3D Endo
- Primary DI
- 00810126503589
- Brand
- 3D Endo
- Company
- 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
- Model
- 3D-PPB20
- Catalog number
- 3D-PPB20
- Device description
- Absorbent Paper Points Box/200 #20
- Published
- 2023-03-01
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| EKN | Point, Paper, Endodontic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| EKN | Point, Paper, Endodontic | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00810126503589 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00810126503589 | 00810126503589 | 810126503589 | 0810126503589 |
GMDN Terms
| Term | Definition |
|---|---|
| Endodontic paper point | A non-medicated absorbent point used in endodontic procedures that has been sterilized once in a manner approved by the manufacturer. This is a single-use device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 080194935
- 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
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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|---|---|---|---|---|
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| 00810126508171 | 3D Dental | JSM-CW | 2026-03-16 | |
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| 00810126508201 | Essentials By 3D Dental | PTC-Y | 2026-03-12 | |
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| 00810126508218 | Essentials By 3D Dental | PBBT-100 | 2026-03-11 | |
| 00810126508225 | Essentials By 3D Dental | PBBT-20 | 2026-03-11 | |
| 00810126508232 | Basik by 3D Dental | BPGC345T | 2026-03-11 | |
| 00810126508249 | Basik by 3D Dental | BPGC316T | 2026-03-11 | |
| 00810126508256 | Basik by 3D Dental | BPGC304T | 2026-03-11 | |
| 00810126508263 | Basik by 3D Dental | BPGC303T | 2026-03-11 |
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|---|---|---|---|---|
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