ArgenPMMA 95x20-D2
- Primary DI
- D818116243
- Brand
- ArgenPMMA 95x20-D2
- Company
- ARGEN CORPORATION, THE
- Model
- 116243
- Catalog number
- 116243
- Device description
- Crown And Bridge, Temporary, Resin
- Published
- 2022-03-14
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| EBG | CROWN AND BRIDGE, TEMPORARY, RESIN |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EBG | Crown And Bridge, Temporary, Resin | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D818116243 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Dental acrylic resin | A non-sterile substance intended for professional use as a dental cement, luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, typically for short-term fixed prosthesis use (temporary crowns and bridges used for 6 months or less) or long-term removable prosthesis use. It consists of a self-, light-, or dual-curing acrylic resin material [e.g., polymethylmethacrylate (PMMA)]; it does not include any additional hardening fillers/components. It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused. |
Contacts
| Phone | Email |
|---|
| +1(858) 455-7900 | pcascone@argen.com |
Regulatory Flags
- DUNS number
- 103095543
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| D818137851 | ArgenZ GT 98x16 A3 | 137851 | 137851 | 2026-01-15 |
| D818137859 | ArgenZ GT 98x20 A1 | 137859 | 137859 | 2026-01-15 |
| D818137860 | ArgenZ GT 98x20 A2 | 137860 | 137860 | 2026-01-15 |
| D818137861 | ArgenZ GT 98x20 A3 | 137861 | 137861 | 2026-01-15 |
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| D818137865 | ArgenZ GT 98x25 A2 | 137865 | 137865 | 2026-01-15 |
| D818137866 | ArgenZ GT 98x25 A3 | 137866 | 137866 | 2026-01-15 |
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| D818137877 | ArgenZ GT 98x12 B4 | 137877 | 137877 | 2026-01-15 |
| D818137882 | ArgenZ GT 98x16 B1 | 137882 | 137882 | 2026-01-15 |
| D818137885 | ArgenZ GT 98x16 B4 | 137885 | 137885 | 2026-01-15 |
| D818137890 | ArgenZ GT 98x20 B1 | 137890 | 137890 | 2026-01-15 |
| D818137893 | ArgenZ GT 98x20 B4 | 137893 | 137893 | 2026-01-15 |
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