Atlas FDA

CharmFlex

FDA 510(k) clearance K152766 · decided 2016-03-08

Clearance details

K-number
K152766
Device name
CharmFlex
Applicant
Dentkist, Inc.
Decision
Substantially Equivalent
Date received
2015-09-24
Decision date
2016-03-08
Days to decision
166 days
Clearance type
Traditional
Product code
ELW
Device class
2
Regulation number
872.3660
Medical specialty
Dental
Advisory committee
Dental
Location
Gunpo-Si, KR
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.