510(k) K812277
K812277 is an FDA 510(k) premarket notification submitted by Caulk Co., Div. Dentsply for the device "PRISMA-FIL COMPULES". The FDA issued a decision of Substantially Equivalent on September 8, 1981. The device falls under product code EID (Syringe, Restorative And Impression Material), a Class I device regulated under 21 CFR 872.4565. Caulk Co., Div. Dentsply has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 1981
- Date Received
- August 13, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Restorative And Impression Material
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type