Prima Titanium Implant 6.0mmd/8mml
Basic Information
- Brand Name
- Prima Titanium Implant 6.0mmd/8mml
- Primary DI
- 07290112760036
- Version / Model
- A
- Catalog Number
- 110860
- Company Name
- DMI INNOVATIVE MEDICAL TECHNOLOGY LTD
- Labeler DUNS
- 649187788
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-12
- Public Version
- 1
- Public Version Date
- 2023-01-20
- Public Version Status
- New
- Public Device Record Key
- d2cf0da2-287c-4305-a1c6-5a29731d33a8
- Distribution End Date
- 2023-01-12
Device Description
"PRTI - is a self-tapping titanium dental implant, pronounced conical shape, with variable thread, with internal Hex2.43 connection. Implants are made of medical titanium alloy Ti6Al4V ASTM-136. Implants are available in diameter 3.3; 3.75; 4.2; 5.0; 6.0 mm in diameter and length 5; 6; 7; 8; 10; 11.5; 13; 16mm. The outer surface of the implant undergoes double treatment (sandblasting and acid treatment). The texture of the outer surface of the implant has micropores of 1-4 microns in size and macropores of 30-40 microns in size. The external thread of the implant has a double spiral shape. The internal connection of the implant - a internal hexagon 2.43 mmd and internal thread 1-72 UNF for all diameters. Implant complete with disposable carrier-441113 (441113S for 5-7mm short implants) and titanium cover screw-720638 (720638S for 5-7mm short implants). Used in all types of jaws. Recommended for bones of type D1, D2, D3. Implant areas - all parts of the upper and lower jaw. Indications - two-stage implantation."
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 55849 | Screw endosteal dental implant, two-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 two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, 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 |
|---|---|---|---|---|---|---|
| Primary | 07290112760036 | GS1 |
Customer Contacts
- Phone
- +1 917 2798318
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160060 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 8 | Millimeter | |
| Outer Diameter | 6 | Millimeter | |
| Device Size Text, specify | H2.43mm |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius