GLUMA DESENSITIZER POWER GEL— 510(k) K093575
Substantially EquivalentHeraeus Kulzer, LLC
FDA 510(k) clearance K093575 for GLUMA DESENSITIZER POWER GEL, Substantially Equivalent on 2010-03-05. Applicant: Heraeus Kulzer, LLC. Device class: 2.
Clearance details
- Applicant
- Heraeus Kulzer, LLC
- Product code
- Code LBH
- Device class
- Class 2
- Regulation
- 21 CFR 872.3260
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South Bend, IN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.