510(k) K003377
K003377 is an FDA 510(k) premarket notification submitted by Ivoclar North America, Inc. for the device "FERMIT N PLUS". The FDA issued a decision of Substantially Equivalent on December 4, 2000. The device falls under product code EBG (Crown And Bridge, Temporary, Resin), a Class II device regulated under 21 CFR 872.3770. Ivoclar North America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 2000
- Date Received
- October 30, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Crown And Bridge, Temporary, Resin
- Device Class
- Class II
- Regulation Number
- 872.3770
- Review Panel
- DE
- Submission Type