FDA UDI
In Commercial Distribution
🇺🇸 United States
Markley Threaded Wire .064
DI: D876380640
·
Model: 38064
·
ALMORE INTERNATIONAL INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Markley Threaded Wire .064
- Primary DI
- D876380640
- Version / Model
- 38064
- Catalog Number
- 38064
- Company Name
- ALMORE INTERNATIONAL INC
- Labeler DUNS
- 009051723
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-26
- Public Version
- 2
- Public Version Date
- 2019-10-23
- Public Version Status
- Update
- Public Device Record Key
- 862c4b40-d397-4246-bcfc-ed1dd3d29af3
Device Description
One foot of stainless steel threaded wire that can be cut to length for pins and posts. The smaller diameter are used for dentin pins giving better retention to amalgam fillings on vital teeth. A variety of diameters are used for endo posts to strengthen and build up endodontically treated teeth. The threaded nature of the wire provides for better retention.
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
- No
- 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 |
|---|---|---|---|---|
| EBL | Pin, Retentive And Splinting, And Accessory Instruments | Dental | 872.3740 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35868 | Dental restoration retention pin | A device intended to be placed permanently in the tooth to provide retention and/or stabilization for a dental restoration (e.g., a filling or a crown). It is typically made of stainless steel or titanium (Ti) and comes in a variety of sizes (e.g., 1.0 mm to 3.2 mm). The device is inserted into a pre-drilled hole in the tooth and is secured by threading, friction and/or cementing. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D876380640 | HIBCC |