EndoREZ Points
- Primary DI
- 00883205020697
- Brand
- EndoREZ Points
- Company
- ULTRADENT PRODUCTS, INC.
- Model
- 1639
- Catalog number
- 1639
- Device description
- EndoRez Points 35 .06 Taper
- Published
- 2018-02-07
- 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
- true
Related Records
Contact Domains
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 |
|---|---|---|---|---|
| 00883205020697 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00883205020697 | 00883205020697 | 883205020697 | 0883205020697 |
GMDN Terms
| Term | Definition |
|---|---|
| Natural gutta-percha | A dental material made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. This material is softened by heat and inserted into the root canal, where it hardens as it cools. After application, this device cannot be reused. |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +1(801)572-4200 | customerservice@ultradent.com |
Regulatory Flags
- DUNS number
- 013369913
- Device count
- 1
- 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
- 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
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| 00883205044419 | Valo X | 6519-DU | 6519-DU | 2025-12-04 |
| 00883205044426 | Valo X | 6538-DU | 6538-DU | 2025-12-04 |
| 00883205044143 | Enamelast | 6895 | 6895 | 2025-11-14 |
| 00883205044150 | Enamelast | 6896 | 6896 | 2025-11-14 |
| 00883205044167 | Enamelast | 6897 | 6897 | 2025-11-14 |
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Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 06978880221102 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221119 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
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| 06978880221157 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
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| 06978880221225 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221232 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221249 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221256 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
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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 |
| 06978880221331 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221348 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221355 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221362 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 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 |