Henry Schein
- Primary DI
- 00304040141380
- Brand
- Henry Schein
- Company
- HENRY SCHEIN, INC.
- Model
- 1049720
- Catalog number
- 1049720
- Device description
- Maxima Tapered GPPTS CC.04
- Published
- 2021-01-28
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
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 |
|---|---|---|---|---|
| 10304040141387 | Primary | GS1 | 0 | |
| 00304040141380 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10304040141387 | 10304040141387 | ||
| 00304040141380 | 00304040141380 | 304040141380 | 0304040141380 |
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
- 012430880
- Device count
- 100
- DM exempt
- false
- Premarket exempt
- true
- 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
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|---|---|---|---|---|
| 00304040195437 | Henry Schein | 5705824 | 5705824 | 2026-03-17 |
| 00304040195444 | Henry Schein | 5705825 | 5705825 | 2026-03-17 |
| 00304040195420 | Henry Schein | 5705823 | 5705823 | 2026-03-13 |
| 00304040187463 | Zirlux | 9200046 | 9200046 | 2026-02-04 |
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| 00304040187517 | Zirlux | 9200051 | 9200051 | 2026-02-04 |
| 00304040187524 | Zirlux | 9200052 | 9200052 | 2026-02-04 |
| 00304040187531 | Zirlux | 9200053 | 9200053 | 2026-02-04 |
| 00304040187548 | Zirlux | 9200054 | 9200054 | 2026-02-04 |
| 00304040187555 | Zirlux | 9200055 | 9200055 | 2026-02-04 |
| 00304040187562 | Zirlux | 9200056 | 9200056 | 2026-02-04 |
| 00304040187579 | Zirlux | 9200057 | 9200057 | 2026-02-04 |
| 00304040187586 | Zirlux | 9200058 | 9200058 | 2026-02-04 |
| 00304040187593 | Zirlux | 9200059 | 9200059 | 2026-02-04 |
| 00304040187616 | Zirlux | 9200061 | 9200061 | 2026-02-04 |
| 00304040187623 | Zirlux | 9200062 | 9200062 | 2026-02-04 |
| 00304040187647 | Zirlux | 9200063 | 9200063 | 2026-02-04 |
| 00304040187654 | Zirlux | 9200064 | 9200064 | 2026-02-04 |
| 00304040187661 | Zirlux | 9200065 | 9200065 | 2026-02-04 |
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| 06978880221294 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221300 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221317 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221324 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
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| 06978880221348 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
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| 06978880221379 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221386 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221393 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |