DIAGNOCAM
FDA 510(k) clearance K123402 · decided 2013-09-24
Clearance details
- K-number
- K123402
- Device name
- DIAGNOCAM
- Applicant
- Kaltenbach & Voigt GmbH
- Decision
- Substantially Equivalent
- Date received
- 2012-11-05
- Decision date
- 2013-09-24
- Days to decision
- 323 days
- Clearance type
- Traditional
- Product code
- NTK
- Device class
- 2
- Regulation number
- 872.1745
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Biberach / Riss, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.