FDA.reportPublic FDA data

PB Access

Primary DI
10850001745694
Brand
PB Access
Company
DENTAL ENGINEERING LABORATORIES, LLC
Model
9000005
Device description
PlanB Surgical #4 Carbide Bur-Pack of 10
Published
2022-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJLBur, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850001745694PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085000174569410850001745694

GMDN Terms#

Term, Definition table
TermDefinition
Carbide dental bur, reusableA rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
805-963-2118info@planbdental.com

Regulatory Flags#

DUNS number
026444360
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850001745826Dental Engineering Lab-TFRKZTip-S7211919-Z2024-09-20
00850001745833Dental Engineering Lab-TFRKZTip-E7210519-Z2024-09-20
00850001745116Dental Engineering Lab-TFRKTFRK-MTTFRK-MT2018-10-08
00850001745130Dental Engineering Lab-TFRKTFRK-CSTFRK-CS2018-10-08
00850001745628Dental Engineering Lab-TFRKTFRK-SET+2022-08-22
00850001745635Dental Engineering Lab-TFRKTFRK-EMS+2022-08-22
00850001745642PB Access90000002022-08-22
00850001745659PB Access90000102022-08-22
00850001745666PB Access90000112022-08-22
00850001745673PB Access90000122022-08-22
00850001745680PB Access90000132022-08-22
00850001745697PB Access90000142022-08-22
00850001745703PB Access90000152022-08-22
00850001745710PB Access90000162022-08-22
00850001745727PB Access90000172022-08-22
10850001745656PB Access90000012022-08-22
10850001745663PB Access90000022022-08-22
10850001745670PB Access90000032022-08-22
10850001745687PB Access90000042022-08-22
10850001745700PB Access90000062022-08-22

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00810226100022AiraAIRA, LLCEJL2026-08-25
00810226100060AiraAIRA, LLCEJL2026-08-25
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00810226100275AiraAIRA, LLCEJL2026-08-25
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00810226101043AiraAIRA, LLCEJL2026-08-25
00810226101050AiraAIRA, LLCEJL2026-08-25
00810226101081AiraAIRA, LLCEJL2026-08-25