FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Jazzy DC Acrylic Resin
DI: D820JAZ0
·
Model: Single Double-Barrel Syringe
·
DENALI CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Jazzy DC Acrylic Resin
- Primary DI
- D820JAZ0
- Version / Model
- Single Double-Barrel Syringe
- Catalog Number
- JAZ
- Company Name
- DENALI CORPORATION
- Labeler DUNS
- 191036107
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-09
- Public Version
- 3
- Public Version Date
- 2023-06-12
- Public Version Status
- Update
- Public Device Record Key
- 157f3fd5-9548-49f9-8e93-51be25cd8496
- Distribution End Date
- 2023-01-01
Device Description
Dual Cure Pattern, Modeling, and Indexing Resin.
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
- Yes
- 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 |
|---|---|---|---|---|
| EKO | Denture Preformed (Partially Prefabricated Denture) | Dental | 872.3600 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16727 | Dental prosthesis restorative material, unfilled resin | A material designed to repair dental prostheses that consists of an unfilled polymeric resin. The material works as a bonding agent to provide a strong and long-lasting attachment to the segments of a broken or cracked prosthesis; it typically consists of a single or two-component polymeric (e.g., acrylic) resin that usually becomes a solid polymer when treated with light and/or heat. The material is used in a dentist?s office or dental laboratory to repair fixed dental prostheses and/or partial or total dentures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D820JAZ0 | HIBCC |