POLYDIMETHYLSILOXANE IMPRESSION MATERIAL— 510(k) K131510
Substantially EquivalentBlackwell Device Consulting
FDA 510(k) clearance K131510 for POLYDIMETHYLSILOXANE IMPRESSION MATERIAL, Substantially Equivalent on 2013-12-20. Applicant: Blackwell Device Consulting. Device class: 2.
Clearance details
- Applicant
- Blackwell Device Consulting
- Product code
- Product code ELW
- Device class
- Class 2
- Regulation
- 21 CFR 872.3660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Catawba, NC, US
Recent devices under product code ELW
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