FDA UDI
In Commercial Distribution
🇺🇸 United States
RONDOflex plus 360
DI: EKAV100221790
·
Model: 1.002.2179
·
KaVo Dental GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RONDOflex plus 360
- Primary DI
- EKAV100221790
- Version / Model
- 1.002.2179
- Catalog Number
- plus 360
- 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
- 6
- Public Version Date
- 2021-11-08
- Public Version Status
- Update
- Public Device Record Key
- 2e54658c-8cd2-4394-9c4a-bb1edf2dad43
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
- Yes
- 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 |
|---|---|---|---|---|
| KOJ | AIRBRUSH | Dental | 872.6080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38347 | Dental power tool system handpiece, line-powered | A hand-held, mains electricity (AC-powered) dental device that includes a chuck or collet for attaching a dental endpiece (e.g., drill bit, bur, reamer, saw blade, polishing disk) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. It is powered by a low-voltage electric micro-motor (e.g., 24 volt) that is an integral part of the device; the endpiece(s) are not included. It is typically connected through the dental delivery system or a freestanding independent 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 | EKAV100221790 | HIBCC |
Customer Contacts
- Phone
- +18475506800
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042872 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius