PB Access

GUDID 10850001745656

PlanB Xtra Course Diamond Bur -Pack of 10

DENTAL ENGINEERING LABORATORIES, LLC

Diamond dental bur, reusable
Primary Device ID10850001745656
NIH Device Record Key430daca0-b3d4-497f-a0c1-8a5bc9617961
Commercial Distribution StatusIn Commercial Distribution
Brand NamePB Access
Version Model Number9000001
Company DUNS026444360
Company NameDENTAL ENGINEERING LABORATORIES, LLC
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone805-963-2118
Emailinfo@planbdental.com
Phone805-963-2118
Emailinfo@planbdental.com
Phone805-963-2118
Emailinfo@planbdental.com
Phone805-963-2118
Emailinfo@planbdental.com
Phone805-963-2118
Emailinfo@planbdental.com
Phone805-963-2118
Emailinfo@planbdental.com
Phone805-963-2118
Emailinfo@planbdental.com
Phone805-963-2118
Emailinfo@planbdental.com
Phone805-963-2118
Emailinfo@planbdental.com
Phone805-963-2118
Emailinfo@planbdental.com
Phone805-963-2118
Emailinfo@planbdental.com
Phone805-963-2118
Emailinfo@planbdental.com
Phone805-963-2118
Emailinfo@planbdental.com
Phone805-963-2118
Emailinfo@planbdental.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110850001745656 [Primary]

FDA Product Code

EJLBur, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10850001745656]

Moist Heat or Steam Sterilization

[10850001745656]

Moist Heat or Steam Sterilization

[10850001745656]

Moist Heat or Steam Sterilization

[10850001745656]

Moist Heat or Steam Sterilization

[10850001745656]

Moist Heat or Steam Sterilization

[10850001745656]

Moist Heat or Steam Sterilization

[10850001745656]

Moist Heat or Steam Sterilization

[10850001745656]

Moist Heat or Steam Sterilization

[10850001745656]

Moist Heat or Steam Sterilization

[10850001745656]

Moist Heat or Steam Sterilization

[10850001745656]

Moist Heat or Steam Sterilization

[10850001745656]

Moist Heat or Steam Sterilization

[10850001745656]

Moist Heat or Steam Sterilization

[10850001745656]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-30
Device Publish Date2022-08-22

On-Brand Devices [PB Access]

10850001745724PlanB Large Access Diamond Bur 28mm-Pack of 10
10850001745717PlanB Small Access Diamond Bur 26mm-Pack of 10
10850001745700PlanB Surgical #6 Carbide Bur-Pack of 10
10850001745694PlanB Surgical #4 Carbide Bur-Pack of 10
10850001745687PlanB Surgical #2 Carbide Bur-Pack of 10
10850001745670PlanB Round End Cross Cut Fissure Bur-Pack of 10
10850001745663PlanB Surgical Medium Diamond Bur -Pack of 10
10850001745656PlanB Xtra Course Diamond Bur -Pack of 10
00850001745727PlanB Large Access Diamond Bur 28mm
00850001745710PlanB Small Access Diamond Bur 26mm
00850001745703PlanB Surgical #6 Carbide Bur
00850001745697PlanB Surgical #4 Carbide Bur
00850001745680PlanB Surgical #2 Carbide Bur
00850001745673PlanB Round End Cross Cut Fissure Bur
00850001745666PlanB Surgical Medium Diamond Bur
00850001745659PlanB Xtra Course Diamond Bur
00850001745642PlanB Minimally Invasive Bur Kit 24 burs
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.