JET SET 4 DENTURE REPAIR RESIN
FDA 510(k) clearance K152981 · decided 2016-09-02
Clearance details
- K-number
- K152981
- Device name
- JET SET 4 DENTURE REPAIR RESIN
- Applicant
- Lang Dental Manufacturing Company, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-10-09
- Decision date
- 2016-09-02
- Days to decision
- 329 days
- Clearance type
- Traditional
- Product code
- EBI
- Device class
- 2
- Regulation number
- 872.3760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Wheeling, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.