Visalys CemCore Try In Paste
- Primary DI
- E217135921
- Brand
- Visalys CemCore Try In Paste
- Company
- Kettenbach GmbH & Co. KG
- Model
- 13592
- Catalog number
- 13592
- Device description
- Visalys CemCore Try In Paste Universal (A2/A3) 1 x 1,4 ml + 5 Application tips
- Published
- 2019-11-25
- Public version status
- Update
- Distribution status
- Not 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 |
|---|---|
| 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 |
|---|---|---|---|---|
| E217135921 | Primary | HIBCC | 0 |
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
- 316803246
- 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
- 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 |
|---|---|---|---|---|
| E217135901 | Visalys CemCore Try In Paste | 13590 | 13590 | 2019-11-25 |
| E217135911 | Visalys CemCore Try In Paste | 13591 | 13591 | 2019-11-25 |
| E217135931 | Visalys CemCore Try In Paste | 13593 | 13593 | 2019-11-25 |
| E217135941 | Visalys CemCore Try In Paste | 13594 | 13594 | 2019-11-25 |
| E217149401 | ProphyProtect | 14940 | 2026-06-08 | |
| E217119291 | Futar | 11929 | 11929 | 2026-04-02 |
| E217150601 | Visalys Bulk Fill | 15060 | 2026-03-05 | |
| E217150611 | Visalys Bulk Fill | 15061 | 2026-03-05 | |
| E217150621 | Visalys Bulk Fill | 15062 | 2026-03-05 | |
| E217150681 | Visalys Bulk | 15068 | 2026-03-05 | |
| E217150761 | Visalys BioCeramic Block | 15076 | 15076 | 2026-01-09 |
| E217150751 | Visalys BioCeramic Block | 15075 | 2026-01-19 | |
| E217150851 | Visalys BioCeramic Block | 15085 | 15085 | 2026-01-19 |
| E217150701 | Visalys BioCeramic Block | 15070 | 15070 | 2026-01-09 |
| E217150711 | Visalys BioCeramic Block | 15071 | 15071 | 2026-01-09 |
| E217150721 | Visalys BioCeramic Block | 15072 | 15072 | 2026-01-09 |
| E217150731 | Visalys BioCeramic Block | 15073 | 15073 | 2026-01-09 |
| E217150741 | Visalys BioCeramic Block | 15074 | 15074 | 2026-01-09 |
| E217150801 | Visalys BioCeramic Block | 15080 | 15080 | 2026-01-09 |
| E217150811 | Visalys BioCeramic Block | 15081 | 15081 | 2026-01-09 |
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