FDA UDI
In Commercial Distribution
🇺🇸 United States
Cure-Thru Integra Post
DI: 00348783003499
·
Model: 3001611
·
PREMIER DENTAL PRODUCTS COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Cure-Thru Integra Post
- Primary DI
- 00348783003499
- Version / Model
- 3001611
- Company Name
- PREMIER DENTAL PRODUCTS COMPANY
- Labeler DUNS
- 014789663
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2024-09-19
- Public Version
- 1
- Public Version Date
- 2024-09-27
- Public Version Status
- New
- Public Device Record Key
- 6a75232f-b1ca-4936-9759-2b0b46432b4f
Device Description
Cure-Thru Integra Post (10)- Size 4.5
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
- 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 |
|---|---|---|---|---|
| ELR | Post, Root Canal | Dental | 872.3810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38609 | Root canal post, preformed | A prefabricated endodontic rod designed for insertion into the root canal of a patient to support and retain a crown prosthesis. It is typically a solid, cylindrical, metal (e.g., stainless steel, gold alloy) piece with a proximal end appropriate to support the crown on top; it is, however, available in a variety of shapes, dimensions, and materials (e.g., ceramics, fibre-reinforced polymers). In addition, it is available in a variety of types (e.g., non-threaded, pre-threaded, or self-tapping; straight or tapered). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00348783003536 | GS1 | ||||
| Primary | 00348783003499 | GS1 |