FDA UDI
In Commercial Distribution
🇺🇸 United States
MACRO-LOCK POST ILLUSION X-RO 6
DI: ERTDAE6ILLUSIONXRO000
·
Model: 4590316B
·
RECHERCHES TECHNIQUES DENTAIRES
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MACRO-LOCK POST ILLUSION X-RO 6
- Primary DI
- ERTDAE6ILLUSIONXRO000
- Version / Model
- 4590316B
- Catalog Number
- 4590316B
- Company Name
- RECHERCHES TECHNIQUES DENTAIRES
- Labeler DUNS
- 260303508
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-07
- Public Version
- 1
- Public Version Date
- 2022-12-15
- Public Version Status
- New
- Public Device Record Key
- fd0941ee-4925-4e3f-96dc-6d33f53b3b58
Device Description
Root canal post
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|---|---|
| Package | ERTD45900506BV001 | HIBCC | 5 | In Commercial Distribution | ||
| Primary | ERTDAE6ILLUSIONXRO000 | HIBCC | ||||
| Package | ERTD4590316B012 | HIBCC | 2 | In Commercial Distribution |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Away from light sources