iSmile 45-2501
by Ismile Dental Products Inc.
iSmile 45-2501 is a Class II device made by Ismile Dental Products Inc., cleared under FDA 510(k) K172280 on 3 Aug 2018 and listed in FDA GUDID since 21 Jun 2023 (UDI-DI 00816419020344), active as of 22 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 | Number00816419020344 | Date21 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK172280 | Date3 Aug 2018 | StatusActive |
Official records
- AccessGUDID record 00816419020344
- FDA 510(k) database K172280
Across registries
- FDA 510(k) K172280 decided 3 Aug 2018 Active
- FDA GUDID UDI-DI 00816419020344 listed 21 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K172280
- Listed FDA GUDID 00816419020344
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- iSmile
- Generic name
- Sterilization packaging, single-use
- Model / Ref / Catalog
- 45-2501
- Primary DI / UDI-DI
- 00816419020344
- 510(k) Number
- FDA product code
- FRG
- GMDN term
- Sterilization packaging, single-use
- Device class
- Class II
- Regulation number
- 880.6850
- GUDID distribution status
- In Commercial Distribution
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