iSmile 25-3004
by Ismile Dental Products Inc.
iSmile 25-3004 is a Class I device made by Ismile Dental Products Inc., listed in FDA GUDID since 21 Jun 2023 (UDI-DI 00816419021587), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00816419021587 | Date21 Jun 2023 | StatusListed |
Official records
- AccessGUDID record 00816419021587
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- iSmile
- Generic name
- Medical equipment/instrument drape, single-use
- Model / Ref / Catalog
- 25-3004
- Primary DI / UDI-DI
- 00816419021587
- FDA product code
- NRU
- GMDN term
- Medical equipment/instrument drape, single-use
- Device class
- Class I
- Regulation number
- 872.6250
- GUDID distribution status
- In Commercial Distribution
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