Parkell Pit and Fissure Sealant— 510(k) K243254
Substantially EquivalentParkell, Inc.
FDA 510(k) clearance K243254 for Parkell Pit and Fissure Sealant, Substantially Equivalent on 2025-08-08. Applicant: Parkell, Inc.. Device class: 2.
Clearance details
- Applicant
- Parkell, Inc.
- Product code
- Code EBC
- Device class
- Class 2
- Regulation
- 21 CFR 872.3765
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Edgewood, NJ, US
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