edelweiss OCCLUSION SET 17-27 M up
- Primary DI
- 09120046322018
- Brand
- edelweiss OCCLUSION SET 17-27 M up
- Company
- edelweiss dentistry products gmbh
- Model
- 13175
- Device description
- SET of total 8 pcs OCCLUSIONS (1x edelweiss OCCLUSION 17 M, 1x edelweiss OCCLUSION 16 M, 1x edelweiss OCCLUSION 15 M, 1x edelweiss OCCLUSION 14 M, 1x edelweiss OCCLUSION 24 M, 1x edelweiss OCCLUSION 25 M, 1x edelweiss OCCLUSION 26 M, 1x edelweiss OCCLUSION 27 M)
- Published
- 2018-05-09
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- 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 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 09120046322018 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 09120046322018 | 09120046322018 | 9120046322018 |
GMDN Terms
| Term | Definition |
|---|
| Dental composite resin | A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused. |
Regulatory Flags
- DUNS number
- 300537672
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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 |
| 09120046322568 | edelweiss CAD/CAM C-BLOCK A2 (10/12/16) | 21103 | | 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 |
Other Devices Sharing Product Codes
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|---|
| 00815967025856 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-24 |
| 00815967025863 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-24 |
| 00815967025870 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-24 |
| 00815967021438 | OptiComp | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967021797 | OptiComp | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967027447 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028161 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028178 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028185 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028192 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028208 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028215 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028222 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028239 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028246 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028253 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028260 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028277 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028284 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028291 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028307 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028314 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028321 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028338 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028345 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028352 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028369 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028376 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028383 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028390 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |