VERSYO.DIRECT
FDA 510(k) clearance K043295 · decided 2005-01-05
Clearance details
- K-number
- K043295
- Device name
- VERSYO.DIRECT
- Applicant
- Heraeus Kulzer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-11-29
- Decision date
- 2005-01-05
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- EBI
- Device class
- 2
- Regulation number
- 872.3760
- 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.