IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT
FDA 510(k) clearance K113279 · decided 2011-11-14
Clearance details
- K-number
- K113279
- Device name
- IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT
- Applicant
- Kettenbach GmbH & Co. KG
- Decision
- Substantially Equivalent
- Date received
- 2011-11-07
- Decision date
- 2011-11-14
- Days to decision
- 7 days
- Clearance type
- Special
- Product code
- ELW
- Device class
- 2
- Regulation number
- 872.3660
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Eschenburg, DE
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.