FDA UDI
In Commercial Distribution
🇺🇸 United States
MASTER-DENT
DI: 00816526021791
·
Model: 20-329
·
DENTONICS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MASTER-DENT
- Primary DI
- 00816526021791
- Version / Model
- 20-329
- Company Name
- DENTONICS INC
- Labeler DUNS
- 186285342
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2023-10-27
- Public Version Status
- Update
- Public Device Record Key
- ab68be27-986d-4cb6-9742-0787e588d04c
Device Description
Vinyl Polysiloxane Cartridges, REGULAR Set, Heavy Body (4x50ml cart. only)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| 35860 | Dental impression material syringe, reusable | A non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into a patient's mouth. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816526021791 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K930248 | 000 |