FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ADH19
K Number: K192961
·
Decision Oct 31, 2019
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
12
Review Days
9
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Basic Information
- Device Name
- ADH19
- K Number
- K192961
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3M Deutschland GmbH
- Date Received
- October 22, 2019
- Decision Date
- October 31, 2019
- Product Code
- KLE
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- Y
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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