FDA UDI
In Commercial Distribution
🇺🇸 United States
Neodent
DI: 07899878064695
·
Model: 125.210
·
JJGC Indústria e Comércio de Materiais Dentários S/A.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Neodent
- Primary DI
- 07899878064695
- Version / Model
- 125.210
- Catalog Number
- 125.210
- 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
- 2024-05-07
- Public Version
- 1
- Public Version Date
- 2024-05-15
- Public Version Status
- New
- Public Device Record Key
- f9e2ca1d-5923-46c9-8d0a-bb3be7e8c3ae
Device Description
ZI PALATAL SETTER
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
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 46552 | Dental implantation drilling template retention pin | A small, metal peg designed to provide initial stability to anchor a custom-made surgical template that is fitted over the ridge of existing teeth and/or gum of a patient during the first stage of a dental implantation procedure. It is inserted through lateral guide hole(s) in the template, and is pressed into pre-drilled hole(s) in the jawbone. It is used for implantation procedures where a tooth/teeth are missing and a template is used to provide the dentist with the correct drilling position(s) for the implant(s). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07899878064695 | GS1 |
Customer Contacts
- Phone
- +1(855)412-8883
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 21.5 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight