510(k) K802967
K802967 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Professionals, Inc. for the device "DISPERSALLOY-DISPERSED PHASE ALLOY SELF-". The FDA issued a decision of Substantially Equivalent on December 30, 1980. The device falls under product code DZS (Capsule, Dental, Amalgam), a Class I device regulated under 21 CFR 872.3110. Johnson & Johnson Professionals, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 1980
- Date Received
- November 21, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Capsule, Dental, Amalgam
- Device Class
- Class I
- Regulation Number
- 872.3110
- Review Panel
- DE
- Submission Type