iSmile 45-1540
by Ismile Dental Products Inc.
iSmile 45-1540 is a Class II device made by Ismile Dental Products Inc., cleared under FDA 510(k) K133070 on 22 Jun 2015 and listed in FDA GUDID since 21 Jun 2023 (UDI-DI 00816419020306), 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 | Number00816419020306 | Date21 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK133070 | Date22 Jun 2015 | StatusActive |
Official records
- AccessGUDID record 00816419020306
- FDA 510(k) database K133070
Across registries
- FDA 510(k) K133070 decided 22 Jun 2015 Active
- FDA GUDID UDI-DI 00816419020306 listed 21 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K133070
- Listed FDA GUDID 00816419020306
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- iSmile
- Generic name
- Surgical/medical face mask, non-antimicrobial, single-use
- Model / Ref / Catalog
- 45-1540
- Primary DI / UDI-DI
- 00816419020306
- 510(k) Number
- FDA product code
- FXX
- GMDN term
- Surgical/medical face mask, non-antimicrobial, single-use
- Device class
- Class II
- Regulation number
- 878.4040
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code FXX (Mask, Surgical).
- Surgical Face Mask by Suzhou Janee Medical Technology Co., Ltd.
- 3M SURGICAL MASK WITH FACE SHEILD by 3M COMPANY
- ivi N3003 Surgical face Mask, ivi N6006 Surgical mask by Iob Medical, Inc.
- Hygenix by Shenzhen Hygenix Industrial Co., Ltd.
- Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield by Unicoglobal, Inc.
- Banyan USA Surgical Mask Level 3 by Banyan USA, LLC
- SURGICAL CONE MASK by Dispomed, Inc.
- FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS by Tecnol New Jersey Wound Care, Inc.
- CROSSTEX ISOFLUID Plus Surgical Earloop Mask-Blue, CROSSTEX ISOFLUID Plus Fogfree Surgical Earloop Face Mask-Blue by CROSSTEX INTERNATIONAL, INC.
- Disposable Medical Face Mask (ear loop) by Xiantao Topmed Nonwoven Protective Products Co., Ltd.