FDA UDI
In Commercial Distribution
🇺🇸 United States
EndoPilot DownPack expansion set
DI: 04260482991135
·
Model: v00
·
Schlumbohm GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EndoPilot DownPack expansion set
- Primary DI
- 04260482991135
- Version / Model
- v00
- Catalog Number
- 110 0132-US
- Company Name
- Schlumbohm GmbH & Co. KG
- Labeler DUNS
- 343831731
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-10
- Public Version
- 1
- Public Version Date
- 2021-09-20
- Public Version Status
- New
- Public Device Record Key
- 4f794a81-e9bb-4bbb-80e3-73451fe59ffc
Device Description
EndoPilot DownPack expansion set consist of: D-Pack handpiece, with LED-indicator, Heating-tip size: fine and a D-Pack/Backfill holder left
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", "High-level Disinfectant"]
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 | 04260482991135 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202906 | 000 |