UniFil® 000063
GUDID D0470000631
UniFil® 6 mL self-etching primer liquid
Gc America Inc.
Dentine bonding agent/set| Primary Device ID | D0470000631 |
| NIH Device Record Key | f3c89c84-498a-45e3-b1b5-26cea69aea61 |
| Commercial Distribution Discontinuation | 2019-03-15 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | UniFil® |
| Version Model Number | 000063 |
| Catalog Number | 000063 |
| Company DUNS | 005473608 |
| Company Name | Gc America Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Total Volume | 6 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D0470000631 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K013997
FDA Product Code
| KLE | AGENT, TOOTH BONDING, RESIN |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-02-16 |
| Device Publish Date | 2016-08-01 |
On-Brand Devices [UniFil®]
| D6584210011 | UniFil® UniFil Bond Starter Kit (1 x 6mL bottle of UniFil Bond Self-Etching Primer, 1 x 6mL bot |
| D0470000641 | UniFil® 6 mL bonding agent liquid |
| D0470000631 | UniFil® 6 mL self-etching primer liquid |
Trademark Results [UniFil]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 UNIFIL 77060215 3390786 Live/Registered |
MIDWEST FILTRATION LLC 2006-12-08 |
 UNIFIL 75498543 2516066 Live/Registered |
GC CORPORATION 1998-06-09 |
 UNIFIL 74518127 1934821 Dead/Cancelled |
Textiles Nacionales no Tejidos, S.A. deC.V. 1994-04-28 |
 UNIFIL 73767367 1671561 Dead/Cancelled |
IMPERIAL CHEMICAL INDUSTRIES PLC 1988-12-05 |
 UNIFIL 73707780 1567148 Dead/Cancelled |
MIDWEST FILTRATION COMPANY 1988-01-26 |
 UNIFIL 73413670 1285780 Dead/Cancelled |
Purdue Frederick Company, The 1983-02-15 |
 UNIFIL 73166567 1114914 Dead/Cancelled |
W.R. GRACE & CO. 1978-04-17 |
 UNIFIL 72155248 0753581 Dead/Expired |
HUMBLE OIL & REFINING COMPANY 1962-10-16 |
 UNIFIL 71649907 0587989 Live/Registered |
SCULLY SIGNAL COMPANY 1953-07-06 |
 UNIFIL 71634502 0578554 Dead/Expired |
UNIVERSAL WINDING COMPANY 1952-08-26 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.