OSTIM
FDA 510(k) clearance K030052 · decided 2004-12-06
Clearance details
- K-number
- K030052
- Device name
- OSTIM
- Applicant
- Heraeus Kulzer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-01-06
- Decision date
- 2004-12-06
- Days to decision
- 700 days
- Clearance type
- Traditional
- Product code
- LYC
- Device class
- 2
- Regulation number
- 872.3930
- 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.