510(k) K900342
K900342 is an FDA 510(k) premarket notification submitted by Whaledent Intl. Div. Ipco for the device "UNITY DENTAL CEMENT". The FDA issued a decision of Substantially Equivalent on May 7, 1990. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Whaledent Intl. Div. Ipco has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 7, 1990
- Date Received
- January 23, 1990
- 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