FDA UDI
In Commercial Distribution
🇺🇸 United States
SM INTERNAL/EXTERNAL IMPLANT SYSTEMS
DI: 08800049273708
·
Model: RMI 48001
·
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
- 08800049273708
- Version / Model
- RMI 48001
- Catalog Number
- RMI 48001
- 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
- 782f03db-0cad-483c-928c-a486b29d96e3
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 |
|---|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61642 | Dental implant analog | A device intended to be used as a copy of a dental implant, for a dental laboratory working model, to duplicate the location and restorative platform orientation of the final dental implant; it is not intended for intraoral use. It is a rod-like device made of metal [e.g., titanium (Ti)]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800049273708 | 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 | Ø4.8X10.0mm |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 30 Degrees Celsius