FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Obsidian
DI: D745701121OBP01481
·
Model: 70-1121-OBP0148
·
Prismatik Dentalcraft, Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
Basic Information
- Brand Name
- Obsidian
- Primary DI
- D745701121OBP01481
- Version / Model
- 70-1121-OBP0148
- Catalog Number
- 70-1121-OBP0148
- Company Name
- Prismatik Dentalcraft, Inc
- Labeler DUNS
- 022761689
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 7
- Public Version Date
- 2023-11-13
- Public Version Status
- Update
- Public Device Record Key
- 79513203-82cb-4361-8d66-f58bd75762a3
- Distribution End Date
- 2023-11-13
Device Description
Obsidian Press A2 15mm/8g/3 Ingots GD
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
- Yes
- 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 |
|---|---|---|---|---|
| EIH | POWDER, PORCELAIN | Dental | 872.6660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16187 | Dental appliance fabrication material, ceramic | A dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D745701121OBP01481 | HIBCC | ||||
| Unit of Use | D745701121OBP01480 | HIBCC |
Customer Contacts
- Phone
- +1(800)854-7256
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141887 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 8 | Gram |