510(k) K032603
K032603 is an FDA 510(k) premarket notification submitted by Meta Biomed Co., Ltd. for the device "METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING". The FDA issued a decision of Substantially Equivalent on Oct 7, 2003. The device falls under product code KIF (Resin, Root Canal Filling), a Class II device regulated under 21 CFR 872.3820. Meta Biomed Co., Ltd. has 20 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 7, 2003
- Date Received
- Aug 25, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device classification
- Device Name
- Resin, Root Canal Filling
- Device Class
- Class II
- Regulation Number
- 872.3820
- Review Panel
- DE
- Submission Type
- 510(k)