510(k) K822610
K822610 is an FDA 510(k) premarket notification submitted by Syntex Dental Products, Inc. for the device "PRECAPSULED DENTAL AMALGAM". The FDA issued a decision of Substantially Equivalent on September 14, 1982. The device falls under product code DZS (Capsule, Dental, Amalgam), a Class I device regulated under 21 CFR 872.3110. Syntex Dental Products, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 1982
- Date Received
- August 30, 1982
- 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