FDA UDI
In Commercial Distribution
🇺🇸 United States
ELECTROmatic PM/PC
DI: EKAV101119000
·
Model: 1.011.1900
·
KaVo Dental GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ELECTROmatic PM/PC
- Primary DI
- EKAV101119000
- Version / Model
- 1.011.1900
- Catalog Number
- PM/PC
- Company Name
- KaVo Dental GmbH
- Labeler DUNS
- 333710619
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-07
- Public Version
- 3
- Public Version Date
- 2021-11-08
- Public Version Status
- Update
- Public Device Record Key
- 3d6aa3ad-9378-48cc-b29c-953b76d0ebff
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 | EKAV101119000 | 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