- Device name
- OPAL BOND FLOW
- Applicant
- Ultradent Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-02-03
- Decision date
- 2010-04-29
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- DYH
- Device class
- 2
- Regulation number
- 872.3750
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- South Jordan, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.