FDA UDI
In Commercial Distribution
🇺🇸 United States
A-dec
DI: 10194665008444
·
Model: 54.0924.01
·
A-DEC, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- A-dec
- Primary DI
- 10194665008444
- Version / Model
- 54.0924.01
- Catalog Number
- 54.0924.01
- Company Name
- A-DEC, INC.
- Labeler DUNS
- 009617473
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-19
- Public Version
- 1
- Public Version Date
- 2026-02-27
- Public Version Status
- New
- Public Device Record Key
- 2447eafd-bdb7-4a8a-b15c-e5104d78cdcb
Device Description
Kit, Control Module, Midwest, OTC
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EKX | Handpiece, Direct Drive, Ac-Powered | Dental | 872.4200 | 1 |
| LQY | Locator, Root Apex | Unknown | U | |
| EBW | Controller, Foot, Handpiece And Cord | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41264 | Surgical power tool system control unit, line-powered | A mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10194665008444 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K251811 | 000 |