FDA UDI
In Commercial Distribution
🇺🇸 United States
Elements Gutta Percha Cartridge 10 PCS
DI: 08809455601730
·
Model: Gutta Percha, Light body 25 Gauge
·
META SYSTEMS CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Elements Gutta Percha Cartridge 10 PCS
- Primary DI
- 08809455601730
- Version / Model
- Gutta Percha, Light body 25 Gauge
- Catalog Number
- 972-2501
- Company Name
- META SYSTEMS CO., LTD.
- Labeler DUNS
- 687503532
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-30
- Public Version
- 1
- Public Version Date
- 2025-01-07
- Public Version Status
- New
- Public Device Record Key
- c263848b-54e0-47ad-a2e5-bb7464eb62fc
Device Description
The Elements™ Gutta Percha Cartridge (The Gutta Percha Cartridge) is a device that contains gutta-percha material. It is used in conjunction with the Backfill Unit of elements™ IC obturation device or with the Extruder Handpiece of the elements Obturation Unit™. The gutta-percha material is heated and extruded from the cartridge to obturate the root canal as part of an endodontic treatment procedure. The Gutta Percha Cartridge is available in Light 25 gauge, and Medium, Heavy body in 23 gauge.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EKM | Gutta-Percha | Dental | 872.3850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31872 | Natural gutta-percha | A dental material made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. This material is softened by heat and inserted into the root canal, where it hardens as it cools. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809455601730 | GS1 |