Atlas FDA

STATIS DENTAL HANDPIECES

FDA 510(k) clearance K071891 · decided 2007-09-13

Clearance details

K-number
K071891
Device name
STATIS DENTAL HANDPIECES
Applicant
Scican , Ltd.
Decision
Substantially Equivalent
Date received
2007-07-09
Decision date
2007-09-13
Days to decision
66 days
Clearance type
Abbreviated
Product code
EFB
Device class
1
Regulation number
872.4200
Medical specialty
Dental
Advisory committee
Dental
Location
Toronto, CA
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, re recall (Z-1208-2023)Coltene Whaledent Inc2023-03-02