510(k) K100247
K100247 is an FDA 510(k) premarket notification submitted by Detax GmbH & Co. KG for the device "DETAX IMPLANTLINK SEMI". The FDA issued a decision of Substantially Equivalent on Jul 23, 2010. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Detax GmbH & Co. KG has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 23, 2010
- Date Received
- Jan 27, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cement, Dental
- Device Class
- Class II
- Regulation Number
- 872.3275
- Review Panel
- DE
- Submission Type
- 510(k)