Aseptico AEU-14CF
Aseptico AEU-14CF is a Class I device made by Aseptico, Inc., cleared under FDA 510(k) K050201 on 18 Mar 2005 and listed in FDA GUDID since 8 Dec 2022 (UDI-DI 10817417020135), active as of 23 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 | Number10817417020135 | Date8 Dec 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK050201 | Date18 Mar 2005 | StatusActive |
Official records
- AccessGUDID record 10817417020135
- FDA 510(k) database K050201
Across registries
- FDA 510(k) K050201 decided 18 Mar 2005 Active
- FDA GUDID UDI-DI 10817417020135 listed 8 Dec 2022 Listed
Timeline
- Cleared FDA 510(k) K050201
- Listed FDA GUDID 10817417020135
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Aseptico
- Generic name
- Dental delivery system
- Model / reference
- AEU-14CF
- Primary DI / UDI-DI
- 10817417020135
- 510(k) Number
- FDA product code
- EIA
- GMDN term
- Dental delivery system
- Device class
- Class I
- Regulation number
- 872.6640
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Dental delivery system.
- CARVING 2025 by O.M.S. S.P.A. OFFICINE MECCANICHE SPECIALIZZATE
- Coltene Canalpro CL2 - by SAEYANG CO.,LTD.
- UM-1L 6680900 by CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD.
- N2 (Continental Type) MC92-0008A by Megagen Implant Co., Ltd.
- E-connect S 6080051 by CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD.
- Dental controllers for contra angle handpieces - by SAEYANG CO.,LTD.
- F1 Arcus 0140 by Fimet Oy
- PARTNER SW77030 by PROMED SRL
- CHIROMEGA s.r.o. CHIROMEGA 654 SOLO by CHIROMEGA
- NEO 0200 by Fimet Oy