FDA UDI
In Commercial Distribution
🇺🇸 United States
DENTIN ONE PIECE IMPLANTS
DI: 07290113350809
·
Model: DOP-1325
·
DENTIN IMPLANTS TECHNOLOGIES LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- DENTIN ONE PIECE IMPLANTS
- Primary DI
- 07290113350809
- Version / Model
- DOP-1325
- Company Name
- DENTIN IMPLANTS TECHNOLOGIES LTD
- Labeler DUNS
- 600215680
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-10
- Public Version
- 1
- Public Version Date
- 2018-10-11
- Public Version Status
- New
- Public Device Record Key
- db3b0553-9774-461a-a3ef-d1a8d6e878c3
Device Description
One Piece dental implant D=2.5mm, L=13mm
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | Dental | 872.3640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55848 | Screw endosteal dental implant, one-piece | A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07290113351806 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 07290113350809 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120530 | 000 |