FDA UDI
In Commercial Distribution
🇺🇸 United States
Algin-X™ Ultra Alginate Alternative
DI: D00261E8011
·
Model: 61E801
·
DENTSPLY INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
24
Basic Information
- Brand Name
- Algin-X™ Ultra Alginate Alternative
- Primary DI
- D00261E8011
- Version / Model
- 61E801
- Catalog Number
- 61E801
- Company Name
- DENTSPLY INTERNATIONAL INC.
- Labeler DUNS
- 083235549
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 24
- Record Status
- Published
- Publish Date
- 2022-04-20
- Public Version
- 1
- Public Version Date
- 2022-04-28
- Public Version Status
- New
- Public Device Record Key
- 4408c5ac-dd3a-44dd-9a73-269975870f88
Device Description
Algin-X™ Ultra Cartridge Bulk Refill
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| 35866 | Silicone dental impression material | An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being 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 |
|---|---|---|---|---|---|---|
| Unit of Use | D00261E8010 | HIBCC | ||||
| Primary | D00261E8011 | HIBCC |
Customer Contacts
- Phone
- +1(800)532-2855
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Use product at room temperature.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze. Protect from moisture.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Allow sufficient warm-up time if product was stored in a refrigerator.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Refrigerated storage is acceptable when not in use.
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 24 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use after expiration date.