FDA UDI
In Commercial Distribution
🇺🇸 United States
DiamoDent
DI: D907A12000
·
Model: N/A
·
DIAMODENT INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DiamoDent
- Primary DI
- D907A12000
- Version / Model
- N/A
- Catalog Number
- A1200
- Company Name
- DIAMODENT INC
- Labeler DUNS
- 013827410
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-29
- Public Version
- 1
- Public Version Date
- 2020-07-07
- Public Version Status
- New
- Public Device Record Key
- c40e4086-627e-44a3-9262-e48e45ec32cf
Device Description
Scan Body, Medical Grade PEEK & Titanium Compatible with: - 3.75 & 4mm Regular Platform (RP) Branemark implants -3.75 & 4mm Standard BIOMET 3i implants -3.8 & 4.5mm HL Steri-Oss implants
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Dry Heat Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | Dental | 872.3640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46122 | Dental implant suprastructure, temporary, preformed, reusable | A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes fixture impression pick-ups and replica devices and is available in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a reusable device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D907A12000 | HIBCC |