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 |
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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 |