FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Acrylic Block
DI: 14560227799116
·
Model: MCL-013-M
·
SUN MEDICAL CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
Basic Information
- Brand Name
- Acrylic Block
- Primary DI
- 14560227799116
- Version / Model
- MCL-013-M
- Catalog Number
- TS33US
- Company Name
- SUN MEDICAL CO.,LTD.
- Labeler DUNS
- 690922612
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-11-07
- Public Version
- 4
- Public Version Date
- 2019-08-02
- Public Version Status
- Update
- Public Device Record Key
- 884f657b-d889-45e0-9678-5b258568e28e
- Distribution End Date
- 2018-05-01
Device Description
Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is 232 mm length x 192 mm width x 35 mm depth, and the color type is Dark Pink.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | 872.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58288 | Dental appliance fabrication material, thermoplastic | A thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 14560227799116 | GS1 | ||||
| Unit of Use | 04560227799119 | GS1 | ||||
| Package | 24560227799113 | GS1 | Cardboard | 1 | Not in Commercial Distribution | 2018-05-01 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Depth | 35 | Millimeter | |
| Width | 192 | Millimeter | |
| Length | 232 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 30 Degrees Celsius