CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack
FDA 510(k) clearance K161042 · decided 2016-10-25
Clearance details
- K-number
- K161042
- Device name
- CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack
- Applicant
- Kuraray Noritake Dental, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-04-13
- Decision date
- 2016-10-25
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- KLE
- Device class
- 2
- Regulation number
- 872.3200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Chiyoda-Ku, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.