510(k) K853183
K853183 is an FDA 510(k) premarket notification submitted by Sturgeon Engineering Co. for the device "ENDODONTIC ELECTRONIC SPREADER HEATER". The FDA issued a decision of Substantially Equivalent on October 16, 1985. The device falls under product code EKK (Spreader, Pulp Canal Filling Material, Endodontic), a Class I device regulated under 21 CFR 872.4565. Sturgeon Engineering Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 1985
- Date Received
- July 30, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spreader, Pulp Canal Filling Material, Endodontic
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type