FDA UDI
In Commercial Distribution
🇺🇸 United States
Pure PMMA Disc
DI: 04806532673035
·
Model: Shade: BL4, Thickness: 27mm
·
QUEST DENTAL MATERIAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pure PMMA Disc
- Primary DI
- 04806532673035
- Version / Model
- Shade: BL4, Thickness: 27mm
- Catalog Number
- 303
- Company Name
- QUEST DENTAL MATERIAL CORPORATION
- Labeler DUNS
- 721541530
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-12-27
- Public Version
- 4
- Public Version Date
- 2021-10-29
- Public Version Status
- Update
- Public Device Record Key
- 91ea6eb5-a049-4b9e-9e84-bd6a4b37cb40
Device Description
Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crowns and bridges in various CAD/CAM systems until permanent restorations can be delivered. Restorations are designed and manufactured by dental professionals and technicians using open CAD/CAM technology.
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
- 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
- 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 |
|---|---|---|---|---|
| 31783 | Temporary dental crown/bridge | A prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04806532673035 | GS1 |
Customer Contacts
- Phone
- 949-870-3895
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172281 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Thickness: 27mm | ||
| Outer Diameter | 98 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room temperature, avoid direct sunlight