FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF
K Number: K123278
·
Decision Dec 7, 2012
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
11
Review Days
46
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Basic Information
- Device Name
- IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF
- K Number
- K123278
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Heraeus Kulzer, LLC
- Date Received
- October 22, 2012
- Decision Date
- December 7, 2012
- Product Code
- KLE
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | FDA class 2 | Dental |
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