FDA UDI
In Commercial Distribution
🇺🇸 United States
UltraSil Putty 1000
DI: D95600USP1000
·
Model: US-P1000
·
D.S.I DENTAL SOLUTIONS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- UltraSil Putty 1000
- Primary DI
- D95600USP1000
- Version / Model
- US-P1000
- Company Name
- D.S.I DENTAL SOLUTIONS LTD
- Labeler DUNS
- 532290720
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-26
- Public Version
- 2
- Public Version Date
- 2025-02-17
- Public Version Status
- Update
- Public Device Record Key
- 97480b2f-8d2e-4b00-8658-c1ca2be50dd9
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 |
|---|---|---|---|---|
| 34799 | Composite dental impression material | A thermoplastic material designed 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. It is composed of a mixture of natural resins, fillers, and lubricants. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D95600USP1000 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222741 | 000 |