ENDODONTIC ELECTRONIC SPREADER HEATER
FDA 510(k) clearance K853183 · decided 1985-10-16
Clearance details
- K-number
- K853183
- Device name
- ENDODONTIC ELECTRONIC SPREADER HEATER
- Applicant
- Sturgeon Engineering Co.
- Decision
- Substantially Equivalent
- Date received
- 1985-07-30
- Decision date
- 1985-10-16
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- EKK
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Petrolia, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.