FDA UDI
In Commercial Distribution
🇺🇸 United States
BISICO Paste Hardener
DI: EBIB009501
·
Model: 00950
·
bisico Bielefelder Dentalsilicone GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BISICO Paste Hardener
- Primary DI
- EBIB009501
- Version / Model
- 00950
- Catalog Number
- 00950
- Company Name
- bisico Bielefelder Dentalsilicone GmbH & Co. KG
- Labeler DUNS
- 316133664
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-26
- Public Version
- 1
- Public Version Date
- 2020-07-06
- Public Version Status
- New
- Public Device Record Key
- e94207a8-5744-4f3c-9635-2cbed2b6b0dd
Device Description
Hardening paste (catalyst) for mixing with condensation-curing impression silicones (C-silicones). The product is used in dentistry and in the laboratory.
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- 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 |
|---|---|---|---|---|
| EBH | Material, Impression Tray, Resin | Dental | 872.3670 | 1 |
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 | EBIB009501 | HIBCC |
Customer Contacts
- Phone
- +495218016800
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius