iSD-HP
iSD-HP is a Class I device made by Nakanishi Inc., cleared under FDA 510(k) K110278 on 15 Feb 2012 and listed in FDA GUDID since 2 Dec 2020 (UDI-DI 04560264576667), active as of 20 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04560264576667 | Date2 Dec 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK110278 | Date15 Feb 2012 | StatusActive |
Official records
- AccessGUDID record 04560264576667
- FDA 510(k) database K110278
Across registries
- FDA 510(k) K110278 decided 15 Feb 2012 Active
- FDA GUDID UDI-DI 04560264576667 listed 2 Dec 2020 Listed
Timeline
- Cleared FDA 510(k) K110278
- Listed FDA GUDID 04560264576667
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Dental surgical power tool motorized handpiece/set, electric
- Model / reference
- iSD-HP
- Primary DI / UDI-DI
- 04560264576667
- 510(k) Number
- FDA product code
- EKX
- GMDN term
- Dental surgical power tool motorized handpiece/set, electric
- Device class
- Class I
- Regulation number
- 872.4200
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Dental surgical power tool motorized handpiece/set, electric.