510(k) K962680
K962680 is an FDA 510(k) premarket notification submitted by Hyunjae Corp. for the device "HYUNJAE DENTAL IMPRESSION MATERIALS". The FDA issued a decision of Substantially Equivalent on September 30, 1996. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Hyunjae Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 30, 1996
- Date Received
- July 10, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Impression
- Device Class
- Class II
- Regulation Number
- 872.3660
- Review Panel
- DE
- Submission Type