IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF— 510(k) K123278
Substantially EquivalentHeraeus Kulzer, LLC
FDA 510(k) clearance K123278 for IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF, Substantially Equivalent on 2012-12-07. Applicant: Heraeus Kulzer, LLC. Device class: 2.
Clearance details
- Applicant
- Heraeus Kulzer, LLC
- Product code
- Code KLE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- South Bend, IN, US
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