Once-Fil Flow
- Primary DI
- 08809518340668
- Brand
- Once-Fil Flow
- Company
- MEDICLUS CO.,LTD
- Model
- 101-2
- Catalog number
- EC2501001
- Device description
- Once-Fil Flow is a light-curing temporary filling material. Yellow shade.
- Published
- 2026-05-28
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
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 |
|---|---|
| K251283 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08809518340668 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08809518340668 | 08809518340668 | 8809518340668 |
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. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Total Volume | 0 |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 0 | 0 |
Regulatory Flags#
- DUNS number
- 688304449
- 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
- true
- 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 |
|---|---|---|---|---|
| 08809518346677 | CanalPro CalciSeal | 65003227 | 65003227 | 2026-09-22 |
| 08809518345663 | One-Temp Flow | 104-1 | EC2501001 | 2026-08-12 |
| 08809518345670 | One-Temp Flow | 104-2 | EC2501001 | 2026-08-12 |
| 08809518346721 | Disposable Tip | 65003225 | 2026-06-05 | |
| 08809518341511 | Any-Paste | 505-1 | EC2501001 | 2026-06-01 |
| 08809518342105 | Hi-Bond Universal | 303-2 | EC2501001 | 2026-06-01 |
| 08809518340651 | Once-Fil Flow | 101-1 | EC2501001 | 2026-05-28 |
| 08809518344994 | Any-Com Bulk | 307-11 Any-Com Bulk A1 | EC2501001 | 2026-05-21 |
| 08809518345007 | Any-Com Bulk | 307-12 Any-Com Bulk A2 | EC2501001 | 2026-05-21 |
| 08809518345014 | Any-Com Bulk | 307-13 Any-Com Bulk A3 | EC2501001 | 2026-05-21 |
| 08809518345021 | Any-Com Bulk | 307-14 Any-Com Bulk Blue | EC2501001 | 2026-05-21 |
| 08809518345038 | Any-Com Bulk | 307-15 Any-Com Bulk TL | EC2501001 | 2026-05-21 |
| 08809518345106 | One-Fil Putty Injectable | 509-1 One-Fil Putty Injectable | EC2501001 | 2026-05-21 |
| 08809518341252 | One-Fil | 508-1 One-Fil | EC2501001 | 2026-05-11 |
| 08809518343706 | One-Fil Putty | 509-2 One-Fil Putty | EC2501001 | 2026-05-11 |
| 08809518346608 | CanalPro CalciSeal | 60043033 | 60043033 | 2026-04-23 |
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|---|---|---|---|---|
| 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 |
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| 06970006746605 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. | EBF | 2026-10-25 |
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| 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 |
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