FDA UDI
In Commercial Distribution
🇺🇸 United States
Jeltrate® Alginate Impression Material
DI: D0026080580
·
Model: 608058
·
DENTSPLY INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Jeltrate® Alginate Impression Material
- Primary DI
- D0026080580
- Version / Model
- 608058
- Catalog Number
- 608058
- Company Name
- DENTSPLY INTERNATIONAL INC.
- Labeler DUNS
- 083235549
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- bc69a687-ce54-48e1-9d06-66550af72cc7
Device Description
Jeltrate® Alginate Impression Material, Regular Set, 22 lbs Bulk
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ELW | MATERIAL, IMPRESSION | Dental | 872.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35863 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D0026080580 | HIBCC |
Customer Contacts
- Phone
- +1(800)532-2855
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 10 | Kilogram | |
| Device Size Text, specify | 22 lb (10 Kilo) bulk package Regular Set |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 29 Degrees Celsius