OptiBond FL 33352
GUDID 10841396105279
50-Pack Unidose Pouches
Kerr Corporation
Dentine bonding agent/set| Primary Device ID | 10841396105279 |
| NIH Device Record Key | 16c22d0e-1d71-4d1f-baa2-5ff2b00f9031 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OptiBond FL |
| Version Model Number | 33352 |
| Catalog Number | 33352 |
| Company DUNS | 199354556 |
| Company Name | Kerr Corporation |
| Device Count | 50 |
| 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 | true |
| 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 | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
| Total Volume | 18 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841396105272 [Unit of Use] |
| GS1 | 10841396105279 [Primary] |
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 | 3 |
| Public Version Date | 2021-12-10 |
| Device Publish Date | 2016-08-01 |
On-Brand Devices [OptiBond FL]
| 00841396108112 | Filled Light-Cure Bonding Agent; Bottle Kit |
| 00841396105296 | Adhesive |
| 00841396105289 | Prime |
| 10841396105279 | 50-Pack Unidose Pouches |
Trademark Results [OptiBond FL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPTIBOND FL 74666789 1962023 Live/Registered |
Kerr Corporation 1995-04-28 |
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