RnD TE and RnD SE— 510(k) K161077
Substantially EquivalentApex Dental Materials, Inc.
FDA 510(k) clearance K161077 for RnD TE and RnD SE, Substantially Equivalent on 2017-03-17. Applicant: Apex Dental Materials, Inc.. Device class: 2.
Clearance details
- Applicant
- Apex Dental Materials, Inc.
- 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
- Traditional
- Location
- Lake Zurich, IL, US
Recent devices under product code KLE
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