FDA UDI
In Commercial Distribution
🇺🇸 United States
Top Quality Manufacturing VPS Impression Material
DI: TQ26126121261
·
Model: 12612126
·
TOP QUALITY MANUFACTURING, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- Top Quality Manufacturing VPS Impression Material
- Primary DI
- TQ26126121261
- Version / Model
- 12612126
- Catalog Number
- 12612126
- Company Name
- TOP QUALITY MANUFACTURING, INC.
- Labeler DUNS
- 113630649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2021-01-05
- Public Version
- 1
- Public Version Date
- 2021-01-13
- Public Version Status
- New
- Public Device Record Key
- 2a1f8403-eaf0-4b17-9b31-4d537c320a16
Device Description
Vinyl Polysiloxane Impression Material Medium Body - Regular Set
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 | TQ26126121260 | HIBCC | ||||
| Primary | TQ26126121261 | HIBCC |