PROTEGE ULTRASONIC INSERT
FDA 510(k) clearance K051776 · decided 2005-07-13
Clearance details
- K-number
- K051776
- Device name
- PROTEGE ULTRASONIC INSERT
- Applicant
- Discus Dental, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-07-01
- Decision date
- 2005-07-13
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- ELC
- Device class
- 2
- Regulation number
- 872.4850
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Culver City, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.