Atlas FDA

VONFLEX PUTTY

FDA 510(k) clearance K091267 · decided 2009-05-06

Clearance details

K-number
K091267
Device name
VONFLEX PUTTY
Applicant
Vericom Co., Ltd.
Decision
Substantially Equivalent
Date received
2009-04-30
Decision date
2009-05-06
Days to decision
6 days
Clearance type
Traditional
Product code
ELW
Device class
2
Regulation number
872.3660
Medical specialty
Dental
Advisory committee
Dental
Location
Anyang-Si, Gyeonggi-Do, KR
Third-party review
Yes
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.