POLYDIMETHYLSILOXANE IMPRESSION MATERIAL
FDA 510(k) clearance K131510 · decided 2013-12-20
Clearance details
- K-number
- K131510
- Device name
- POLYDIMETHYLSILOXANE IMPRESSION MATERIAL
- Applicant
- Blackwell Device Consulting
- Decision
- Substantially Equivalent
- Date received
- 2013-05-24
- Decision date
- 2013-12-20
- Days to decision
- 210 days
- Clearance type
- Traditional
- Product code
- ELW
- Device class
- 2
- Regulation number
- 872.3660
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Catawba, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.