ProShape One Gutta Percha Small
- Primary DI
- 10810138822255
- Brand
- ProShape One Gutta Percha Small
- Company
- Endo Direct LLC
- Model
- SDGP25061
- Published
- 2023-07-15
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| EKM | Gutta-Percha |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| EKM | Gutta-Percha | Dental | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10810138822255 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10810138822255 | 10810138822255 |
GMDN Terms#
| Term | Definition |
|---|---|
| Synthetic gutta-percha | A dental material made from a polymer-based, synthetic gutta-percha containing fillers and radiopacifiers in a soft resin matrix, intended to fill the root canal of a tooth. This material has the ability to resist leakage significantly better than natural gutta-percha based obturation whilst strengthening the root resulting in roots having a coronal and apical seal as part of the canal filling process. After application, this device cannot be reused. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 125216703
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10810138823450 | ProShape Cyclone 60/06 25mm | PS600625 | 2026-05-11 | |
| 10810138823429 | ProShape Cyclone KD File, 55/06, 21mm | Sample | PS550621 | 2026-04-13 |
| 10810138823436 | ProShape Cyclone KD File, 60/06, 21mm | Sample | PS600621 | 2026-04-13 |
| 10810138823443 | ProShape Cyclone KD File, 55/06, 25mm | Sample | PS550625 | 2026-04-13 |
| 10810138823382 | ProShape HT-Assorted Pack | Sample | 2026-03-16 | |
| 10810138823399 | ProShape One Assorted Pack | Sample | 2026-03-16 | |
| 10810138823405 | Proshape Cyclone Asst Pack | Sample | 2026-03-16 | |
| 10810138823412 | Proshape Conserve Asst Pack | Sample | 2026-03-16 | |
| 10810138823276 | RC Mix | EDRCMIX | 2025-03-03 | |
| 10810138823269 | ProShape Orifice Barrier | PSOS17 | 2025-01-13 | |
| 10810138823245 | ProShape Path Size 13 21mm | PSPATH21 | 2024-11-14 | |
| 10810138823252 | ProShape Path Size 13 25mm | PSPATH25 | 2024-11-14 | |
| 10810138822262 | ProShape One Gutta Percha Primary | SDGP30061 | 2023-07-15 | |
| 10810138822279 | ProShape One Gutta Percha Medium | SDGP35061 | 2023-07-15 | |
| 10810138822286 | ProShape One Gutta Percha Large | SDGP40061 | 2023-07-15 | |
| 10810138822293 | ProShape One Paper Points Small | SDGP45061 | 2023-07-15 | |
| 10810138822309 | ProShape One Paper Points Primary | SDGP50061 | 2023-07-15 | |
| 10810138822316 | ProShape One Paper Points Medium | SDPP2004 | 2023-07-15 | |
| 10810138822323 | ProShape One Paper Points Large | SDPP2504 | 2023-07-15 | |
| 10810138822330 | ProShape Gutta Percha ISO 20.04 | SDPP3004 | 2023-07-15 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00810213814697 | EdgeEndo® EdgeCore™ for EdgeTaper™ | HSG-S Corp. | EKM | 2026-08-19 |
| 00810213814703 | EdgeEndo® EdgeCore™ for EdgeTaper™ | HSG-S Corp. | EKM | 2026-08-19 |
| 00810213814710 | EdgeEndo® EdgeCore™ for EdgeTaper™ | HSG-S Corp. | EKM | 2026-08-19 |
| 00810213814727 | EdgeEndo® EdgeCore™ for EdgeTaper™ | HSG-S Corp. | EKM | 2026-08-19 |
| 00810213814741 | EdgeEndo® EdgeFill™ for EdgeTaper™ | HSG-S Corp. | EKM | 2026-08-19 |
| 00810213814758 | EdgeEndo® EdgeFill™ for EdgeTaper™ | HSG-S Corp. | EKM | 2026-08-19 |
| 00810213814765 | EdgeEndo® EdgeFill™ for EdgeTaper™ | HSG-S Corp. | EKM | 2026-08-19 |
| 00810213814789 | EdgeEndo® EdgeFill™ for EdgeTaper™ | HSG-S Corp. | EKM | 2026-08-19 |
| 00810213814864 | EdgeEndo® EdgeCore™ for EdgeOne™ | HSG-S Corp. | EKM | 2026-08-19 |
| 00810213814871 | EdgeEndo® EdgeCore™ for EdgeOne™ | HSG-S Corp. | EKM | 2026-08-19 |
| 00810213814895 | EdgeEndo® EdgeCore™ for EdgeOne™ | HSG-S Corp. | EKM | 2026-08-19 |
| 00810213814901 | EdgeEndo® EdgeFill™ for EdgeOne™ | HSG-S Corp. | EKM | 2026-08-19 |
| 00810213814918 | EdgeEndo® EdgeFill™ for EdgeOne™ | HSG-S Corp. | EKM | 2026-08-19 |
| 00810213814932 | EdgeEndo® EdgeFill™ for EdgeOne™ | HSG-S Corp. | EKM | 2026-08-19 |
| 00810213814963 | EdgeEndo® EdgeCore™ for EdgeEndo® | HSG-S Corp. | EKM | 2026-08-19 |
| 00810213814970 | EdgeEndo® EdgeCore™ for EdgeEndo® | HSG-S Corp. | EKM | 2026-08-19 |
| 00810213815014 | EdgeEndo® EdgeFill™ for EdgeEndo® | HSG-S Corp. | EKM | 2026-08-19 |
| 00810213815045 | EdgeEndo® EdgeFill™ for EdgeEndo® | HSG-S Corp. | EKM | 2026-08-19 |
| 00810213815052 | EdgeEndo® EdgeFill™ for EdgeEndo® | HSG-S Corp. | EKM | 2026-08-19 |
| 00810213815106 | EdgeEndo® EdgeCore™ for EdgeEndo® | HSG-S Corp. | EKM | 2026-08-19 |
| 00810213815120 | EdgeEndo® EdgeCore™ for EdgeEndo® | HSG-S Corp. | EKM | 2026-08-19 |
| 00810213815168 | EdgeEndo® EdgeFill™ for EdgeEndo® | HSG-S Corp. | EKM | 2026-08-19 |
| 00810213814734 | EdgeEndo® EdgeCore™ for EdgeTaper™ | HSG-S Corp. | EKM | 2026-08-18 |
| 00810213814772 | EdgeEndo® EdgeFill™ for EdgeTaper™ | HSG-S Corp. | EKM | 2026-08-18 |
| 00810213814888 | EdgeEndo® EdgeCore™ for EdgeOne™ | HSG-S Corp. | EKM | 2026-08-18 |
| 00810213814925 | EdgeEndo® EdgeFill™ for EdgeOne™ | HSG-S Corp. | EKM | 2026-08-18 |
| 00810213814949 | EdgeEndo® EdgeCore™ for EdgeEndo® | HSG-S Corp. | EKM | 2026-08-18 |
| 00810213814956 | EdgeEndo® EdgeCore™ for EdgeEndo® | HSG-S Corp. | EKM | 2026-08-18 |
| 00810213814987 | EdgeEndo® EdgeCore™ for EdgeEndo® | HSG-S Corp. | EKM | 2026-08-18 |
| 00810213814994 | EdgeEndo® EdgeCore™ for EdgeEndo® | HSG-S Corp. | EKM | 2026-08-18 |