510(k) K082668
K082668 is an FDA 510(k) premarket notification submitted by Addent, Inc. for the device "BIO-SCREEN". The FDA issued a decision of Substantially Equivalent on January 23, 2009. 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
- January 23, 2009
- Date Received
- September 12, 2008
- 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