510(k) K973667
K973667 is an FDA 510(k) premarket notification submitted by Neodental Chemical Products Co., Ltd. for the device "VITAPEX PRE-LOADED DENTAL SYRINGE". The FDA issued a decision of Substantially Equivalent on November 6, 1997. The device falls under product code KIF (Resin, Root Canal Filling), a Class II device regulated under 21 CFR 872.3820. Neodental Chemical Products Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 1997
- Date Received
- September 25, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Resin, Root Canal Filling
- Device Class
- Class II
- Regulation Number
- 872.3820
- Review Panel
- DE
- Submission Type