FDA UDI
In Commercial Distribution
🇺🇸 United States
Neodent
DI: 07899878029359
·
Model: 114.793
·
JJGC Indústria e Comércio de Materiais Dentários S/A.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Neodent
- Primary DI
- 07899878029359
- Version / Model
- 114.793
- Catalog Number
- 114.793
- Company Name
- JJGC Indústria e Comércio de Materiais Dentários S/A.
- Labeler DUNS
- 906713888
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-13
- Public Version
- 2
- Public Version Date
- 2023-12-21
- Public Version Status
- Update
- Public Device Record Key
- 0d77805a-5522-435a-8bab-f20eb2a1c254
Device Description
GM ABUTMENT TRY-IN 30
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|
| 64355 | Dental implant abutment trial | A copy of a dental implant abutment intended to be used intraorally during dental implant restorative procedures to reproduce the characteristics of an abutment (e.g., angle, diameter, transmucosal or cementable area height) to facilitate selection of an appropriate final prosthetic abutment. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07899878029359 | GS1 |
Customer Contacts
- Phone
- +1(855)412-8883
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 6 | Millimeter | |
| Outer Diameter | 4.5 | Millimeter | |
| Height | 1.5 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 40 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from Sunlight