SCOTT'S VPS PUTTY 2-JARS REG SET
Basic Information
- Brand Name
- SCOTT'S VPS PUTTY 2-JARS REG SET
- Primary DI
- D77810480060
- Version / Model
- 104-8006
- Catalog Number
- 104-8006
- Company Name
- SCOTT'S DENTAL SUPPLY L.L.C.
- Labeler DUNS
- 137217043
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-02
- Public Version
- 4
- Public Version Date
- 2020-08-26
- Public Version Status
- Update
- Public Device Record Key
- ce5910a3-7d3f-4d03-850c-f85bc47163ed
Device Description
Hydroclone VPS addition cured silicone elastomeric impression material (VPS) meets or exceeds requirements for Type 1 impression materials specified by the American Dental Association Specification No. 19. Products are available in multiple viscosities (and as a putty) in both tubes and cartridges for use in various impression techniques. Hydroclone VPS is manufactured to preform according to specifications for work and set time at 73°F (23°C). Higher temperatures will decrease the work time and set time. Conversely, lower temperatures will extend work/set times. The shelf life of these materials is two years. During hot weather this material can be refrigerated to prevent degradation – but should be warmed to room temperature before use. Delivery method: two part putty, regular set, unflavored.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | D77810480060 | HIBCC |
Customer Contacts
- Phone
- +1(800)901-3368
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 600 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 73 Degrees Fahrenheit