FDA UDI
In Commercial Distribution
🇺🇸 United States
VISCOGEL
DI: D010616050021
·
Model: 61605002
·
Dentsply De Trey GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VISCOGEL
- Primary DI
- D010616050021
- Version / Model
- 61605002
- Catalog Number
- 61605002
- Company Name
- Dentsply De Trey GmbH
- Labeler DUNS
- 315471722
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 806c6f3d-e4cc-47fd-9617-ab7ee8c1a83a
Device Description
VISCO GEL Standard Pack is a self-curing, resilient methacrylate formulation, intended for use as a limited-term soft linig material for complet and partial dentures. Visco-gel is received in 2 components powder (D010K2006000) and liquid (D010K3006010) both of them in a bottle delivery. With an additional bottle of a separator (D010K3006020) and its supporting accessories (Mixing Bowl, Powder Measure and Liquid Measure) it can be classified as a convenience kit.
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
- Yes
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | Dental | 872.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17610 | Denture reliner, soft, professional | A denture relining material used in dentistry by a dentist or dental laboratory technician that is applied as a permanent coating or lining on the base or tissue-contacting surface of a denture and which sets to a soft, plastic condition. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D010616050021 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 120 | Gram | |
| Device Size Text, specify | Liquid | ||
| Total Volume | 15 | Milliliter | |
| Total Volume | 90 | Milliliter | |
| Device Size Text, specify | Powder |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 24 Degrees Celsius