DIO PROTEM IMPLANT SYSTEMS
Basic Information
- Brand Name
- DIO PROTEM IMPLANT SYSTEMS
- Primary DI
- 08800049273517
- Version / Model
- MAP 3010
- Catalog Number
- MAP 3010
- 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
- 692ac9c9-6dc7-481d-b912-f43f4145abdd
Device Description
The DIO Protem Implant System consist of Dental Implant, Superstructure, Prosthetics and Surgical Instruments. The Protem Implants is an integrated system of endosseous dental implants which increas indurance of temporary tooth and to conduct the immediate functions and immediate recovery of aesthetics of osteoimplanted area. These are made of titanium alloy which have a sand-blasted, RBM(Resorbable Blast Media) treated surface. These implants are consist of one-stage, root-form dental implant which provide the clinician to maintain the patients` gingival contour. The Implants have the diameter(2.0/2.5mm) and length(8/10/12/14mm). The superstructures consist of Ball Cap. Ball Cap intended to retain the O-ring inside of the denture. The Prosthetics and Surgical Instruments provide the clinician to choose only those components required for each clinical situation. The Implants are gamma sterilized and intended to single use. And the others and non-gamma stereilized and have to be sterilized by user before using.
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 | 08800049273517 | GS1 |
Customer Contacts
- Phone
- 213-365-2875
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Ø2.5X10.0mm |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 30 Degrees Celsius