HARD RELINER
FDA 510(k) clearance K011277 · decided 2001-06-26
Clearance details
- K-number
- K011277
- Device name
- HARD RELINER
- Applicant
- S & C Polymer GmbH
- Decision
- Substantially Equivalent
- Date received
- 2001-04-26
- Decision date
- 2001-06-26
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- EBI
- Device class
- 2
- Regulation number
- 872.3760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Elmshorn, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.