The sale of this item may be subject to regulation by the U. Food and Drug Administration and state and local regulatory agencies. FDA for Curing Light: 510(K) Number: K192233, Regulation Number: 21 CFR 872.6070, Product Code: EBZ. FDA for Handpiece: 510(K) Number: K181691, Regulation Number: 872.4200, Classification Product Code: EFB, Subsequent Product Code: EGS. FDA for Scaler: 510(K) Number: K163414, Regulation Number: 872.4850, Product Code: ELC. This item is in the category “Business, Office & Industrial\Healthcare, Lab & Dental\Handpieces & Instruments\Dental Handpieces”. The seller is “dentaloem” and is located in this country: CN. This item can be shipped to all countries in Europe, all countries in continental Asia, United States, Canada, Australia.
- Model: GK-fit KAVO MULTIflex
- Classification Product Code: EFB
- 510(K) Number For Dental Handpiece: K181691
- Regulation Number for Curing Light: 21 CFR 872.6070
- 510(K) Number For Curing Light: K192233
- Product Code For Curing Light: EBZ
- 510(K) Number For Scaler: K163414
- Regulation Number For Dental Handpiece: 872.4200
- Subsequent Product Code: EGS
- Product Code For Scaler: ELC
- Regulation Number for Scaler: 872.4850
- 510(K) Number: K181691
- Regulation Number: 872.4200
- Modified Item: No
- Country/Region of Manufacture: China
- Custom Bundle: No
- Chuck Type: Push Button
- Power Source: Pneumatic/Air
- Light: LED
- Applicable Bur: 1.6mm
- Handpiece Type: High Speed
- Hose Compatibility: 6 Hole
- Brand: YUSENDENT
- Intended Use/Discipline: Dentistry
