FDA UDI
In Commercial Distribution
🇺🇸 United States
ELECTROmatic TMC-L
DI: EKAV101285500
·
Model: 1.012.8550
·
KaVo Dental GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ELECTROmatic TMC-L
- Primary DI
- EKAV101285500
- Version / Model
- 1.012.8550
- Catalog Number
- TMC-L
- Company Name
- KaVo Dental GmbH
- Labeler DUNS
- 333710619
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-01
- Public Version
- 2
- Public Version Date
- 2021-11-08
- Public Version Status
- Update
- Public Device Record Key
- b268709a-227c-4182-b610-edb46f7c29ba
Device Description
The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.
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 |
|---|---|---|---|---|
| 34991 | Dental delivery system | A stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EKAV101285500 | HIBCC |
Customer Contacts
- Phone
- +18475506800
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163317 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius