FDA UDI
In Commercial Distribution
🇺🇸 United States
EdgeTemp Hydraulic Temporary Restorative
DI: 00818365020027
·
Model: EETEMP
·
EDGE ENDO LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EdgeTemp Hydraulic Temporary Restorative
- Primary DI
- 00818365020027
- Version / Model
- EETEMP
- Company Name
- EDGE ENDO LLC
- Labeler DUNS
- 078474365
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-25
- Public Version
- 3
- Public Version Date
- 2021-10-29
- Public Version Status
- Update
- Public Device Record Key
- 4eb7b0dd-0165-4908-bc30-7bda51c15143
Device Description
For fabrication of temporary fillings and other temporary prosthetics for use until the permanent prosthetic is ready for installation. Intended to restore carious lesions or structural defects in teeth temporarily. Intended for use in cavities Classes I, II, III, IV (inlays and onlays) and as a restorative material for veneers, crowns and bridges.
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | Dental | 872.3770 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45236 | Temporary dental crown/bridge resin | A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00818365020027 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 40 | Gram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 25 Degrees Celsius