FDA UDI
In Commercial Distribution
🇺🇸 United States
KöR
DI: 00850362007021
·
Model: KöR Impression Tray Adhesive
·
EVOLVE DENTAL TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KöR
- Primary DI
- 00850362007021
- Version / Model
- KöR Impression Tray Adhesive
- Catalog Number
- 10-1008
- Company Name
- EVOLVE DENTAL TECHNOLOGIES, INC.
- Labeler DUNS
- 005479970
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-15
- Public Version
- 2
- Public Version Date
- 2020-09-22
- Public Version Status
- Update
- Public Device Record Key
- 6f9047b5-723a-4bc0-b3a4-50edc0fc360b
Device Description
KöR Impression Tray Adhesive is an adhesive developed specifically for durable adhesion of addition curing vinyl silicone impression materials to disposable impression trays and avoids lifting of the impression material from the tray when taking the impression out of the mouth.
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 |
|---|---|---|---|---|
| 16658 | Dental impression material adhesive | A liquid material specifically made to give adhesion of an impression material to the impression tray. 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 | 00850362007021 | GS1 |
Customer Contacts
- Phone
- 949 713-0909
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K992001 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 10 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 73 Degrees Fahrenheit