Atlas FDA

Dental Electric Motor

FDA 510(k) clearance K203706 · decided 2022-01-13

Clearance details

K-number
K203706
Device name
Dental Electric Motor
Applicant
Guilin Woodpecker Medical Instrument Co., Ltd.
Decision
Substantially Equivalent
Date received
2020-12-18
Decision date
2022-01-13
Days to decision
391 days
Clearance type
Traditional
Product code
EBW
Device class
1
Regulation number
872.4200
Medical specialty
Dental
Advisory committee
Dental
Location
Guilin, CN
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.