FDA UDI
In Commercial Distribution
🇺🇸 United States
Anthos
DI: 08033837935889
·
Model: i-MMs FLUO
·
CEFLA SOCIETA' COOPERATIVA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Anthos
- Primary DI
- 08033837935889
- Version / Model
- i-MMs FLUO
- Catalog Number
- 95520673
- Company Name
- CEFLA SOCIETA' COOPERATIVA
- Labeler DUNS
- 429341410
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-16
- Public Version
- 1
- Public Version Date
- 2026-04-24
- Public Version Status
- New
- Public Device Record Key
- f00a332d-4e59-4558-8e85-fdfee00acfba
Device Description
The CEFLA Dental Micromotors are brushless electric micromotors controlled by a control unit inside CEFLA Dental Units. They are intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear-reducing, or gear increasing speed. They are intended for professional use in dental surgery such as: preventive dentistry, restorative applications, endodontic treatment, prosthetic applications and implantology practices.
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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 66227 | Dental surgical power tool motor, electric | A hand-held, electrically-powered component of a dental power tool assembly designed to convert electrical energy into a non-dedicated mechanical energy for drilling or sawing during dental surgery. It is designed to accept handpiece components/attachments (not included) and is not intended to directly accept an endpiece (e.g., drill bit, saw blade). It might be operated with a hand- or foot-switch. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08033837935889 | GS1 |
Customer Contacts
- Phone
- +1 (704)598-0020
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230895 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 100 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity