FDA UDI
In Commercial Distribution
🇺🇸 United States
EXPERTsurg LUX
DI: EKAV100835000
·
Model: 1.008.3500
·
KaVo Dental GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EXPERTsurg LUX
- Primary DI
- EKAV100835000
- Version / Model
- 1.008.3500
- Catalog Number
- NA
- Company Name
- KaVo Dental GmbH
- Labeler DUNS
- 333710619
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-26
- Public Version
- 4
- Public Version Date
- 2021-11-08
- Public Version Status
- Update
- Public Device Record Key
- 8a38b32d-36dd-4d94-a161-8983f17ee200
Device Description
This is a medical device.This is a medical device.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBW | CONTROLLER, FOOT, HANDPIECE AND CORD | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43666 | Line-powered dental drilling system | An assembly of devices designed to bore and excavate bones, teeth, and tough tissues during a dental surgical procedure. It typically consists of a motorized drill handpiece and/or motor, a control unit, and a variety of attachments used to hold the drilling/excavating endpieces (e.g., drill bits, burs, polishing disks). This system is electrically-powered from the mains (e.g., 230 or 115 volt) and supplies the handpiece/motor with low-voltage electricity (e.g., 24 volt) through a control unit. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EKAV100835000 | HIBCC |
Customer Contacts
- Phone
- +18475506800
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140308 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius