SONICWELD RX (RESORB-X)
FDA 510(k) clearance K080862 · decided 2008-07-21
Clearance details
- K-number
- K080862
- Device name
- SONICWELD RX (RESORB-X)
- Applicant
- KLS-Martin L.P.
- Decision
- Substantially Equivalent
- Date received
- 2008-03-27
- Decision date
- 2008-07-21
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- JEY
- Device class
- 2
- Regulation number
- 872.4760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Jacksonville, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch KLS-Martin L.P.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.