510(k) K181297
K181297 is an FDA 510(k) premarket notification submitted by Hdx Will Corp. for the device "DENTIOIII series (DENTIOIII, DENTIOIII-S)". The FDA issued a decision of Substantially Equivalent on Nov 21, 2018. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Hdx Will Corp. has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 21, 2018
- Date Received
- May 16, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Extraoral Source, Digital
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type
- 510(k)