Infinity External Hex System 01409014
by Ace Surgical Supply Co., Inc.
Infinity External Hex System 01409014 is a Class II device made by Ace Surgical Supply Co., Inc., cleared under FDA 510(k) K954513 on 5 Jun 1996 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00614950001262), 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 | Number00614950001262 | Date24 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK954513 | Date5 Jun 1996 | StatusActive |
Official records
- AccessGUDID record 00614950001262
- FDA 510(k) database K954513
Across registries
- FDA 510(k) K954513 decided 5 Jun 1996 Active
- FDA GUDID UDI-DI 00614950001262 listed 24 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K954513
- Listed FDA GUDID 00614950001262
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Infinity External Hex System
- Generic name
- Screw endosteal dental implant, one-piece
- Model / Ref / Catalog
- 01409014
- Primary DI / UDI-DI
- 00614950001262
- 510(k) Number
- FDA product code
- DZE
- GMDN term
- Screw endosteal dental implant, one-piece
- Device class
- Class II
- Regulation number
- 872.3640
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Radiation Sterilization
- Size
- Width — 4.5 Millimeter