FibreKleer 4x
GUDID 00814978022335
Fiber Post; 1.375 mm Tapered Drill
Kerr Corporation
Fluted surgical drill bit, reusable| Primary Device ID | 00814978022335 |
| NIH Device Record Key | cfec13ad-a780-45b2-b9c0-3bad0de57675 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FibreKleer 4x |
| Version Model Number | N81CB |
| Company DUNS | 199354556 |
| Company Name | Kerr Corporation |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | false |
| 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
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
| Outer Diameter | 1.375 Millimeter |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814978022335 [Primary] |
FDA Product Code
| EJL | BUR, DENTAL |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
[00814978022335]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-11-22 |
| Device Publish Date | 2016-08-01 |
On-Brand Devices [FibreKleer 4x]
| 00814978022342 | Fiber Post; 1.50 mm Tapered Drill |
| 00814978022335 | Fiber Post; 1.375 mm Tapered Drill |
| 00814978022328 | Fiber Post; 1.25 mm Tapered Drill |
| 10814978023339 | Fiber Reinforced Post; Shape - Original; Trial Kit; 5 x 1.25 mm Posts, 1 x 1.25 mm Drill |
| 10814978023322 | Fiber Post Shape Original 5x 1.00 mm 1.25 mm 1.50 mm Posts; 1x 1.00 mm, 1.25 mm, 1.50 mm Drills |
| 10814978023315 | Fiber Reinforced Post; Shape - Tapered; Trial Kit; 5 x 1.25 mm Posts, 1 x 1.25 mm Drill |
| 10814978023308 | Fiber Post Shape Tapered; 5x 1.25 mm, 1.375 mm, 1.50 mm Posts; 1x 1.25 mm, 1.375 mm, 1.50 mm Dri |
| 10814978023292 | Fiber Reinforced Post; Shape - Parallel; Trial Kit; 5 x 1.25 mm Posts, 1 x 1.25 mm Drill |
| 10814978023285 | Fiber Post: Shape Parallel 5x 1.00 mm, 1.25 mm, 1.50 mm Posts; 1x 1.00 mm, 1.25 mm, 1.50 mm Dril |
| 10814978022523 | Fiber Post; 1.50 mm Posts; Shape - Original |
| 10814978022516 | Fiber Post; 1.25 mm Posts; Shape - Original |
| 10814978022509 | Fiber Post; 1.00 mm Posts; Shape - Original |
| 10814978022493 | Fiber Post; 1.50 mm Posts; Shape - Original |
| 10814978022486 | Fiber Post; 1.25 mm Posts; Shape - Original |
| 10814978022479 | Fiber Post; 1.00 mm Posts; Shape - Original |
| 10814978022462 | Fiber Post; 1.50 mm Posts; Shape - Tapered |
| 10814978022455 | Fiber Post; 1.375 mm Posts; Shape - Tapered |
| 10814978022448 | Fiber Post; 1.25 mm Posts; Shape - Tapered |
| 10814978022431 | Fiber Post; 1.50 mm Posts; Shape - Tapered |
| 10814978022424 | Fiber Post; 1.375 mm Posts; Shape - Tapered |
| 10814978022417 | Fiber Post; 1.25 mm Posts; Shape - Tapered |
| 10814978022400 | Fiber Post; 1.50 mm Posts; Shape - Parallel |
| 10814978022394 | Fiber Post; 1.25 mm Posts; Shape - Parallel |
| 10814978022387 | Fiber Post; 1.00 mm Posts; Shape - Parallel |
| 10814978022370 | Fiber Post; 1.50 mm Posts; Shape - Parallel |
| 10814978022363 | Fiber Post; 1.25 mm Posts; Shape - Parallel |
| 10814978022356 | Fiber Post; 1.00 mm Posts; Shape - Parallel |
Trademark Results [FibreKleer 4x]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FIBREKLEER 4X 85174581 4103048 Live/Registered |
Pentron Clinical Technologies, LLC 2010-11-11 |
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