IBOND NEXT GENERATION
FDA 510(k) clearance K051006 · decided 2005-06-07
Clearance details
- K-number
- K051006
- Device name
- IBOND NEXT GENERATION
- Applicant
- Heraeus Kulzer,GmbH
- Decision
- Substantially Equivalent
- Date received
- 2005-04-20
- Decision date
- 2005-06-07
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- KLE
- Device class
- 2
- Regulation number
- 872.3200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- South Bend, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.