FDA UDI
In Commercial Distribution
🇺🇸 United States
SM INTERNAL/EXTERNAL IMPLANT SYSTEMS
DI: 08800049287132
·
Model: SHN 2508
·
DIO Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SM INTERNAL/EXTERNAL IMPLANT SYSTEMS
- Primary DI
- 08800049287132
- Version / Model
- SHN 2508
- Catalog Number
- SHN 2508
- Company Name
- DIO Corporation
- Labeler DUNS
- 631085206
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-01
- Public Version
- 2
- Public Version Date
- 2022-11-09
- Public Version Status
- Update
- Public Device Record Key
- 00ea3c12-d707-42ae-837e-b512a7fcdfb6
Device Description
SM Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 3.8, 4.5 and 5.3mm, and lengths from 8mm to 14mm. It is placed via one or two stage surgery and the functional loading can be from immediated to delay.
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
- Yes
- PM Exempt
- No
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | Dental | 872.3630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61647 | Dental prosthesis/implant abutment screw | A device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800049287132 | GS1 |
Customer Contacts
- Phone
- 213-365-2875
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070569 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Ø3.6X1.0mm |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 30 Degrees Celsius