FDA UDI
In Commercial Distribution
🇺🇸 United States
Alpha-Dent® Alginate Impression Material
DI: D73560301030010
·
Model: 603.0103.001
·
DENTAL TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Alpha-Dent® Alginate Impression Material
- Primary DI
- D73560301030010
- Version / Model
- 603.0103.001
- Catalog Number
- 603.0103.001
- Company Name
- DENTAL TECHNOLOGIES, INC.
- Labeler DUNS
- 148312838
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 9b5d6a04-7eb7-4b94-b5ef-fa5e5323e58f
Device Description
Alpha-Dent® Alginate Impression Material is available in a variety of flavors and set types. This heavy body material is designed to produce consistent impressions. Each can includes powder scoop and vial.
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
- No
- 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 |
|---|---|---|---|---|
| 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 | D73560301030010 | HIBCC |
Customer Contacts
- Phone
- 847-677-5500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K790595 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 22 – 25 Degrees Celsius