| Primary Device ID | 00850001745710 |
| NIH Device Record Key | e1e7f96b-f600-4435-af32-65464ddc529e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PB Access |
| Version Model Number | 9000016 |
| Company DUNS | 026444360 |
| Company Name | DENTAL ENGINEERING LABORATORIES, LLC |
| 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 | true |
| 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 |
| Phone | 805-963-2118 |
| info@planbdental.com | |
| Phone | 805-963-2118 |
| info@planbdental.com | |
| Phone | 805-963-2118 |
| info@planbdental.com | |
| Phone | 805-963-2118 |
| info@planbdental.com | |
| Phone | 805-963-2118 |
| info@planbdental.com | |
| Phone | 805-963-2118 |
| info@planbdental.com | |
| Phone | 805-963-2118 |
| info@planbdental.com | |
| Phone | 805-963-2118 |
| info@planbdental.com | |
| Phone | 805-963-2118 |
| info@planbdental.com | |
| Phone | 805-963-2118 |
| info@planbdental.com | |
| Phone | 805-963-2118 |
| info@planbdental.com | |
| Phone | 805-963-2118 |
| info@planbdental.com | |
| Phone | 805-963-2118 |
| info@planbdental.com | |
| Phone | 805-963-2118 |
| info@planbdental.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850001745710 [Primary] |
| EJL | Bur, Dental |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850001745710]
Moist Heat or Steam Sterilization
[00850001745710]
Moist Heat or Steam Sterilization
[00850001745710]
Moist Heat or Steam Sterilization
[00850001745710]
Moist Heat or Steam Sterilization
[00850001745710]
Moist Heat or Steam Sterilization
[00850001745710]
Moist Heat or Steam Sterilization
[00850001745710]
Moist Heat or Steam Sterilization
[00850001745710]
Moist Heat or Steam Sterilization
[00850001745710]
Moist Heat or Steam Sterilization
[00850001745710]
Moist Heat or Steam Sterilization
[00850001745710]
Moist Heat or Steam Sterilization
[00850001745710]
Moist Heat or Steam Sterilization
[00850001745710]
Moist Heat or Steam Sterilization
[00850001745710]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-30 |
| Device Publish Date | 2022-08-22 |
| 10850001745724 | PlanB Large Access Diamond Bur 28mm-Pack of 10 |
| 10850001745717 | PlanB Small Access Diamond Bur 26mm-Pack of 10 |
| 10850001745700 | PlanB Surgical #6 Carbide Bur-Pack of 10 |
| 10850001745694 | PlanB Surgical #4 Carbide Bur-Pack of 10 |
| 10850001745687 | PlanB Surgical #2 Carbide Bur-Pack of 10 |
| 10850001745670 | PlanB Round End Cross Cut Fissure Bur-Pack of 10 |
| 10850001745663 | PlanB Surgical Medium Diamond Bur -Pack of 10 |
| 10850001745656 | PlanB Xtra Course Diamond Bur -Pack of 10 |
| 00850001745727 | PlanB Large Access Diamond Bur 28mm |
| 00850001745710 | PlanB Small Access Diamond Bur 26mm |
| 00850001745703 | PlanB Surgical #6 Carbide Bur |
| 00850001745697 | PlanB Surgical #4 Carbide Bur |
| 00850001745680 | PlanB Surgical #2 Carbide Bur |
| 00850001745673 | PlanB Round End Cross Cut Fissure Bur |
| 00850001745666 | PlanB Surgical Medium Diamond Bur |
| 00850001745659 | PlanB Xtra Course Diamond Bur |
| 00850001745642 | PlanB Minimally Invasive Bur Kit 24 burs |