edelweiss CAD/CAM C-BLOCK A2 (10/12/16)
- Primary DI
- 09120046322568
- Brand
- edelweiss CAD/CAM C-BLOCK A2 (10/12/16)
- Company
- edelweiss dentistry products gmbh
- Model
- 21103
- Device description
- 5pcs edelweiss CAD/CAM C-BLOCK A2 (10/12/16)
- Published
- 2024-11-04
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| EBF | Material, Tooth Shade, Resin |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | Dental | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K241131 | 000 |
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| K241131 | 000 | edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK | Edelweiss Dentistry Products GmbH | 2024-10-18 | EBF |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 09120046322568 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 09120046322568 | 09120046322568 | 9120046322568 |
GMDN Terms#
| Term | Definition |
|---|---|
| Dental appliance fabrication material, combination-material | A dental material made of a combination of metal, ceramic, and/or synthetic polymer [e.g., polyethylene (PE)] 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. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 300537672
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 09120046322414 | edelweiss CAD/CAM T-BLOCK Universal Enamel (12/14/18) | 19100 | 2024-11-04 | |
| 09120046322421 | edelweiss CAD/CAM C-BLOCK A0 (12/14/18) | 19101 | 2024-11-04 | |
| 09120046322438 | edelweiss CAD/CAM C-BLOCK A1 (12/14/18) | 19102 | 2024-11-04 | |
| 09120046322445 | edelweiss CAD/CAM C-BLOCK A2 (12/14/18) | 19103 | 2024-11-04 | |
| 09120046322452 | edelweiss CAD/CAM C-BLOCK A3 (12/14/18) | 19104 | 2024-11-04 | |
| 09120046322476 | edelweiss CAD/CAM i-BLOCK (ØS) Universal Enamel | 19100.A | 2024-11-04 | |
| 09120046322483 | edelweiss CAD/CAM i-BLOCK (ØS) A0 | 19101.A | 2024-11-04 | |
| 09120046322490 | edelweiss CAD/CAM i-BLOCK (ØS) A1 | 19102.A | 2024-11-04 | |
| 09120046322506 | edelweiss CAD/CAM i-BLOCK (ØS) A2 | 19103.A | 2024-11-04 | |
| 09120046322513 | edelweiss CAD/CAM i-BLOCK (ØS) A3 | 19104.A | 2024-11-04 | |
| 09120046322537 | edelweiss CAD/CAM T-BLOCK Universal Enamel (10/12/16) | 21100 | 2024-11-04 | |
| 09120046322544 | edelweiss CAD/CAM C-BLOCK A0 (10/12/16) | 21101 | 2024-11-04 | |
| 09120046322551 | edelweiss CAD/CAM C-BLOCK A1 (10/12/16) | 21102 | 2024-11-04 | |
| 09120046322575 | edelweiss CAD/CAM C-BLOCK A3 (10/12/16) | 21104 | 2024-11-04 | |
| 09120046325132 | edelweiss CAD/CAM i-BLOCK (ØL) Universal Enamel | 19100.A.L | 2024-11-04 | |
| 09120046325149 | edelweiss CAD/CAM i-BLOCK (ØL) A0 | 19101.A.L | 2024-11-04 | |
| 09120046325156 | edelweiss CAD/CAM i-BLOCK (ØL) A1 | 19102.A.L | 2024-11-04 | |
| 09120046325163 | edelweiss CAD/CAM i-BLOCK (ØL) A2 | 19103.A.L | 2024-11-04 | |
| 09120046325170 | edelweiss CAD/CAM i-BLOCK (ØL) A3 | 19104.A.L | 2024-11-04 | |
| 09120046326610 | Ceramir CAD/CAM T-BLOCK Universal Enamel | 805187 | 2024-11-04 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 06970006745677 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746575 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746582 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746599 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746605 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746612 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746629 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746636 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746643 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746650 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746667 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746674 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746681 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746698 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746704 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746711 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746728 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746735 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746742 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746759 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746766 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746773 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746780 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746797 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746803 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746810 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06970006746827 | Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06972220489016 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06972220489023 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
| 06972220489047 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |