PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399
FDA 510(k) clearance K100854 · decided 2010-12-09
Clearance details
- K-number
- K100854
- Device name
- PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399
- Applicant
- Premium Plus International Limited
- Decision
- Substantially Equivalent
- Date received
- 2010-03-26
- Decision date
- 2010-12-09
- Days to decision
- 258 days
- Clearance type
- Traditional
- Product code
- EGS
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Hong Kong, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.