DENTAL FLOSS
FDA 510(k) clearance K864832 · decided 1987-02-10
Clearance details
- K-number
- K864832
- Device name
- DENTAL FLOSS
- Applicant
- Westone Products , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1986-12-09
- Decision date
- 1987-02-10
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- JES
- Device class
- 1
- Regulation number
- 872.6390
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Westone Products
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.