Life Essence Universal Porcelain System— 510(k) K163251
Substantially EquivalentBlue Sky Bio
FDA 510(k) clearance K163251 for Life Essence Universal Porcelain System, Substantially Equivalent on 2017-08-04. Applicant: Blue Sky Bio. Device class: 2.
Clearance details
- Applicant
- Blue Sky Bio
- Product code
- Code EIH
- Device class
- Class 2
- Regulation
- 21 CFR 872.6660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Grayslake, IL, US
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