510(k) K121282
K121282 is an FDA 510(k) premarket notification submitted by Addent, Inc. for the device "MICROLUX/DL MICROLUX/BLU BIO/SCREEN". The FDA issued a decision of Substantially Equivalent on July 24, 2012. The device falls under product code NXV (Diagnostic Light, Soft Tissue Detector), a Class II device regulated under 21 CFR 872.6350. Addent, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 2012
- Date Received
- April 30, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Diagnostic Light, Soft Tissue Detector
- Device Class
- Class II
- Regulation Number
- 872.6350
- Review Panel
- DE
- Submission Type
To be used as an aid in the detection or visualization of abnormalities of intraoral soft tissue. An adjunct to traditional intraoral examination by incandescent light to enhance the visualization of oral mucosal abnormalities