510(k) K081273
K081273 is an FDA 510(k) premarket notification submitted by Sdi , Ltd. for the device "ULTRACAPS S". The FDA issued a decision of Substantially Equivalent on July 10, 2008. The device falls under product code OIV (Dental Amalgam), a Class II device regulated under 21 CFR 872.3070. Sdi , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 2008
- Date Received
- May 5, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dental Amalgam
- Device Class
- Class II
- Regulation Number
- 872.3070
- Review Panel
- DE
- Submission Type
Dental amalgam is a device that consists of a metallic alloy, such as silver, tin, copper, and zinc, that is mixed with liquid elemental mercury for the direct filling of carious lesions or structural defects in teeth