Jeltrate® Dustless Alginate Impression Material
- Primary DI
- D0026052241
- Brand
- Jeltrate® Dustless Alginate Impression Material
- Company
- DENTSPLY INTERNATIONAL INC.
- Model
- 605224
- Catalog number
- 605224
- Device description
- Jeltrate® Dustless Regular Set Pouch
- Published
- 2022-09-20
- 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
- false
Product Codes
| Code | Name |
|---|
| ELW | MATERIAL, IMPRESSION |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| ELW | Material, Impression | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D0026052241 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Alginate dental impression material | A material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is placed on an impression tray and inserted into the mouth. This is a single-use device. |
Contacts
| Phone | Email |
|---|
| +1(800)532-2855 | MilfordDE-Customer-Service@dentsplysirona.com |
Regulatory Flags
- DUNS number
- 083235549
- 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
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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| D0013011221 | Ceramco® 3 | Opaceous Dentin D3 | 301122 | 2016-09-21 |
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