I-TEC PORTABLE DENTAL OPERATORY
FDA 510(k) clearance K040153 · decided 2004-05-21
Clearance details
- K-number
- K040153
- Device name
- I-TEC PORTABLE DENTAL OPERATORY
- Applicant
- Indigenous Peoples Technology and Education Center
- Decision
- Substantially Equivalent
- Date received
- 2004-01-23
- Decision date
- 2004-05-21
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- EBW
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Dunnellon, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.