510(k) K891186
K891186 is an FDA 510(k) premarket notification submitted by Benn Research , Ltd. for the device "REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT". The FDA issued a decision of Substantially Equivalent on April 12, 1989. The device falls under product code EHA (Aligner, Beam, X-Ray), a Class I device regulated under 21 CFR 872.1820.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 1989
- Date Received
- March 6, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Aligner, Beam, X-Ray
- Device Class
- Class I
- Regulation Number
- 872.1820
- Review Panel
- DE
- Submission Type