FDA UDI
In Commercial Distribution
🇺🇸 United States
EVOFILL DUO
DI: 08806383554909
·
Model: HEATING CONDENSER (#F / #FM)
·
DiaDent Group International
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EVOFILL DUO
- Primary DI
- 08806383554909
- Version / Model
- HEATING CONDENSER (#F / #FM)
- Catalog Number
- 4005-2075
- Company Name
- DiaDent Group International
- Labeler DUNS
- 687789453
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-26
- Public Version
- 1
- Public Version Date
- 2020-06-03
- Public Version Status
- New
- Public Device Record Key
- 54ed7027-3a96-44a0-8342-1123ce7f02be
Device Description
EvoFill Duo(Gutta percha obturation System) is an electrically powered dental device used for heating Gutta percha and placing the softened material in prepared root canals of teeth during root canal therapy.
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EKR | Plugger, Root Canal, Endodontic | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45247 | Endodontic obturation system | An assembly of devices intended to be used during endodontic treatment involving root canal obturation procedures. It may be used in a variety of modes, e.g., to provide continuous heat to the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation, and to backfill and down pack gutta-percha during endodontic root canal treatment or root canal obturation. It typically consists of a mains electricity (AC-powered) generator that regulates an electrical current used to produce resistive heat via the handpieces for the application of the heat, or extrude gutta-percha during a root canal obturation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08806383554909 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity