EsCom100 A3 Syringe
- Primary DI
- 08809262955231
- Brand
- EsCom100 A3 Syringe
- Company
- Spident Co., Ltd.
- Model
- 101-0703
- Catalog number
- 101-0703
- Device description
- Nano-hybrid universal composite resin for posterior and anterior restorations.
- Published
- 2017-02-20
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
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 |
|---|---|
| K110428 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00027202309144 | Package | GS1 | 60 | In Commercial Distribution |
| 00202201110070 | Package | GS1 | 280 | In Commercial Distribution |
| 08809262955231 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00027202309144 | 00027202309144 | 027202309144 | 0027202309144 |
| 00202201110070 | 00202201110070 | 202201110070 | 0202201110070 |
| 08809262955231 | 08809262955231 | 8809262955231 |
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. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 201-944-0511 | Spident.usa@gmail.com |
Regulatory Flags#
- DUNS number
- 689370711
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 08809262955514 | FineDam | FineDam x 4ea | 2026-10-07 | |
| 08809262954302 | Soft Prep | 101-1401 | 101-1401 | 2017-02-20 |
| 08809262950823 | OrthoFit | OrthoFit Bond mini | 2026-07-14 | |
| 08809262957983 | OrthoFit | OrthoFit Bond 2ea | 2026-07-14 | |
| 08809262957990 | OrthoFit | OrthoFit Splint | 2026-07-14 | |
| 08809262953602 | EsCem | EsCem A2 | 2026-04-29 | |
| 08809262953619 | EsCem | EsCem A3 | 2026-04-29 | |
| 08809262953626 | EsCem | EsCem TW | 2026-04-29 | |
| 08809262959000 | Temro.Flow | Temp it Flow+ yellow 4ea | 2026-04-28 | |
| 08809262959017 | Temro.Flow | Temp it Flow+ Blu 4ea | 2026-04-28 | |
| 08809262953206 | EsCom250 | EsCom250 A1 | #3203A1 | 2026-04-21 |
| 08809262953213 | EsCom250 | EsCom250 A2 | #3203A2 | 2026-04-21 |
| 08809262953220 | EsCom250 | EsCom250 A3 | #3203A3 | 2026-04-21 |
| 08809262953237 | EsCom250 | EsCom250 A3.5 | #3203A35 | 2026-04-21 |
| 08809262953244 | EsCom250 | EsCom250 A4 | #3203A4 | 2026-04-21 |
| 08809262953251 | EsCom250 | EsCom250 B1 | #3203B1 | 2026-04-21 |
| 08809262953268 | EsCom250 | EsCom250 B2 | #3203B2 | 2026-04-21 |
| 08809262953275 | EsCom250 | EsCom250 C2 | #3203C2 | 2026-04-21 |
| 08809262953282 | EsCom250 | EsCom250 D2 | #3203D2 | 2026-04-21 |
| 08809262953299 | EsCom250 | EsCom250 G1 | #3203G1 | 2026-04-21 |
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 |