510(k) clearance
Glidewell™ Denture Base Resin
- 510(k) number
- K261802
- Applicant
- Prismatik Dentalcraft, Inc.
- Decision date
- Aug 27, 2026
- Date received
- Jun 1, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- EBI
- Device type
- Resin, Denture, Relining, Repairing, Rebasing
- Device class
- Class II
- Regulation
- 21 CFR 872.3760
- Advisory committee
- Dental
- Statement or summary
- Summary
- Third party
- N
- Location
- Irvine, CA, US