ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L
FDA 510(k) clearance K053555 · decided 2006-08-21
Clearance details
- K-number
- K053555
- Device name
- ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L
- Applicant
- Guilin Woodpecker Medical Instrument Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-12-20
- Decision date
- 2006-08-21
- Days to decision
- 244 days
- Clearance type
- Traditional
- Product code
- ELC
- Device class
- 2
- Regulation number
- 872.4850
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Flintville, TN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Guilin Woodpecker Medical Instrument Co.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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.